Search Trials

Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the production of other normal cells and these cannot perform their usual functions. Therefore patients with AML or ALL are vulnerable to infection, anemia, and bleeding.

The purpose of this study is to understand what causes the white blood cells to grow abnormally, and to determine if there are novel agents that can be used to stop this abnormal growth. In this research project, a sample of blood and bone marrow will be studied in the laboratory to learn more about the nature of the disease, and to understand what causes the defect in the growth of these cells.

The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) tissue. Tissues from patients (with cancer as well as from those without), who are undergoing pancreatic surgery, will be used in this research.

Share your health data and a little blood to help with studies on all kinds of diseases— cancer, diabetes, heart disease. A ready pool of samples and treatment histories speeds up research. It’s simple to help. And your info is so important to the search for new ways to prevent and treat illnesses.

Want to make an impact in just 20 minutes? Give some blood, answer some questions, and share your health records with your study team’s database. Researchers use it to find disease patterns and search for new ways to prevent and treat illnesses.

Recruiting Research Participants for a New Study on the “Genetics of Prostate Cancer”

At the time of conception, fertilization of the egg by the sperm brings together the genetic material (DNA) from both parents, half from the mother and half from the father, producing the embryo. In the very early stages of embryonic development, the embryo is made up of cells that have the potential to develop into all types of cells, like skin, muscle, liver, brain, pancreas, breast, ovary, fallopian tube, or prostate cells. Because of this ability, these cells are called “pluripotent” embryonic stem cells (ESCs). However, about a week after fertilization, the embryonic cells lose their ability to develop into all of the different cells and tissues of the body and gradually “differentiate” into the various tissues and organs that have different specific functions. So, there is a relatively narrow window during which pluripotent ESCs exist in the embryo.

At the end of the in vitro fertilization (IVF) process for couples undergoing subfertility treatment, the doctors are usually left with one-week-old embryos. In 1998, using such embryos for research, scientists figured out how to grow pluripotent ESCs in the lab that can stay in their pluripotent state if the right growth conditions are present. Changing the growth conditions in certain ways, scientists learned how to stimulate the ESCs to go through a process called “differentiation,” in which the stem cells can develop into any of the different cell types present in the body. ESCs were used in the early animal cloning experiments that produced the cloned ewe named “Dolly;” however, cloning human cells is illegal. While ESCs offer promising and exciting opportunities, like the possibility of growing organs in the lab, because their production involves technical and ethical problems, efforts were directed to produce pluripotent stem cells from mature cells to avoid the use of embryos.

In 2007, Japanese researchers found an amazing way (for which they received a Nobel Prize) to transform mature cells, like regular skin or blood cells, directly into stem cells without using human eggs. They found a combination of proteins that, if injected into mature cells, gradually reprogrammed them into induced pluripotent stem cells, abbreviated iPSCs.

Research Project

Drs. Dan Theodorescu and Clive Svendsen, the Principal Investigators at the Cedars-Sinai Medical Center in Los Angeles, California in collaboration with Dr. William Catalona, the Principal Investigator at Northwestern University are engaged in research using iPSCs to develop a model of human prostate cancer using iPSCs from men who carry BRCA2 mutations that are related to a higher risk for developing aggressive prostate cancer (the Cedars-Sinai team has already accomplished this for ovarian cancer in women who carry BRCA1 mutations). As study controls, they will also enroll men with non-BRCA2-related prostate cancer and those without prostate cancer. They will not use embryos.

In the laboratory, the researchers will take the white blood cells from a blood sample back in time to when they were capable of making any cell type in the body and differentiate them forward into prostate cells carrying (or for non-BRCA2-mutation carriers, not carrying) the BRCA2 mutation in a petri dish. Using these transformed prostate cells, they will use current genetic engineering and molecular biology research methods to study the mechanisms of the transformation of normal prostate cells into aggressive prostate cancer cells. This model also can be used in cell-signaling studies and drug screening studies for designing future therapies. The bank of prostate iPSCs that they will create may be shared with research institutions around the world.

These researchers are now recruiting men and their male family members who carry a BRCA2 mutation and other prostate cancer patients and controls without prostate cancer to participate in this study. This research is being performed to discover the causes of prostate cancer and how it is passed down in families using the BRCA2 mutation as a model system and also can be applied to non-BRCA2-related cancers.

This study is called “The genetics of prostate cancer” and is approved by the Institutional Review Boards at Northwestern University (STU00018651) and Cedars Sinai, whose function is to protect the rights of research subjects and to oversee ethical issues. Participation in this study will involve having up to 50 ml of your blood drawn (10 teaspoons), and completing family history questionnaires (baseline and follow-ups) and clinical follow-up questionnaires, if applicable. The time involved includes the time required to read the 10-page consent form, and the time required to travel to Northwestern Memorial Hospital, Galter Pavilion, 675 North St. Clair Street, Chicago, IL 60611 for the research blood draw.If it is not convenient for you to come to our clinic you may be able to get blood drawn at a clinic of your choice and we will arrange to have it shipped to Cedars-Sinai in Los Angeles, California. It will take about 20 to 40 minutes to complete the questionnaire. In the case that your family history suggests familial prostate cancer, Dr. Catalona may want your family members to participate in the study as well. You may be asked to contact your relative(s) about the study. We will follow up with a family history follow-up questionnaire annually, which takes 15 to 30 minutes to finish, to update the file. If you develop prostate cancer, we will want you to fill out a clinical follow-up questionnaire about prostate cancer and follow you up with the questionnaire annually as well, which takes 10 minutes to finish.

In addition, we may request up one or more additional blood samples of 10 to 20 ml (2-4 teaspoons) from you at a later date, depending on the evolving needs of the study. You may refuse to provide these follow-up blood samples without affecting your participation in this study. The blood sample(s) will be saved for future analysis. Efforts will be made to limit the use and disclosure of your personal information, including research studies and medical records, to people who have a need to review this information. We cannot promise complete secrecy. Organizations that may inspect and copy your information include the IRB and other representatives of this institution.

Research results will not be available to you or your physician except under extraordinary circumstances. These are situations in which a life-threatening medical disorder is discovered for which medical treatment is available to prevent or alleviate long-term medical complications. If such a situation should occur, we will contact you via phone, email or mail.

Those interested in participating may contact Dr. Catalona at 312 695-4471 or william.catalona@nm.org.

Further background information on stem cells is available from the author who created the background information for this article: Meshorer E (2020) What Are Embryonic Stem Cells and How Can They Help Us?. Front. Young Minds. 8:32. doi: 10.3389/frym.2020.00032. Copyright © 2020 Meshorer

The main purpose of this project is to collect samples for research. The samples will be stored at the Pathology Core Facility (PCF) of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School (NUMS). PCF serves as the centralized resource that addresses the sample collection needs for the research community. The samples collected can be used by researchers at Northwestern University and third party commercial and non-profit institutions who have approval from their Institutional Review Board (a committee which is responsible for the ethical oversight of the study) for their projects.

You will be asked to donate a sample of blood. In addition, any extra tissue or fluid from what has been collected from you for your routine care will be used. Examples of samples include but are not limited to tissue, blood, urine, and bone marrow.

The purpose of this research study is to help advance the scientific understanding of breast cancer. A portion of breast or skin tissue and a sample of blood, along with clinical information, will be collected and stored in a database for research purposes only.

Only tissue or fluid in excess of that required for clinical diagnosis and/or staging will be collected. Specific clinical data will include: treatment for cancer (surgical procedures, chemo or hormone therapy, radiation), cancer outcome (recurrence, metastases, death due to disease, and death without disease, alive, alive with disease).

In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect them.

The purpose of this study is to learn about how CML leukemia cells become resistant to medications or progress to acute leukemia (blast crisis). This may prove to be helpful in the design of new more effective drugs for the treatment of CML in the future.

In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop leukemia cells from growing. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it was developed to replace older paper methods for collecting and storing information.

The purpose of this study is to allow researchers involved with the NBTIDB to use data stored in it for future research studies and projects. The NBTIDB also allows researchers to track whether or not patients have agreed to allow their information to be linked to their leftover tissue samples, which are kept in the hospital’s pathology department, for future research studies.

Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to identify specific treatment approaches for patients at a high risk for relapse. One characteristic associated with high relapse rates is an increase in proteins that are referred to as Hox proteins in the leukemia cells. Increase in Hox proteins prevents production of some other proteins, including a protein referred to as Triad1. An increase in Triad1 protein in bone marrow cells may be important to control the growth of such cells. Decreased Triad1 in leukemia cells may therefore promote their growth, but this has not been previously studied.

The purpose of this study is to investigate if the lack of Triad1 in leukemia cells contributes to resistance of some leukemias to chemotherapy drugs. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

At a time when you are having a bone marrow biopsy and aspirate performed as part of your standard medical care, about an additional 2.5 teaspoons (12.5 mL) of bone marrow will be collected for this research study.

Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be about how genes affect the development of cancer, response or resistance to treatment as well as prognosis (course of disease and overall outcome including survival). Other studies may aim to identify measurable substances in the blood and/or urine (known as biomarkers) that can indicate early development of cancer, worsening or relapse of disease and response to treatment. Some studies may lead to new products, such as drugs or tests for detection of cancer.

The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct studies to learn more about the subtypes of head and neck cancers and determine the most effective treatments. The registry will also allow us to identify possible subjects for future studies.

This study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer will be collected and utilized for future research projects known as biomarker studies. These blood based laboratory tests will ultimately evaluate molecules present in the blood of patients with breast cancer. These molecules could be, for example, a protein, tumor DNA, or tumor cells circulating in the blood. As research technology advances, blood samples from patients with breast cancer may help in understanding the course of disease and to check as to how effective a treatment is.

The purpose of the study is to gather information about your cancer and the treatment you receive as a part of your routine clinical care. In this study, we are developing a research registry, which is a bank of information about many patients.

We are interested in learning about the relationship between your cancer and the different types of tests available to identify the best treatment option for you. That is, we are interested in the tests that identify possible ‘mutations’ (e.g., changes) or ‘drivers’ within your tumor, what treatments you receive after getting these tests, and how your cancer responds to the treatments.

The tests known as next generation sequencing or “NGS” are usually done on your cancer tissue or blood samples as a part of your routine clinical care. Your doctor can use the information to identify the best treatment option for you after discussing it with other doctors. These routine tests will be performed whether you participate in this study or not, but we want to collect the information about this process for this study.

If you participate in this study, extra samples of your blood will be collected and stored, and your health information from your medical record and NGS lab results will be collected and stored.

The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine, and fecal samples (collectively called “tissue”) for research studies to help us understand melanoma and other skin cancers. Biopsies and surgery of your cancer will not be a part of this study but will be performed as part of your standard care.

The purpose of this study is to test your tumor tissue for certain biomarker (which may be the cause of your cancers, such as specific mutations in certain proteins). This will help determine your eligibility to participate in either matched sub-studies involving investigational agents that targets the specific mutated protein or alternatively to un-matched sub-studies.

Thepurpose of this study is to test the good and bad effects of the combination ofdrugs called inotuzumab ozogamicin and blinatumomab. The study doctors hope tolearn if the combination of study drugs will cause cancer to go away andprevent leukemia from coming back.

Inotuzumabozogamicin and blinatumomab have already been approved by the FDA to treatrelapsed or refractory ALL as well as other cancers. The combination ofinotuzumab ozogamicin and blinatumomab is considered investigational for thisstudy.

Participantswith ‘untreated ALL’ or ‘relapsed or refractory ALL’, will get a combination ofdrugs called inotuzumab ozogamicin and blinatumomab. This combination of drugsis known to be effective in patients with relapsed or refractory leukemia, butit is not the usual chemotherapy for patients with ‘untreated ALL.’Participants will also get a drug called methotrexate to prevent cancer cellsfrom entering the central nervous system.

In the study, there will be many patients, like you, with hepatocellular carcinoma (HCC) who are eligible to receive a treatment called Y90 radioembolization and who may also be liver resection candidates.

Y90 radioembolization is a non-invasive, out-patient treatment that uses radioactive beads (microspheres), which are tiny glass particles that are loaded with radiation. The beads are injected into an artery of the liver that supplies blood to the tumor(s). The beads flow to the tumor(s) and become trapped inside. The beads release the Y90 radiation inside the tumor(s).

Liver resection is used to remove the part of the liver that has the liver tumor(s). It has been shown that Y90 radioembolization can increase the untreated liver’s size and volume. Patients with HCC may be liver resection candidates if they have a large enough liver.

The purpose of this research is to determine if there is an ideal Y90 dose to increase liver volume. This research may help determine the best Y90 dose for future patients who need a larger liver to have a liver resection.

If you participate in this study, you will have standard-of-care Y90 radioembolization as well as study-specific imaging and two optional liver biopsies. You will participate in the study for up to 3 months. Your health status will continue to be followed for up to 5 years.

Patients enrolled in the study will receive up to $195.00 for their participation.

The purpose of this study is to compare the treatment of carboplatin/paclitaxel and letrozole hormonal therapy to letrozole alone. The use of the hormonal therapy drug letrozole without chemotherapy may shrink or stabilize cancer in the same way that chemotherapy also does, but without the added side effects of chemotherapy. Letrozole is a drug called an aromatase inhibitor, which indirectly stops the body from producing estrogen.

This study will investigate if this approach is better, the same, or worse than the usual approach. In order to determine if the use of letrozole alone helps to improve treatment for patients with low-grade serous ovarian or peritoneal cancer compared to combined chemotherapy and letrozole, half of patients in this study will receive letrozole with paclitaxel/carboplatin and the other half will receive letrozole alone. The study doctors will be looking to see if the letrozole alone prolongs the time cancer is in remission, or the duration of time participants are alive after treatment.

Letrozole is approved by the FDA for breast cancer, but is not FDA approved for ovarian cancer and is therefore considered experimental in this setting.

Participants will get either the combination of paclitaxel and carboplatin for four and a half months followed by letrozole or letrozole alone. Patients who are assigned to letrozole monotherapy will continue taking the letrozole for as long as they are tolerating the drug (i.e., have not developed any allergies or severe side effects with the medication) and have not experienced a recurrence or progression of their disease.

After participants finish their study treatment, their doctor and study team will continue to follow their condition and watch for side effects during clinic visits or by phone. Participants will be checked every 3 months for the first 3 years after treatment. After that, this will happen every 6 months for two years.

The purpose of this study is to test good and bad effects of different drugs against metastatic brain tumors with altered genes. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients such as you. Researchers have looked at the DNA material (genes) that can be affected in brain metastases and have found several genes that are altered, or mutated. There are medications that target these genes.

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your metastatic cancer. The usual approach is defined as care most people get for your metastatic cancer.

Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate.

However, significant limitations remain with this approach, including a significantly increasing risk of post-biopsy infection. This arises because more than 97% of all prostate biopsy are performed via a transrectal approach that introduces rectal bacteria with each pass of the biopsy needle into the sterile urinary tract. The current risk of post-transrectal biopsy infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually.

Transperineal biopsy is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is perfomed without antimicrobial prophylaxis, instead passes the biopsy needle through the perineal skin and pelvic floor.

Transperineal biopsy has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second, when transrectal biopsy was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge.

Beyond the potential for in-office transperineal biopsy to significantly reduce or eliminate biopsy infections, transperineal biopsy may also improve cancer detection: studies of transperineal biopsy (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to transrectal biopsy. This is notable, as anterior tumors are difficult to sample with transrectal. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers.

Although transrectal biopsy is used widely, it is associated with a significant and increasing risk of biopsy infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate biopsy. The study investigators have refined a transperineal approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. The investigators hypothesize that transperineal MRI targeted biopsy will: (1) largely eliminate post-biopsy infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to transrectal MRI targeted biopsy; and (3) have significantly better detection of prostate cancer.

This multi-center randomized controlled trial will be conducted to evaluate in-office transperineal MRI targeted vs. transrectal MRI targeted biopsy, the current gold standard. This has transformative impact to change current standard of practice.

The purpose of this research study is to determineif the experimental therapy called JCAR017 is effective and safe to treatFollicular Lymphoma or Marginal Zone Lymphoma.

This study will have 4 cohorts or patientgroups. Assignment to one of these patient groups depends on if you haveFollicular Lymphoma or Marginal Zone Lymphoma and the number and type oftreatments that you have received in the past, as well as how long it took foryour lymphoma to return after your last treatment. Everyone in all 4 patientgroups will receive the same dose of JCAR017 T cells. JCAR017 is a type oftherapy known as chimeric antigen receptor (CAR) T cell therapy which isco-developed with Juno Therapeutics. The visit schedule will also be the samefor all 4 patient groups. At the time you decide to take part in the study andgo through the screening procedures, it will be determined which patient groupyou will be assigned to.

In this study, your immunecells will be collected from your blood in a procedure called leukapheresis.The T cells will be separated from the collected immune cells and will bemodified in a laboratory. In the laboratory, a new gene will be put into your Tcells using genetic modification techniques. After they have been modified, thecells will be grown in the laboratory to reach the expected dose for thetreatment. Adding in the new gene may enable your T cells (now called JCAR017 Tcells) to bind to the CD19 protein, which your type of cancer cells carry ontheir surface. Binding to these cells activates the JCAR017 T cells, and theyattack the cancer cells. The JCAR017 T cells will persist in your body afterattacking the cancer cells, you will be monitored during the study to evaluatehow long these JCAR017 T cells persist. The JCAR017 T cells will be given backto you via infusion (IV).

Note:This is only a partial description of treatment. Please contact the Robert H.Lurie Comprehensive Cancer Center of Northwestern University if you areinterested in the trial.

Primary Aim:

To determine the 28-daymortality rate from the time of COVID 19 diagnosis for CLL patients infectedwith SARS-CoV2 at MSKCC and other institutions.

Secondary Aims:

To describe baseline characteristics, prior and current CLL directed therapies, COVID19 clinical course and outcomes for CLL patients infected with SARS-CoV2.

To examine relationships between CLL directed therapy and COVID19 disease course and outcomes.

To examine current practices regarding management of CLL directed therapy in CLL patients infected with SARS-CoV2.

All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. A computer will by chance assign patients to one of the two arms in the study. This is called randomization.

•Arm A: Carboplatin + Pemetrexed + Avastin + Tecentriq

•Arm B: Carboplatin + Pemetrexed + Avastin

Arm A: Participants will receive carboplatin, pemetrexed, Avastin and Tecentriq for 4 cycles in the treatment phase, followed by pemetrexed, Avastin and Tecentriq for the rest of the cycles, called the maintenance phase.

Arm B: Participant will receive carboplatin, pemetrexed and Avastin for 4 cycles in treatment phase, followed by pemetrexed and Avastin during the following cycles of the maintenance phase.

Participants will be asked to take the study drugs as long as they are benefitting from the treatment or their disease does not get worse. Participants will be removed from the study if the study doctor thinks that they have unacceptable toxicities due to the study drug/s and it is in their best interest to stop participating in the study.

All the drugs will be administered intravenously on Day 1 of each cycle. Each cycle is made of 21 days. The number of cycles will depend on how participants respond to treatment. During the study, participants will have a CT scan every 6 weeks (every 9 weeks during the maintenance phase). Participants will also undergo a physical exam, blood tests, performance status, and vital signs. Blood will be collected during the study. A biopsy for tissue will be collected if the participant agrees.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be implanted at the end of the procedure. In phase 1, about two weeks after surgery, patients will undergo sonication and albumin-bound paclitaxel administration with MRI to quantify extent of blood brain barrier opening. Sonication and administration of albumin-bound paclitaxel will continue every 3 weeks until disease progression. The planned albumin-bound paclitaxel starting dose is 40 mg/m2, to be escalated in the absence of significant toxicity up to 260 mg/m2. Blood samples for circulating tumor DNA will also be collected before and after each sonication. In phase 2, pre-sonication carboplatin at AUC 5 will be added to the regimen, with a safety run-in for the first 6 patients.

The purpose of this Managed Access Program(MAP), which is an intermediate size patient

population Expanded Access, is to allowtreatment with tisagenlecleucel (CTL019) for eligible

patients diagnosed with B-cell acutelymphoblastic leukemia (ALL) or large B-cell lymphomas who meet all of thefollowing criteria: are 1) consistent with the approved prescribing information,2) unable to receive commercially manufactured product due to failure of the incomingapheresis material to meet acceptance specifications or final outgoing productto meet the commercial release specifications or other specification within theprescribing information, and 3) where no overwhelming safety concerns has beenidentified for manufacture and release of the out of specification product.

Participation inthis treatment plan involves an experimental approach called gene transfer forALL or large B-cell lymphoma that involves cells in your blood called B cells(your tumor cells and also normal antibody-producing cells). During thistreatment, some of your own white blood cells (T cells) will be taken andchanged to turn against your tumor cells. T cells from your body will bechanged in a way that may allow them to identify and kill your tumor cells.This change may allow your T cells to go to the tumor cells, turn"on" and potentially kill the tumor cells. The modification is doneby gene transfer and results in a genetic change to your T cells. This mayallow the changed T cells to recognize your tumor cells but also normalantibody-producing cells called B cells. These changed cells are calledtisagenlecleucel cells.

If you are eligible andchoose to participate in this MAP, you will be asked to come to the doctor’soffice/clinic/study site at least 3 times in order to make sure you areeligible to receive the tisagenlecleucel cells, and to prepare you for theexperimental treatments. Once you receive the tisagenlecleucel cells, acaregiver, relative, or friend should be in your presence at all times for thefirst 10 days to monitor your well-being and contact your study physician incase of fever or changes in your condition. If you become ill, immediatelycontact your study physician. Additionally, you may be required to spend about4 weeks after you have received tisagenlecleucel cells in close proximity tothe trial treatment center while the doctor and study team see how thetreatment is working and monitor your safety.

Note:This is only a partial description of treatment. Please contact the Robert H.Lurie Comprehensive Cancer Center of Northwestern University if you areinterested in this Managed Access Plan (MAP).

The purpose of this study is to test the safety of a drugcalled M3814 in combination with avelumab and hypofractionated radiation. This combination of drugs has been tested inanimals but has not been tested in people. This study tests different doses of the drug to see which dose is saferfor people.

Participants enrolled in Phase 1 will get standard dose ofradiation therapy every other day over 10 days. This will be followed by a combination of avelumab and M3814 for as long as your doctor feels that the combination ishelping you and you are not experiencing too many side effects.

Phase 2:

Phase 2 has twostudy groups:

Group 1 Participants in Group 1 will receive radiation therapy and the study drugsavelumab and M3814. These drugs are not approved by the FDA for treatment of your disease.

Group 2 Participants in Group 2 will receive radiation therapy and the study drug avelumab.Avelumab is not approved by the FDA for treatment of yourdisease.

All participants, regardless of which phase they areenrolled in, will be followed for 12 months and watched for side effects.Participants will be asked to return to the clinic approximately 30 days aftertheir last dose of study treatment. Afterthat time, participants will be contacted by telephone at regular intervals forup to five years.

This study is being done to answer the following question:

Can we increase the chance of your pancreatic cancer staying away by giving you chemotherapy before and after surgery?

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your pancreatic cancer. The usual approach is defined as care most people get for removable pancreatic cancer.

About the Study

Opt2Move is a 6-month smartphone-based study to help adolescent and young adult cancer survivors become more active.

What’s involved?

Assessments

Complete before starting study and at 3 and 6 months:

• 45-min online survey
• Wear activity monitor 24/7 for 7 days
• You will be compensated for assessment completion

Physical Activity Program

All Participants

• Receive Fitbit, Opt2Move app, exercise prescription, 15-min orientation call
• Track physical activity with Fitbit and use Opt2Move app daily
• Additionally, you may receive 0-4 additional Opt2Move features focused on mindfulness and/or social support.

How can I learn more?

For questions: Phone: 312-503-3465; Email: O2M@nm.org

To complete online screening: https://redcap.link/O2M

The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulating tumor cells (CTCs) in the blood. Circulating tumor cells are cancer cells that are shed from the tumor into the blood stream and are believed to be one of the first indicators that breast cancer cells may remain after surgery. Approximately 20% of women with early-stage breast cancer can be found to have CTCs in a small sample of blood taken several weeks after surgery. Radiotherapy is used after surgery to remove a breast cancer in order to sterilize any cancer cells that may be remaining in the breast. It is not known if radiotherapy can help decrease or eliminate CTCs that are found in the blood. This study aims to find out if testing for CTCs can be clinically useful for guiding radiotherapy treatment decisions. Another aim of this study is to evaluate whether CTCs can be used to measure the effectiveness of radiotherapy in an individual patient.

The purpose of this study is to compare the usual treatment alone

to using PET/CT imaging to look for cancer that has spread to the pelvis plus the usual treatment.

We want to see if we can provide a more targeted treatment to this type of cancer by treating up to 5

specific lesions that are seen on the PET/CT scan. Part of the purpose of this study is also to see

whether adding apalutamide and directed radiation works better than the usual approach to help treat

prostate cancer that has returned after surgery.

This study will help the study doctors find out if this different approach is better than the usual

approach. To decide if it is better, the study doctors will be looking to see if the study approach

increases the time before cancer growth or if the cancer causes major additional symptoms.

This study has 4 study groups. Participants will be assigned to 1 of 4 possible treatment groups

depending on the results of your PET/CT scan. After you finish your study treatment, your doctor will

continue to follow your condition for up to 10 years and watch you for side effects and monitor the

progression of your cancer.

Group 1 (Negative for Extra Pelvic-Metastases)

If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

to outside of the pelvis. You will get the usual appropriate care that is used to treat this type of

cancer, the planned standard of care treatment with radiation therapy (SOC RT) and STAD for 6 months.

Group 2 (Negative for Extra Pelvic-Metastases)

If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

to areas outside of the pelvis. You will get a study treatment, planned SOC RT + STAD + apalutamide

for 6 months.

Group 3 (Positive for Extra Pelvic-Metastases)

If you are in this group, it means that your cancer has spread to areas outside of your pelvis.

You will get planned SOC RT + STAD + apalutamide for 6 months.

Group 4 (Positive for Extra Pelvic-Metastases)

If you are in this group, your cancer has spread to areas outside of your pelvis.

You will get a planned SOC RT + STAD + apalutamide for 6 months + directed radiation therapy to

where the cancer has spread. Each patient will undergo another (or additional) PET/CT scan,

which will take place about one year after starting treatment or if clinically necessary at an

earlier time point.

This study is being done to learn how the microbiome evolves through stem cell transplantation, how it can be shaped by socioeconomic status, the neighborhoods that people reside in, and their diet, as well as certain clinical factors (such as antibiotic usage). Study participants will be asked to provide a saliva sample and complete a questionnaire.

Endometrial intraepithelial neoplasia (EIN), also known as Complex Atypical Hyperplasia (CAH), is a change in the lining of the uterus (also called the endometrium) that can lead to cancer of the uterus. Uterine/endometrial cancer is the most common gynecologic cancer and its incidence is increasing rapidly.

The usual approach for women diagnosed with EIN/CAH is surgical - hysterectomy (removal of the uterus) without any prior medical treatment with pills. But some women may want to avoid hysterectomy because they want to have children, or because there are health risks to major surgery. We are doing this study to see if it is possible to treat EIN by changing the lining of the uterus at the cellular level and prevent it from turning into uterine cancer, without doing a hysterectomy.

Currently, a drug called megestrol acetate, also called megace, can be used for treatment of EIN without surgery. Megestrol acetate is a synthetic version of the human hormone progesterone. It treats breast cancer and endometrial cancer by affecting female hormones involved in cancer growth. However, it has a high failure rate in preventing cancer growth from EIN, and hysterectomy is still needed for most women. The goal of this study is to improve the results of megestrol acetate treatment, by combining it with an anti-diabetes drug called metformin. Although research suggests that metformin may have anti-cancer properties, it has not yet been proven to be safe and effective to treat EIN. We will compare the effectiveness of megestrol acetate alone with the combination of megestrol acetate and metformin in reducing the growth of EIN. If we find that the combination of megestrol acetate with metformin is better at reducing EIN growth than megestrol acetate alone, we will plan further research with this combination to try and prevent EIN from turning into uterine/endometrial cancer. This study is looking for volunteers who have been diagnosed with EIN and are planning a hysterectomy or progestin intrauterine device (IUD) placement. We will enroll 50 participants at institutions across the country.

The purpose of this study is to provide patients access to their nonconforming ide-cel as a treatment option for their disease. The study will evaluate the safety and effectiveness of this therapy through the collection of information.

Participants will be asked to take part in this study if they previously agreed to receive idecabtagene vicleucel (ide-cel), for the treatment of their disease as part of routine care and not a clinical research study. Participants already had the blood collection (leukapheresis) procedure, and your T cells were collected and genetically modified in a laboratory in order to manufacture the ide-cel T cells for your disease treatment.

The ide-cel T cells that were produced do not meet all of the prespecified release criteria to be used as a routine prescription drug as required by the governing health authority. After review of its attributes, this product has been assessed by the Sponsor and your study doctor as potentially effective to treat your disease with potential benefits that outweigh the risks and is being offered to you as a treatment option in a research study.

Approximately 3 months after receiving your nonconforming ide-cel, your participation in this study will end.

The purpose of this expanded access protocol is to allow patients to receive lisocabtagene maraleucel T cells that did not meet all of the prespecified release criteria (nonconforming) to be used as a routine prescription drug. The study will evaluate the safety and effectiveness of this therapy through the collection of information.

Participation in this treatment plan involves receiving the nonconforming product and performing tests as part of your routine clinical care. The information or results from these evaluations will be collected for research purposes.

If you are eligible and choose to participate in this EAP, you will be asked to complete test as part of routine care, you will undergo lymphodepleting therapy (chemotherapy administered to help prepare your bone marrow and immune system to receive lisocabtagene maraleucel), and receive the nonconforming lisocabtagene maraleucel product through your vein as an intravenous (IV) infusion.

Approximately 3 months after receiving your nonconforming lisocabtagene maraleucel, your participation in this study will end.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Participants ages 18 years or older who have high-risk prostate cancer will be enrolled into this study.

This study is being done to answer the following questions:

If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment?

If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment?

The study doctors want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer.

This study has 4 study groups.

If you have a low Decipher risk score, you will be randomly assigned to one of these two study groups:

· Group 1: If you are in this group, you will get the usual approach, hormone therapy and radiation therapy, used to treat this type of cancer.

· Group 2: If you are in this group, you will get the usual radiation treatment and a shorter period of hormone therapy used to treat this type of cancer.

If you have a high Decipher risk score and/or positive pelvic node(s), you will be randomly assigned to one of these two study groups:

· Group 3: If you are in this group, you will get the usual approach, hormone therapy and radiation therapy, used to treat this type of cancer.

· Group 4: If you are in this group, you will get study drugs called apalutamide and abiraterone acetate with prednisone plus the usual approach (hormone therapy and radiation therapy) used to treat this type of cancer.

After you finish your study treatment, your doctor will continue to follow your condition for at least annually and watch you for side effects.

The purpose of this research study is to evaluate an investigational cell and gene treatment called MB-CART2019.1 that may help to eliminate cancer cells in subjects who have relapsed (responded to treatment but then returns) and/or refractory (has not responded to initial treatment) DLBCL. In order to produce the investigational treatment, white blood cells (T-cells) will be collected at the study center by a process called leukapheresis.

Participation in this study is for up to two years, and additionally subjects must enroll in the separate Gene Therapy Long-Term Follow Up protocol for 13 years (total study participation to equal up to 15 years).

The T‑cells (obtained from blood) will be modified in order for them to express molecules called chimeric antigen receptors (CARs) on their surfaces. When the modified cells, called CAR T‑cells, are reinfused into the body, the new receptors will enable them to bind onto specific antigens on cancer cells and by doing so destroy them. The CAR T-cells act as a “living drug” against your cancer cells.

Before your cells are reinfused, participants will first receive a conditioning regimen consisting of two chemotherapy drugs, fludarabine and cyclophosphamide. The conditioning regimen helps make room in the bone marrow for new blood stem cells to grow, and helps prevent rejection of the transplanted cells, as well as helps kill any cancer cells that are in the body.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Participants 18 years or older who have metastatic melanoma, and the cancer has a change in the gene called the BRAF, and is not responsive to treatment with MEK and BRAF inhibitors will be enrolled.

This study has two phases. Phase 1 and Phase 2.

The purpose of Phase 1 is to test the safety of the study drug, tazemetostat, in combination with the usual treatment, dabrafenib and trametinib. This study tests different doses of tazemetostat with the usual dose of dabrafenib and trametinib to see which dose of tazemetostat is safest for people. Tazmetostatis not approved by the FDA for treatment of this type of cancer.

All people taking part in this study will get the same dose of the usual intervention, dabrafenib and trametinib. However, people in this study will get different doses of the study drug, tazemetostat. Once the highest safe dose is found, phase 1 of the study is stopped.

The purpose of Phase II is to compare the combination of tazemetostat, dabrafenib, and trametinib to tazemetostat alone. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is for the study doctors to learn if a genetic test is helpful to decide if tazemetostat is more effective in patients whose cancer has an abnormal EZH2 gene. The combination of tazemetostat, trametinib, and dabrafenib, has not been administered together in patients and the combination of these agents are not FDA approved for the treatment of this type of cancer.

Participants who take part in this study will either get a combination of usual approach of dabrafenib and trametinib, and the study drug, tazemetostat or will get the study drug, tazemetostat alone, until their disease gets worse or the side effects become too severe.

The purpose of this study is to compare the early treatment(before you have symptoms) of venetoclax and obinutuzumab (V-O) to the usual treatment of V-O after you have symptoms. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is to find out how early V-O treatment affects patients’ physical, social, and emotional well-being, compared to patients receiving the standard delayed V-O treatment.

The antibody, obinutuzumab, and the drug, venetoclax are already approved by the FDA for use in patients with previously untreated CLL or SLL. Most of the time these drugs are not used until a patient has symptoms that make treatment necessary.

Participants who decide to take part in this study will either get treatment with venetoclax and obinutuzumab (V-O) that starts before symptoms start (now), or participants will get treatment with venetoclax and obinutuzumab (V-O) that will start after symptoms start (later). For all patients, the treatment with V-O will continue for 12 months or until the cancer gets worse, or the side effects are too great.

After treatment is finished, participants will be followed for up to 10 years after enrollment.

The purpose of this study is to compare the usual treatment with T-DM1 alone toT-DM1 plus tucatinib. This study will help the study doctors find out if this different approach is better than the usual approach. T-DM1 is already approved by the FDA for use in patients with HER2-positive cancer. Tucatinib has not been FDA-approved to treat breast cancer.

Participants who decide to participate will either get treatment with T-DM1 and placebo (a pill that looks like the study drug but contains no medication) or T-DM1 and tucatinib, for up to 14 cycles, unless the breast cancer returns or the side effects become too severe.

After study treatment is finished, the study doctor will follow participants to watch for side effects and for signs of breast cancer returning. This may include a clinic visit every 6 months for 10 years.

The purpose of this research is to evaluate short-term changes in background breast tissue induced by oral tamoxifen or 4-OHT gel in women with atypical hyperplasia or LCIS.

Study participation involves taking Tamoxifen or a placebo capsule by mouth and applying 4-OHT or placebo gel topically to your breast daily for 4 weeks.

Prior to starting the drug and 4 weeks later participants will be asked to complete some tests and exams.

If eligible and willing to participate in this study participants will be randomized to either oral tamoxifen, 4-OHT gel, or a placebo. Neither the participant nor the investigator will know which one he/she is receiving. Participants will be taking a capsule (with or without Tamoxifen) and using a gel (with or without 4- OHT). This study will take about 4-6 weeks to complete.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The purpose of this study is to examine the good and bad effects of taking the study drug sacituzumab govitecan. This study will help the study doctors to find out if taking the study drug, sacituzumab govitecan will help to decrease cancer in the brain more than usual treatment. The study will also help the study doctors understand if taking the study drug extends the time until the cancer gets worse.

Sacituzumab govitecan is not approved by the FDA for use in patients with HER2-negative breast cancer that has spread to the brain. It is approved for use in patients with metastatic triple negative breast cancer that was previously treated.

Participants who are enrolled into this study will get the usual drugs selected by their study doctor that can help to prevent the side-effects that might be caused by the study drug. Participants will also get the study drug, sacituzumab govitecan, during each cycle. Each cycle lasts 21 days. This study has up to 35 cycles (or approximately 2 years).

As long as the cancer does not get worse and participants do not experience severe side effects, and their study doctor determines that it is beneficial for them to remain on study, they will continue to get the study drug until completion of the study.

The main purposes of this study are to learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to patients with ovarian cancer and to look for signs that the study drugs can treat ovarian cancer

The purpose of this study is to assess if the use of a 3D imaging device called the Clarix Imaging Volumetric Specimen Imager (VSI) can help guide and assist surgeons in identifying and removing all positive margins while in the operating room for breast conservation surgery.

If you are undergoing breast conservation surgery and meet all criteria, the 3D imaging device, VSI, will be used to guide and assist the surgeon in identifying and removing all positive margins while in the operating room. The lumpectomy procedure will be performed per standard practice.

If eligible, the lumpectomy procedure will be performed per standard practice. Promptly after excision, the tumor specimen will be imaged using the VSI device to take additional 3D images of the removed tissue during the standard of care surgery.

During surgery, after the tumor has been removed, the investigators will use the VSI device to identify the margins on the main sample. The surgeon will use this information to remove additional tissue from the cavity. The surgeon will then complete the standard of care surgery according to standard of care practices which may include additional shaves of the remaining issue. The amount of tissue removed as a result of VSI-directed shaving will not be more than the amount that your surgeon would normally remove as part of standard of care.

Participants will be asked to come for a post-operative visit as per standard of care and will be followed-up up to 2 months after surgery.

Note: This is only a partial description of the study procedures. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The main goal of this clinical trial is to test benefits of completing online pain coping skills training program in women who have been diagnosed with stage I-III breast cancer, who have completed their primary cancer treatment, who are taking an AI medication, and who have arthralgia. Arthralgia is a type of joint, bone, and muscle pain that is a common side effect of AI medications. The main questions it aims to answer are:

Participants can complete all parts of the study at home. They will:

Research will compare the education group to the education plus online pain coping skills training group to see if online pain coping skills training has the benefits mentioned above.

The purpose is to determine if mycophenolate motfetil (MMF) combine with temozolomide (TMZ) can stop glioblatoma.

Mycophenolate Mofetil is an antimetabolite immunosuppressant and is FDA approved for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplant, and is used in combination with other immunosuppressants.

Group S (Pre-surgical): Window of Opportunity Study, pre-operative MMF and temozolomide (TMZ)

Participants with suspected newly diagnosed or recurrent glioblastoma who plan to have surgical resection are eligible. Study treatment must begin within 7 days after registration. Group S will open in Part 1 after one participant in Group 1 has successfully completed the first dose level DLT period and subsequent DSMB review. The MMF dose for Group S will be adjusted each time DSMB has approved a subsequent dose escalation. The MMF dose for Group S will always be 1 dose level below the current enrolling dose level (the last safe dose level as indicated by the DSMB) in Group 1. Participants will have 5 days of pre-operative MMF (BID) and TMZ (200 mg/m2 QD)

Group 1 (Adjuvant): Adjuvant therapy+ MMF (dose escalation)

Four to six weeks after the completion of chemoradiation, participants will be registered to the study. Study treatment must begin within 7 days after registration. On study, participants will receive maintenance TMZ and MMF. Each maintenance cycle is 28 days long.

TMZ will be taken orally once a day on Days 1-5, at a dose of 150 mg/m2, for up to 6 cycles. On Cycles 2-6, the TMZ dose may be increased to 200 mg/m2 in the absence of toxicity. Starting Cycle 1 Day 1, MMF will be taken orally twice daily for up to 6 cycles (each cycle is 28 days). The dose of MMF will depend on the dose level each participant is accrued to. See MMF Dose Level table in Section 4.2. The DLT period for Group 1 is the duration of Cycle 1 (28 days), and 7 days thereafter.

Group 2 (Chemoradiation): RT + MMF for MGMT unmethylated tumors (dose escalation)

About 4 weeks after surgical resection, participants confirmed to have unmethylated glioblastoma will be registered and treated with concurrent MMF and TMZ (75 mg/m2 daily) and 6 weeks of focal radiation therapy (60 Gy). Study treatment must begin within 7 days after registration. MMF will be taken twice daily for the entire 6 week period of focal radiation therapy. The dose of MMF will depend on the dose level each participant is accrued to.

After radiation therapy, participants will start adjuvant treatment with TMZ. TMZ will be taken orally once a day on Days 1-5, at a dose of 150 mg/m2, for up to 6 cycles. On Cycles 2-6, the TMZ dose may be increased to 200 mg/m2 in the absence of toxicity

The DLT period for Group 2 is the duration of radiation therapy (6 week period), and 7 days thereafter.

Group 3 (Expansion): MMF during RT and during adjuvant phase. Enrollment to begin only AFTER the completion of groups 1 and 2.

About 4 weeks after surgical resection, participants will be registered and treated with concurrent MMF and 6 weeks of focal radiation therapy (60Gy) and concurrent TMZ at a dose of 75 mg/m2 daily. Study treatment must begin within 7 days after registration. After completion of chemoradiation, participants will go on to have adjuvant TMZ (at a dose of 150 mg/m2 on days 1-5 of each cycle, may be up to 200 mg/m2 during cycles 2-6) with concurrent twice-daily MMF for a total of 6 planned cycles (each cycle is 28 days). The dose of MMF during radiation therapy and during adjuvant treatment will be the RP2D determined in dose escalation Groups 1 and 2.

Optune® Device (Tumor Treating Fields) Concurrent use of the Optune® device (TTFields) is permitted, but not required for participation on this study. It’s use will be according to standard of care.

This research study is ultimately designed to evaluate a new drug called BNT152+153. Since this drug is a combination of two investigational drugs called BNT152 and BNT153, the sponsor must first evaluate each of the two drugs separately (called “monotherapy”). “Investigational” means that BNT152 and BNT153, whether given as monotherapy or combination therapy, are not approved by the United States (U.S.) Food and Drug Administration (FDA) or by any regulatory authority in the world.

In this research study, BNT152 monotherapy, BNT153 monotherapy, and BNT152+153 combination therapy will be tested in humans for the first time.

The overall purpose of this research study is to assess the safety and to establish a safe and effective dose of BNT152 and BNT153 when each is given alone (monotherapy) and when given in combination (BNT152+153). The study will also collect information about how well the drug(s) works against cancer.

Purpose

The purpose of this study is to determine if radiation therapy alone is as effective at controlling unfavorable intermediate risk prostate cancer, cancer compared to the usual combination of radiation and hormone therapy.

Who May be Eligible:

Some of the key eligibility criteria include:

· Cytologically or histologically confirmed diagnosis of adenocarcinoma of the prostate.

· Unfavorable intermediate risk prostate cancer

· Age ≥18 years

Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

All prospective patients will undergo screening tests to determine if they are eligible to take part in the study.

This study is being done to collect, process, and store blood samples of plasma cell disorder patients. The collected blood samples will be used for research projects to study the abnormal plasma cells and compare the results to current tests being done. This will provide an opportunity to better understand how a patient is responding to treatment and to assess the stage of the patient’s disease.

This study will use different tests that are not FDA approved. This test is being studied as a less invasive way to monitor amount of disease in a patient (versus invasive bone marrow biopsy). Current blood tests show the levels of the product of the cancer cell - not the levels of the cells themselves. Sometimes the cancer cells do not make this product and can therefore go undetected in standard tests. This study will show the number of cells. These tests will help identify, and analyze circulating plasma cells (CPCs), which are cells that have escaped into the bloodstream (a characteristic of plasma cell disorders). We will also look at any plasma cell components, such as genes in the DNA and RNA. Part of your samples will be used for Next Generation Sequencing (NGS) to evaluate any changes in your genes. NGS is a useful tool that determines the sequence of your DNA.

In this research study, we are examining how effective talazoparib is in patients with metastatic breast cancer with a BRCA mutation in their tumor.

The U.S. Food and Drug Administration (FDA) has not approved talazoparib for your specific disease but it has been approved for metastatic breast cancer with a germline (inherited) BRCA mutation.

Talazoparib is a study drug that inhibits (stops) the normal activity of certain proteins called “poly (ADP-ribose) polymerases” also called “PARPs”. PARPs are proteins (made from genes which are part of your DNA) that are found in all normal and cancer cells that are involved in the repair of DNA. PARPs are needed to repair mistakes that can happen in DNA when cells divide. If the mistakes are not repaired, the defective cell will usually die and be replaced. Cells with mistakes in their DNA that do not die can become cancer cells. Cancer cells may be killed by a study drug, like talazoparib, that stops the normal activity of PARPs. In clinical trials, the use of talazoparib and other PARP inhibitors have shown that these drugs can reduce tumor size and slow tumor growth in some cancer patients with BRCA1 or BRCA2 mutations

Lynch Syndrome (LS) increases the risk of colon cancer and can also increase the risk of other cancers, including cancer of the uterus, ovaries, small bowel, stomach, pancreas, urinary tract, skin and brain. Cancer prevention strategies for people with LS are therefore urgently needed. Using vaccines to train the body’s own immune system to prevent polyps and cancers is a new approach that we plan to test in patients with LS.

We are asking you to take part in this research study because you have been diagnosed with Lynch syndrome and your doctor has previously found polyps or cancer in your colon or rectum. This study is being done to find out if we can lower your chance of getting colon cancer and other Lynch cancers by giving you three vaccines, an approach called Tri-Ad5, in combination with an injectable immune-enhancer protein called N-803.

The usual approach for patients with Lynch syndrome is to be followed closely by their doctor with regular colonoscopies, pelvic imaging (ultrasounds), urine tests, computerized tomography scans (CT scans), and skin examinations to watch for the development of cancer. Removal of the colon or uterus before cancer develops is also part of the usual approach. We are doing this study because we want to find out if the vaccines we are testing will be effective at preventing colon polyps and cancers of the colon and other organs.

The purpose of this study is to compare the safety and effects of the Tri-Ad5 vaccines alone, or in combination with N-803, versus placebo on the risk of developing colon and other cancers in patients with Lynch syndrome. The Tri-Ad5 vaccines and N-803 are not FDA-approved.

This study is looking for volunteers who have been diagnosed with Lynch syndrome. We will enroll 158 participants at institutions across the country.

This study is being done to answer the following question:

Can daratumumab-hyaluronidase reduce the level of MRD in T-ALL patients previously treated with chemotherapy?

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your T-ALL. The usual approach is defined as care most people get for Acute Lymphoblastic Leukemia (ALL). The usual approach for patients who are not in a study is treatment with chemotherapy, and possibly stem cell transplant. Sometimes, combinations of these treatments are used. Currently there is no SOC treatment for MRD positive T ALL. Many patients if eligible would undergo stem cell transplant, but still have a high risk for T ALL relapse if MRD positive

The purpose of this study is to test the good and bad effects of the drug called daratumumab and hyaluronidase. Daratumumab and hyaluronidase could be effective in preventing your cancer from returning, but it could also cause side effects. The study doctors hope to learn if the study drug will be effective in treating patients with MRD positive T-ALL and preventing reoccurrence of your disease.

The purpose of this study is to test any good and bad effects of the study drug called Libtayo(cemiplimab) in patients with the diagnosis of Cutaneous Squamous Cell Carcinoma (CSCC,) when given before resection surgery. This investigational approach could shrink your cancer, but it could also cause side effects. Researchers hope to learn if the use of this drug before surgery will reduce the amount of cancer cells by at least 50% compared to the original amount in more than 40% of patients. Libtayo (cemiplimab) is FDA-approved to treat metastatic CSCC.

Cemiplimab will be administered as an IV infusion over 30 minutes in an outpatient setting. Cemiplimab will be used at a flat 350 mg IV dose every 21 days for a total of 9 weeks (or 12 weeks). One cycle is 21 days. After discontinuation of treatment, if the tumor is potentially resectable, the patient will proceed with surgical resection.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete description of treatment.

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The STELLAR Program is a healthy lifestyle telehealth program designed for individuals who have been diagnosed with cancer, completed active treatment, and have 2 or 3 of the following health behaviors: 1) have a BMI of 25 or greater, 2) perform less than 90 minutes a week of moderate or vigorous physical activity, 3) currently smoke.

Our central mission is to increase the accessibility of equitable health support and resources for cancer survivors within Northwestern Medicine’s network. Spanning over the course of 12 months, trial participants are randomly assigned to one of two distinct study arms. One arm involves telehealth sessions with a health promotionist, fostering a close and supportive partnership between participants and health coaches across a sequence of 16 remote sessions. The second arm offers a self-guided avenue, empowering participants with personalized tools for self-paced progress.

This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a monoclonal antibody that is used to treat bone loss in order to reduce the risk of bone fractures in healthy people, and to reduce new bone growths in cancer patients whose cancer has spread to their bones. Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The goal of this protocol is to identify the potential for therapeutic efficacy of WP1066 plus RT in newly diagnosed patients with high-grade gliomas. WP 1066 blocks STAT3; STAT3 mediates regulatory signals and activates genes important to tumor-cell survival and proliferation, angiogenesis, evasion of cellular immune response, and metastasis.

This Phase II/III trial will evaluate what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase II trial tests whether ZEN003694 (ZEN-3694) in combination with talazoparib works to shrink tumors in patients with solid tumors that are unlikely to be cured or controlled with treatment and may have spread to other parts of the body. Another aim of this study is to determine if and how patients' genes influence their response to this specific drug combination. ZEN-3694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that overproduce BET protein. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. It is the accumulation of DNA damage which causes a cell to change into a cancerous cell. Combination therapy with ZEN-3694 and talazoparib may be effective at slowing or stopping tumor growth in patients with advanced cancer.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Colon and rectal cancer are cancers that involve the lowest part of the digestive system: the large intestine and the rectum. A colorectal cancer that has already spread to distant sites by the time it is diagnosed is referred to as metastatic (stage IV) colorectal cancer (CRC). In colorectal cancer, mutations in the BRAF gene are present in approximately 10% of patients with metastatic disease. Outcomes in these patients are poor relative to patients with non-BRAF mutated colon cancer. Encorafenib and cetuximab are standard of care therapy for metastatic colorectal cancer (CRC) patients who have disease progression (worsening of disease) after a previous line of therapy. Addition of hydroxychloroquine (HCQ) with encorafenib has shown to overcome the tumor’s resistance to encorafenib in laboratory studies. This study examines adding hydroxychloroquine to encorafenib and cetuximab in patients with worsening metastatic colon cancer on previous therapy. HCQ is an oral drug which is approved by the Food and Drug Administration (FDA) for other indications such as for treatment of uncomplicated malaria, preventive against malaria in select geographic regions, and for treatment of rheumatoid arthritis, systemic lupus erythematosus, and chronic discoid lupus erythematosus in adults. It is not currently FDA approved for the indication to be investigated in this study. As such, hydroxychloroquine will be the drug to be investigated (investigational drug) in this study in combination with encorafenib and cetuximab. Another drug named Panitumumab is also FDA approved for treatment of metastatic CRC in combination with other standard therapy. Panitumumab may also be used instead of Cetuximab in the above-mentioned treatment combination, depending on the choice of your doctor.

The primary objective is to estimate the Overall Response Rate (ORR) of treatment with CPI-613 plus HCQ and, depending on the cohort and indication, either 5-FU or gemcitabine.

Under this protocol, patients in cohorts 1 and 2 will be treated with combination of 2000 mg/m2 CPI-613 Day 1 and Day 15, plus 2400 mg/m2 Fluorouracil (5-FU) IV infusion over 46 hours Day 1 and Day 15, plus 400 mg hydroxychloroquine (HCQ) PO BID over 28-day cycles.

Patients in cohort 3 will be treated with combination of 2000 mg/m2 CPI-613 Day 1 and Day 15 plus 400 mg HCQ PO BID and, depending on indication, either 1000 mg/m2 gemcitabine or 2400 mg/m2 5-FU.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial

The study is being done to obtain evidence of effectiveness and safety for an imaging

and computer technology intended to assist your physician in prescribing the radiation

dose for your lung Stereotactic Body Radiotherapy (SBRT) treatment. The duration of radiotherapy is 1-2 weeks after you have been registered. You will be followed for up to 5 years to check if your cancer has come back after the radiotherapy.

This phase III trial compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase II/III trial compares the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) versus (vs.) usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (advanced) or has spread to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely deliver radiation to tumors with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin, pemetrexed, paclitaxel and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of radiation therapy to usual treatment may stop the cancer from growing and increase the life of patients with advanced non-small cell lung cancer who are PD-L1 negative.

This is a multi-center, open-label Phase 2 study designed to evaluate the efficacy and safety of BA3021 in PD-1/L1 failure patients with ROR-2 expression in recurrent or metastatic squamous cell carcinoma of the head and neck.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This study is being done to answer the following question: Can we lower the chance of pNET coming back by giving chemotherapy after surgery? We are doing this study because we want to find out if this approach is better or worse than the usual approach for patients that have had surgery for pNET. The usual approach is defined as care most people get after surgery for pNET.

If you decide to take part in this study, you will either get the study drugs capecitabine and temozolomide for up to four months or you will receive the usual approach of observation only. Observation means you will not receive treatment for pNET. After the first four months, your doctor will continue to follow your condition for 5 years, watch you for side effects, and see if your tumor comes back. During this time you will need to visit the clinic every 6 months for the first 3 years, then once every 12 months for 2 more years.

The purpose of this study is to collect and store tumor tissue samples and clinical data from participants with any type of sarcoma, obtained when participants undergo routine biopsy and/or surgery, for use in future research. Participants will be asked to allow for blood, tissue and archival tissue samples, and clinical data, to be used for this biorepository. Samples will only be collected during standard of care procedures. Additional blood will be requested at the time of standard of care labs. Leftover tissue will be requested from patients’ standard of care biopsy or surgery. Information related to cancer and its response to therapy, including pathology and radiology results, will be collected.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This is an open label Phase 1b/2 study to evaluate the efficacy and safety of ACR-368 as monotherapy or in combination with low dose gemcitabine in participants with platinum-resistant ovarian carcinoma, endometrial adenocarcinoma, and urothelial carcinoma based on Acrivon's OncoSignature® test status.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase I/Ib trial tests the safety and best dose of ipatasertib in combination with the usual treatment approach using chemotherapy together with radiation therapy ("chemo-radiation") in patients with stage III-IVB head and neck cancer. Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of tumor cells and may kill them. Cisplatin which is a chemotherapy used in this trial is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy to kill tumor cells and shrink tumors. Giving ipatasertib in combination with chemo-radiation may be better than chemo-radiation alone in treating patients with advanced head and neck cancer.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This is a first-in-human, open label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and the preliminary antitumor activity of BDTX-1535 in patients with GBM or NSCLC harboring sensitive EGFR alterations and who have disease progression following standard of care

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This study is being done to answer the following question: Which standard therapy is better for controlling your cancer for a longer period of time? We are doing this study because we want to find out which approach is better or worse for your advanced pancreatic neuroendocrine cancer. The usual approach is defined as care most people get for advanced pancreatic neuroendocrine cancer.

If you decide to take part in this study, you will either get lutetium Lu 177 dotatate, a radioactive drug given through your vein, for up to 8 months, or you will get the drugs temozolomide and capecitabine, as tablets you take by mouth, for up to 12 months.

After you finish your treatment, your doctor will continue to follow your condition at clinic visits and watch you for side effects. If you finish or choose to stop your treatment before your cancer gets worse, they will check on you every 3 months at clinic visits until your cancer gets worse or you start a different treatment. If your cancer gets worse or you start a different cancer treatment, they will check on you every 6 months by phone or medical record for a maximum of 8 years starting from the day you enrolled on the study.

The study is divided into 2 phases, a Safety Lead-In phase and a randomized perioperative phase. In the Safety Lead-In Phase, the recommended combination dose (RCD) of vorasidenib will be determined. In the Randomized Perioperative Phase, the Lymphocytes infiltration in tumors will be evaluated following pre-surgical treatment with vorasidenib and pembrolizumab combination, compared to untreated control tumors. Prior to surgery, participants will be randomized to receive vorasidenib at the RCD in combination with pembrolizumab, or vorasidenib only, or no treatment (untreated control group). Following surgery, participants will have the option to receive treatment with vorasidenib in combination with pembrolizumab in 21-day cycles.

Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met.

You are being asked to voluntarily take part in this clinical research study to test an oral drug, darolutamide, in addition to androgen deprivation therapy (ADT), because you have hormone sensitive high-risk biochemical recurrence (BCR) of prostate cancer (a type of cancer that is dependent on androgen hormones, such as testosterone). Testosterone helps prostate cancer to grow. So the most common way to control testosterone levels in the body is to block the gland that stimulates the testosterone production. High risk BCR refers to a stage of prostate cancer where the rise in Prostate Specific Antigen (PSA) levels to a certain threshold and within a specified period of time, during or following prostate cancer local therapies. This means that after local therapies with curative intent (surgery or radiotherapy) of prostate cancer, some cancer cells may have survived and are producing PSA. PSA is a protein that is produced by both cancerous and noncancerous prostate cells.

ADT is a systemic therapy called hormone therapy which reduces the androgen hormone (testosterone) levels to prevent prostate cancer cells from growing. ADT is frequently given with radiation therapy.

This study is being done to learn more about a new drug called darolutamide given in combination with ADT for your disease stage.

This phase II trial compares the effect of adding ipatasertib to pembrolizumab (standard immunotherapy) vs. pembrolizumab alone in treating patients with squamous cell cancer of the head and neck that has come back (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of tumor cells and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ipatasertib in combination with pembrolizumab may be more effective than pembrolizumab alone in improving some outcomes in patients with recurrent/metastatic squamous cell cancer of the head and neck.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This is a first-in-human, Phase I, open-label, multicenter study designed to evaluate the safety, tolerability and preliminary efficacy of WTX-124, a conditionally activated IL-2 prodrug, when administered as monotherapy and in combination with pembrolizumab, for the treatment of patients with advanced solid tumors. Part 1 of the study is dose escalation of WTX-124, both as monotherapy and in combination with pembrolizumab. Part 2 is comprised of four arms in which WTX-124 will be administered as monotherapy and in combination with pembrolizumab to patients with advanced or metastatic cutaneous malignant melanoma or advanced or metastatic renal cell carcinoma.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous (IV) administration of XmAb808 in combination with pembrolizumab in subjects with selected advanced solid tumors and to identify the minimum safe and biologically effective/recommended dose (RD) and schedule for XmAb808.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

As the number of available treatments for CTCL grow, there is a need to find a way to identify which treatment will work best for each subject. The goal of this study is to develop a test called a gene expression assay to see if the assay can predict treatment success and/or failure in subjects with CTCL.

This trial tests how well patient tailored physical activity interventions work to improve health and survival among older women with gynecologic cancers undergoing chemotherapy and other systemic therapies. Cancer therapy, as well as underlying cancer, cause accelerated aging and toxicity, leaving women vulnerable to functional decline, increased frailty, decreased health related quality of life, and ultimately, less systemic therapy completion and inferior cancer survival. Physical activity has been shown to improve functional health, improve quality of life, slow aging, and decrease rates of frailty. Engaging in patient tailored physical activity may safely and gradually increase physical activity in gynecologic cancer patients and lead to improved health and survival among older women with gynecologic cancers who are undergoing systemic treatment.

This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy.

This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in patients with advanced cancer that has recurred/progressed.

This study is being done to answer the following question: Can we increase the clinical complete response rate (tumor disappears by exam, endoscopy, and imaging) by adding a 3rd drug (irinotecan) to the standard regimen of FOLFOX or CAPOX given following long-course chemoradiation for patients with locally advanced rectal cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your rectal cancer. The usual approach is defined as care most people get for locally advanced rectal cancer.

A Phase 1 SAD/MAD dose escalation and expansion study to determine the safety and effectiveness of ²¹²Pb-DOTAM-GRPR1 in subjects with various GRPR-expressing Tumors

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

There are 2 parts to this study. The phase 1a portion (dose escalation) evaluates the safety and tolerability of NX-5948 in adult patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or Waldenströms macroglobulinemia (WM), who have received at least 2 prior systemic therapies (or at least 1 prior therapy for WM), and for whom no other therapies are known to provide clinical benefit.

The phase 1b portion (cohort expansion) investigates the efficacy of NX-5948 at the dose selected in Phase 1a in up to 5 cohorts of patients with R/R B-cell malignancies, who have received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM, primary central nervous system lymphoma (PCNSL), or secondary central nervous system involvement.

• Cohort A: CLL or SLL with disease progression after at least 2 prior systemic therapies
• Cohort B: CLL or SLL with disease progression after both a BTK inhibitor (BTKi) and BCL-2 inhibitor (may have been individually or in combination)
• Cohort C: MCL with disease progression on a BTKi and an anti-CD20 monoclonal antibody (mAb)-based regimen
• Cohort D: DLBCL with disease progression on an anthracycline and an anti-CD20 mAb-based regimen, or FL with disease progression on an anti-CD20 mAb-based regimen, or MZL with disease progression on an anti-CD20 mAb-based regimen, or WM with disease progression on a BTKi, or any of the indications listed in Cohorts A-D with CNS involvement, with disease progression on at least 1 prior therapy
• Cohort E: PCNSL with disease progression on at least 1 prior therapy

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors.

There are 7 parts to this study. In Parts A, B, C, and E, we’re testing different doses of tisotumab vedotin to see how it works to treat solid tumor cancers. Parts A, B, and C are no longer enrolling patients.

In Parts D, F, and G of the study, we want to learn more about how tisotumab vedotin works with some types of anti-cancer drugs. We’re testing tisotumab vedotin with pembrolizumab and carboplatin.

In Part D of the study, some patients with head and neck cancer could get tisotumab vedotin with pembrolizumab and cisplatin. Part D of the study is no longer enrolling patients.

In Part F of the study, we’re testing tisotumab vedotin with pembrolizumab to see if it works for head and neck cancers.

In Part G of the study, we will use the information we learn in Part F to keep studying tisotumab vedotin with carboplatin and pembrolizumab to see if it works for head and neck cancers.

In Part E of this study, we’re testing tisotumab vedotin in patients with head and neck cancer that came back or got worse after their last treatment.

Patients assigned to Group E will receive tisotumab vedotin once every 2 weeks for 4 weeks (28 day cycle)

If you’re in Part F, we’ll give you tisotumab vedotin once every 2 weeks and pembrolizumab once every 6 weeks.

If you’re in Part G, we’ll give you tisotumab vedotin and carboplatin once every 2 weeks and pembrolizumab every 6 weeks.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The purpose of this randomized Phase 3 study is to evaluate the efficacy, safety, and tolerability of epcoritamab 48 mg in combination with R 2 compared to R 2 alone in subjects with R/R FL.

The purpose of this study is to assess the safety and tolerability and determine the recommended Phase 2 dose of AIC100 Chimeric Antigen Receptor (CAR) T cells in patients with relapsed/refractory poorly differentiated thyroid cancer and anaplastic thyroid cancer.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This is a single-stage, phase 2 study of the combination of zanubrutinib, obinutuzumab, and venetoclax in previously untreated patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL), the latter including patients with evidence of TP53 mutation as well as transplant ineligible patients.

The primary aim of this study is to establish the rate of minimum residual disease (MRD) undetectable response in patients with CLL, to establish the 2-year progression free survival (PFS) in patients with TP53 mutated MCL, and to establish the 3-year PFS in transplant ineligible patients. Time to completion of study is estimated at 5 years.

The secondary objectives are to establish the recommended phase 2/3 duration of therapy, to determine the proportion of patients who successfully discontinue therapy after achieving an MRD undetectable response. Also, to determine the durability of clinical benefit after treatment discontinuation as measured by duration of peripheral blood MRD response and treatment-free survival. In addition, to determine whether induction therapy with 2 cycles of zanubrutinib and obinutuzumab prior to venetoclax reduces TLS risk assignment, and to assess safety and tolerability of the of zanubrutinib, obinutuzumab, and venetoclax regimen in the first-line setting. Finally, to assess safety and tolerability of the of zanubrutinib, obinutuzumab, and venetoclax regimen in the first-line setting.

The exploratory objectives are to cross validate MRD testing using multiparameter flow cytometry with DNA sequencing-based MRD assays in peripheral blood and bone marrow. To evaluate clonal evolution of CLL and MCL in serial patient samples on therapy with zanubrutinib, obinutuzumab, and venetoclax, during post-treatment surveillance, and at progression. To investigate the effects of zanubrutinib, obinutuzumab, and venetoclax on immune responses.

This study is being done to answer the following question: Is the chance of cancer spreading or returning the same if radiotherapy to the neck is guided, by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT), compared to the usual treatment when radiotherapy is given to both sides of the neck? This study will allow us to determine if this approach is better or worse in controlling cancer and has fewer side effects and better quality of life. The usual practice is the care most people get for your type of oropharyngeal cancer. Participants will either get 1) radiotherapy to cancer and both sides of the neck or 2) radiotherapy to cancer and neck based on Single Photon Emission Computed Tomography (SPECT/CT). The radiotherapy will be given in the usual way. Chemotherapy may be given in addition to radiotherapy as standard care.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This study is being done to answer the following question:

Will monitoring side effects in between clinic visits help women keep taking their hormone therapy medicine as prescribed for early-stage breast cancer?

We are doing this study because we want to find out if this approach is better or worse than the usual approach for helping women take their hormone therapy medicine. The usual approach is the follow-up care most people get after they are diagnosed with breast cancer and start hormone therapy.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This study will test the safety of a drug called SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.

This study will have 3 parts. Parts A and B of the study will find out how much SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if SGN-BB228 is safe and if it works to treat solid tumor cancers.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse free survival (RFS).

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This study is being done to test the orally administered study drug, CA-4948, either alone (monotherapy) or in combination (combination therapy) with an approved drug (azacitidine (AZA) or venetoclax (VEN)) in adult patients ages 18 and over diagnosed with Acute Myelogenous Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS).

The study drug is thought to work by blocking a protein in your body called interleukin-1 receptor-associated kinase 4 (IRAK4). IRAK4 plays an essential role in some of the signaling pathways that are frequently not controlled in AML/MDS. When these signals are not working properly, they can trigger cancer growth. By blocking IRAK4, the study drug may stop or reduce these signals and help fight your cancer

The purpose of this expanded access program (EAP) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications of CARVYKTI and is not available via the local health care system in the country where the treatment is requested.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.

This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The primary aim of this study is to assess the safety and efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) mycosis fungoides (MF). Subjects will be asked to use the imiquimod cream at designated lesions nightly for 5 consecutive days a week over 6 weeks. One week into the imiquimod treatment course, radiation therapy will be administered at Northwestern Medicine by radiation oncologists familiar with radiation treatment in 2 fractions of 4 Gy (units of radiation absorbed by the patient) (total 8 Gy) over 2 days to the same designated lesions. In addition, subjects will have two skin biopsies during the screening period and again at the same locations at week 8.

This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This ComboMATCH patient registration trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug called CalichDMH. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing them, stopping them from dividing, or spreading. Giving inotuzumab ozogamicin with chemotherapy may help shrink cancer and stop it from returning. The study subjects will either receive inotuzumab with lower doses of usual chemotherapy or get the usual chemotherapy treatment. In either treatment arm, study participants will receive two or more months (cycles) of more intensive chemotherapy. Both groups will continue with lower doses of chemotherapy for up to two years. Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Endometrial cancer is the most common gynecologic cancer and ovarian cancer is the most lethal. The management of both advanced cancers is a combination of chemotherapy and surgery. Standard of care chemotherapeutic treatment for uterine and ovarian cancers is toxic and severely disruptive to the patient's quality of life with the potential for devastating short and long-term side effects. The role of fasting and ketogenic diets has been evaluated in a mixed cancer population and previously shown to be safe. There is no data specifically addressing the impact of a fasting diet regimen on side effects of chemotherapy during treatment for ovarian and endometrial cancers in the front-line setting. The information gathered from this study will inform future trials about the role of time-restricted eating and its impact on side-effects associated with chemotherapy as well as its role in improvement of quality of life for women afflicted with these debilitating diseases.

The primary purpose of this testing is to determine the presence of 11 oncogenic drivers that can serve as targets for neoadjuvant therapies to be administered before surgery. The goal is to use this information from the screening process to select the optimal neoadjuvant therapy and wherever possible enroll patients onto separate but harmonized neoadjuvant therapy trials with genomically matched treatments or other appropriate trials if no driver is detected.

This phase II trial studies how well lutetium Lu 177 dotatate works in treating patients with prostate cancer with neuroendocrine differentiation (formed from cells that release hormones into the blood in response to a signal from the nervous system) that has spread to other places in the body (metastatic). Radioactive drugs, such as lutetium Lu 177, may carry radiation directly to tumor cells and not harm normal cells. The study aims to determine if this approach is better or worse than the usual approach for prostate cancer.

This phase II trial tests whether decitabine and cedazuridine (ASTX727) in combination with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow cancer in patients with chronic myelomonocytic leukemia, myelodysplastic syndrome /myeloproliferative neoplasm with excess blasts. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cobimetinib is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. The combination of ASTX727 and venetoclax may kill more cancer cells in patients with chronic myelomonocytic leukemia, myelodysplastic syndrome, or myeloproliferative neoplasm with excess blasts.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

HARMONIA is an international, multicenter, randomized, open-label and phase III study. The primary objective of this study is to demonstrate that the combination of ribociclib with endocrine therapy (letrozole or fulvestrant) is superior to palbociclib with endocrine therapy (letrozole or fulvestrant) in prolonging progression-free survival in patients with advanced HR+/HER2- and HER2-E breast cancer. The study will enroll approximately 456 patients with HER2-E disease from approximately 95 sites worldwide.

The aim of this study is to assess the safety, side effects

and effectiveness of EP0031 in patients with advanced

RET-altered malignancies

Note: This is only a partial description of the

study. Please contact the Robert H. Lurie

Comprehensive Cancer Center of

Northwestern University if you are interested

in the trial

The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD)

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial

This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer. PET and CT are imaging techniques that make detailed, computerized pictures of areas inside the body. The use of FDG-PET/CT may help doctors better decide if a patient needs more or less treatment before surgery in order to get the best response. This study evaluates whether FDG-PET/CT is useful in predicting a patient's response to standard of care chemotherapy.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase II trial compares the effect of adding triapine to lutetium Lu 177 dotatate versus lutetium Lu 177 dotatate alone (standard therapy) in shrinking tumors or slowing tumor growth in patients with neuroendocrine tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for deoxyribonucleic acid synthesis and cell growth. Lutetium Lu 177 dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177 dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radio-conjugate and a type of somatostatin analog. Giving triapine in combination with lutetium Lu 177 dotatate may be more effective at shrinking tumors or slowing tumor growth in patients with metastatic neuroendocrine tumors than the standard therapy of lutetium Lu 177 dotatate alone. Study participants will be assigned to receive lutetium Lu 177 dotatate alone or lutetium Lu 177 dotatate and triapine.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase II trial compares the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus in patients who have previously received 177Lu-DOTATATE for midgut neuroendocrine tumor (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and that cannot be removed by surgery (unresectable). PRRT is a type of radiation therapy for which a radioactive chemical is linked to a peptide (small protein) that targets cancer cells. When this radioactive peptide is injected into the body, it binds to a specific receptor found on some cancer cells. The radioactive peptide builds up in these cells and helps kill the cancer cells without harming normal cells. In this trial 177Lu-DOTATATE is used for PRRT. 177Lu-DOTATATE PRRT may increase the length of time until the midgut NET worsens compared to the usual approach. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping cancer cells from reproducing and by decreasing the blood supply to the cancer cells. Retreating with 177Lu-DOTATATE may work better than everolimus in shrinking or stabilizing tumor in patients with metastatic and unresectable NET who were previously treated with 177Lu-DOTATATE.

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trial that will compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This trial is a Phase II trial designed to evaluate the safety and efficacy of using oral AL8326 , a multi-targeted receptor Tyrosine Kinase Inhibitor( TKI) , to recurrent, advanced, or metastatic small cell lung cancer (SCLC) patients who need ≥2nd line treatment .

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This purpose of this trial is to shift the paradigm from chemotherapy to immunotherapy-based regimens and thereby reduce chemotherapy- related toxicities and improve clinical outcomes. We propose a phase II trial to assess the efficacy and safety of PET-directed PEM monotherapy for 6 cycles followed by abbreviated AVD therapy in newly diagnosed cHL, early unfavorable and advanced stages. We anticipate that six cycles of PEM upfront (three more cycles than in the NU 16H08 study) will increase the rate of complete metabolic response (CMR) to PEM monotherapy and allow the majority of patients to receive an abbreviated course of AVD chemotherapy with clinical outcomes similar to those seen in NU 16H08. We thereby anticipate shifting from chemotherapy-based strategies for cHL to predominantly immunotherapy, with the ultimate goal of eliminating chemotherapy altogether.

The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with select solid tumors who meet study enrollment criteria. The main questions it aims to answer are:

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial

In this study, a standard dose of radiation will be given to the majority of the tumor, while a simultaneously integrated boost of additional radiation will be given to certain areas of the tumor identified as higher risk. This means that a higher radiation dose will be given to the higher risk areas of the tumor.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This first-in-human (FIH) study will test the safety and side effects of a drug called XMT-1660. A side effect is anything a drug does to the body besides treating the disease.

Participants in the study will have cancer that has come back after a period of time during which the cancer could not be detected (recurrent), spread in the body near where it started(advanced) or spread through the body (metastatic).

The study will have two parts. The first part called Dose Escalation will find out how much XMT-1660 should be given toparticipants. The second part called Dose Expansion will use the dose found in the first part to find out how safe XMT-1660 is and if it works to treat solid tumor cancers.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Complion Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer and interfere with tumor cells' ability to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping, or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone. The study has three arms to which you could be randomly assigned: 1) atezolizumab, platinum drug, etoposide; 2) atezolizumab, platinum drug, etoposide, observation; 3) platinum drug, etoposide, observation.

This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to standard treatment (image guided radiation therapy [IGRT] and chemotherapy followed by immunotherapy with durvalumab) versus standard treatment alone in treating patients with non-small cell lung cancer that cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. IGRT is a type of radiation that uses a computer to create picture of the tumor, to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue. Standard chemotherapy used in this trial consists of combinations of the following drugs: cisplatin, carboplatin, paclitaxel, pemetrexed, and etoposide. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by blocking the action of a certain substance in the body that may help tumor cells multiply. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding SBRT to the standard treatment of IGRT with chemotherapy and immunotherapy may be more effective at treating patients with inoperable non-small cell lung cancer than giving the standard treatment alone.

Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype. Endocrine therapy is the mainstay of treatment; however, due to the varied nature of the disease, development of resistance to this therapeutic approach is very common in the metastatic setting.

The purpose of this study is to see whether the effectiveness of elacestrant can be enhanced by combining it with a targeted agent such as a CDK4/6 inhibitor to treat patients with ER+/HER2- or metastatic breast cancer with prior exposure to a CDK4/6 inhibitor.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.