Clinical Trial DRUG CA209025
- A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
- Principal Investigator
- Timothy Kuzel
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CA209025
- The purpose of this study is to compare the effectiveness of an experimental drug called BMS-936558 versus Everolimus in treating renal cell carcinoma.
- BMS-936558 is an investigational new drug that is believed to boost the immune system to help it recognize and attack cancer cells. It does this by blocking a specific protein in the body that can cause T-lymphocytes (cells of the immune system) to stop working. BMS-936558 has not been approved by the Federal Drug Administration (FDA). Everolimus is a FDA approved standard treatment.
Some of the eligibility criteria include:
- Participants must be 18 years or older.
- Participants must have advanced or metastatic clear cell renal cell cancer (it spread beyond the kidney).
- Participants must have received one or two prior anti-angiogenic therapy regimens (anti-angiogenic drug is one that controls the growth of blood vessels to the tumor, such as Bevacizumab). Please discuss all prior treatments with the study doctor.
- Description of Treatment
- Participants will be randomized (assigned by chance like flipping a coin) into one of two groups known as arms; Arm A or Arm B. Arm A will receive BMS-936558 and Arm B will receive Everolimus. Both Arms are on a 4-week (28 day) cycle of treatment.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
Find Related Clinical Trials
Browse by Disease Sites
Other Clinical Trials by Timothy Kuzel
- Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (mogamulizumab) Versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma
- A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
- A Phase Ib/II Trial of ALT-801 in Combination with Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer
- A Phase 1 Open-label Study of Safety and Tolerability of MEDI4736 in Subjects with Metastatic or Unresectable Melanoma in Combination with Dabrafenib and Trametinib or with Trametinib Alone
- A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma that has Progressed after Prior VEGFR Tyrosine Kinase Inhibitor Therapy
- A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma with Sarcomatoid Features
- A Phase II Trial of Dasatinib in Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Solar Melanomas
- Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy
- A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination with High Dose Interferon-a in Advanced Melanoma
- A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma
- A Randomized Phase II Study of Sequential Biotherapy with Aflibercept and High Dose IL-2 versus High Dose IL-2 alone in Patients with Inoperable Stage III or Stage IV Melanoma: Efficacy and Biomarker Study
- A Randomized Phase I Dose-Escalation Trial of Carfilzomib with and without Romidepsin in Cutaneous T-Cell Lymphoma
- Phase II Trial of Everolimus or Everolimus plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients with Advanced Urothelial Carcinoma (GU10-147)
- A Phase 1/2 study combining Ipilimumab with Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-Naïve Patients with Progressive Metastatic Castration-Resistant Prostate Cancer
last updated: 25-Apr-15 02:46 PM
Clinical trial availability changes frequently. Please check this site often for updates or call 312.695.1102 for personal assistance.