Clinical Trial DRUG CD-ON-MEDI4736-1161
- 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
- Principal Investigator
- Sunandana Chandra
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CD-ON-MEDI4736-1161
- The main purpose of this study is to determine the highest dose of MEDI4736 in combination with dabrafenib and trametinib or trametinib alone that is tolerable (does not cause harmful side effects) in research participants with metastatic or unresectable melanoma. The other main purpose of this study is study the safety of MEDI4736 in combination with dabrafenib and trametinib or trametinib alone.
- Participants in this study have a type of skin cancer (or tumor) called metastatic (cancer that spreads from one part of the body to another) or unresectable (unable to be removed with surgery) melanoma. The most common mutation (change) in melanoma occurs in a gene called BRAF, which is present in cancer cells. A mutation is a change that occurs in a gene. A gene is a piece of hereditary (inherited) material (i.e. DNA) contained in cells. BRAF-mutation positive (presence of the mutation in BRAF) and BRAF wild-type (no sign of this mutation) are 2 forms of melanoma. The study population will include research participants with metastatic or unresectable melanoma who have either BRAF-mutation positive or BRAF wild-type melanoma. MEDI4736 is an antibody that is made in the lab. An antibody is a natural protein made by the immune system that binds other proteins and molecules to fight infection and its ill effects. MEDI4736 is an experimental drug being tested in humans. MEDI4736 binds to another protein in the body and may prevent cancer growth by helping certain blood cells of the immune system eliminate the tumor. Two other drugs, dabrafenib and trametinib, will also be used in this study. Dabrafenib and trametinib are both approved by the US FDA and Health Canada, and dabrafenib has also been approved by the European Commission for treatment of certain types of metastatic melanoma. The use of these drugs in combination with MEDI4736 is experimental.
Some of the eligibility criteria include:
- Participants must have metastatic or unresectable melanoma.
- Participants must be 18 or older.
- Some prior treatments are not allowed (e.g., other BRAF or MEK inhibitors). Please discuss all prior treatments with the study doctor.
- Description of Treatment
- Participants in this study will be assigned to one of three treatment groups, based on their specific melanoma. Group A (for participants with BRAF-mutation positive melanoma) is a combination of MEDI4736 with dabrafenib and trametinib. Groups B and C (for participants with BRAF wild-type melanoma) will explore a combination of MEDI4736 with trametinib in two different schedules.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Randomized Phase III trial of Dabrafenib + Trametinib followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma
- Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV melanoma
last updated: 01-Jul-16 08:31 AM
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