Clinical Trial Alliance A091201
- Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma
- Principal Investigator
- Sunandana Chandra
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.Alliance A091201
- The purpose of this study is to test whether the new treatment with an experimental drug, known as cabozantinib is more effective than chemotherapy for treating ocular melanoma.
- Cabozantinib may work by blocking a protein called MET which is often found to be an important cause of the growth and spread of ocular melanoma.
Some of the eligibility criteria include:
- Participants must have ocular melanoma that has spread beyond the eye and/or it cannot be removed with surgery.
- Prior treatment is allowed, with the exception of drugs that target specific cell receptors. Please discuss all prior treatments with the study doctor.
- Participants must be 18 or older.
- Description of Treatment
- Participants will be "randomized" into one of the study groups described below. Those in Group 1 (often called "Arm 1") will receive cabozantinib. Cabozantinib is taken by mouth every day of a 28-day cycle. Those in Group 2 (often called "Arm 2") will receive temozolomide (or dacarbazine if temozolomide is not available). Temozolomide is taken by mouth on days 1-5 of a 28 days cycle. If temozolomide is not available, dacarbazine may be given as a replacement. If this happens dacarbazine will be given by intravenous (IV) (through a needle or tube inserted into a vein) infusion on day 1 of a 21-day cycle.
- 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
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last updated: 25-Jul-16 01:10 AM
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