Protocol
11-148
Full Title
A Phase I/II Trial of Vemurafenib (RG7204) and Ipilimumab in Subjects with V600 BRAF Mutation-Positive Metastatic Melanoma
Purpose
Vemurafenib and ipilimumab are drugs that are both approved for treating melanoma. Vemurafenib works by inhibiting the activity of BRAF, a protein which, when mutated, drives the growth of metastatic melanoma. Vemurafenib is approved specifically for patients with a BRAF mutation called V600.
Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. One way cancers can escape the immune system could be through this shut-down mechanism. Ipilimumab is an antibody against CTLA-4 and stops it from turning off the immune system, allowing an immune reaction to continue. This immune reaction may help the body to destroy cancer cells.
The use of vemurafenib and ipilimumab together is considered investigational. The purpose of the phase I portion of this study is to find the highest dose of these two drugs that can be given together safely in patients with metastatic melanoma. The phase II portion will assess the effectiveness of this treatment.
Investigator
Wolchok, Jedd, MD, PhD
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients participating in the phase I portion of the study must have metastatic melanoma which was either previously treated and returned, or is previously untreated. Only patients with previously untreated metastatic melanoma may participate in the phase II portion.
- Patients tumors must contain the V600 BRAF mutation.
- Patients may not have previously been treated with a BRAF inhibitor or anti-CTLA4 drugs.
- At least 2 weeks must have passed since major surgery and 4 weeks since completion of prior chemotherapy and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Jedd Wolchok at 646-888-2395.
Disease(s)
Advanced Cancer
Melanoma
