Ph I Ipilimumab Vemurafenib Combo in Patients With v-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)

Stopped early · Phase 1

Conditions studied: Melanoma

In brief

Treatment of subjects who have metastatic melanoma that expresses an activated mutant form of the BRAF oncogene (V600E) with a combination of the specific BRAF inhibitor, Vemurafenib, and the Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) inhibitor mAb Ipilimumab will be safe and feasible and will show preliminary evidence of anti-tumor efficacy and survival in comparison to historical results following treatment with either agent alone.

Key facts

Study ID

NCT01400451

Run by

Bristol-Myers Squibb

People needed

18

Starts

2011-11-01

Expected to finish

2013-12-01

Last updated by the study team

2015-01-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Metastatic melanoma with activating V600 BRAF mutation
• Measurable Tumor
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

You may not qualify if…

• Autoimmune disease
• Active Brain Metastasis (must be stable after radiation for at least one month)
• Prior therapy with immune stimulating agents

Where it is running

• University Of California Los Angeles — Los Angeles, California, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Dana Farber Cancer Inst — Boston, Massachusetts, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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