Melanoma Clinical Trial

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

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Summary

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.

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Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT01400451

Recruitment Status:

Terminated

Sponsor:

Bristol-Myers Squibb

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There are 3 Locations for this study

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University Of California Los Angeles
Los Angeles California, 90095, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Dana Farber Cancer Inst
Boston Massachusetts, 02215, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT01400451

Recruitment Status:

Terminated

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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