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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Melanoma

Treatments: Drug: Ipilimumab (BMS-734016); Drug: Vemurafenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01400451

2011-000906-22 (EudraCT Number)

CA184-161 ST

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Ipilimumab + Vemurafenib

Experimental group

Treatment:

Drug: Ipilimumab (BMS-734016)

Drug: Vemurafenib