Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Melanoma

Treatments: Drug: Ipilimumab; Drug: BMS-908662

Study type: Interventional

Funder types: Industry

Identifiers

NCT01245556

CA206-005

Details and patient eligibility

About

The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with ipilimumab; and then to evaluate the anti-tumor response to BMS-908662 when administered in combination with ipilimumab.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Male and female subjects ≥ 18 years of age with a histologic or cytologic diagnosis of Stage III or Stage IV (unresectable) melanoma
• Enrollment to cohort expansion will be limited to only those subjects whose tumors demonstrate the B-Raf V600E mutation
• ECOG ≤ 1
• Adequate organ & marrow function

Exclusion:

• Uncontrolled or significant cardiovascular disease
• Cohort expansion: Prior therapy with a RAF inhibitor

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

BMS-908662 or Ipilimumab (A)

Experimental group

Treatment:

Drug: Ipilimumab

Drug: BMS-908662

Drug: BMS-908662

Drug: Ipilimumab

BMS-908662 or Ipilimumab (B)

Experimental group

Treatment:

Drug: Ipilimumab

Drug: BMS-908662

Drug: BMS-908662

Drug: Ipilimumab