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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-908662 or Ipilimumab (A)

Group Type EXPERIMENTAL

BMS-908662

Intervention Type DRUG

Capsules, Oral, escalating doses starting at 25 mg, Q 12 h daily, Continuously

Ipilimumab

Intervention Type DRUG

Vial, IV, escalating doses starting at 3 mg/kg, Once every 3 weeks for 6 weeks, then once every 12 weeks, Continuously

BMS-908662 or Ipilimumab (B)

Group Type EXPERIMENTAL

BMS-908662

Intervention Type DRUG

Capsules, Oral, escalating doses starting at 25 mg Q 12 h daily for 3 weeks with 3 weeks interval for 4 cycles, then Q12 h daily for 3 weeks every 12 weeks, Continuously

Ipilimumab

Intervention Type DRUG

Vial, IV, escalating doses starting at 3 mg/kg, Once every 6 weeks for 4 cycles, then once every 12 weeks, Continuously

Interventions

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BMS-908662

Capsules, Oral, escalating doses starting at 25 mg, Q 12 h daily, Continuously

Intervention Type DRUG

BMS-908662

Capsules, Oral, escalating doses starting at 25 mg Q 12 h daily for 3 weeks with 3 weeks interval for 4 cycles, then Q12 h daily for 3 weeks every 12 weeks, Continuously

Intervention Type DRUG

Ipilimumab

Vial, IV, escalating doses starting at 3 mg/kg, Once every 3 weeks for 6 weeks, then once every 12 weeks, Continuously

Intervention Type DRUG

Ipilimumab

Vial, IV, escalating doses starting at 3 mg/kg, Once every 6 weeks for 4 cycles, then once every 12 weeks, Continuously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No