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

PHASE1TerminatedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

April 30, 2013

Study Completion Date

December 31, 2013

Conditions
Melanoma
Interventions
DRUG

Ipilimumab (BMS-734016)

Injection, intravenous (i.v.), cohort 1: 3 mg/kg, Escalate to cohort 2: 10 mg/kg, Escalate to cohort 3: at Recommended Phase 2 Dose (RP2D), De-escalate cohort 1A: 3 mg/kg, De-escalate cohort -1B: 10 mg/kg, (every three week) Q3wk, upto 2 yrs

DRUG

Vemurafenib

tablets, oral, cohort 1: 960 mg Twice daily (BID) x 28 days after date, cohort 2: 960 mg BID x 28 days after date, cohort 3: at Recommended Phase 2 Dose (RP2D) x 14 days after date, De-escalate cohort 1A: 720 mg BID x 28 days after date, De-escalate cohort -1B: 720 mg BID x 28 days after date , Up to 2 yrs

Trial Locations (4)

10065

Memorial Sloan-Kettering Cancer Center, New York

90095

University Of California Los Angeles, Los Angeles

02215

Dana Farber Cancer Institute, Boston

Dana Farber Cancer Inst, Boston

Sponsors
All Listed Sponsors
collaborator

Roche-Genentech

INDUSTRY

lead

Bristol-Myers Squibb

INDUSTRY