Ph I Ipilimumab Vemurafenib Combo in Patients With v-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)
NCT ID: NCT01400451
Last Updated: 2015-01-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
18 participants
INTERVENTIONAL
2011-11-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ipilimumab + Vemurafenib
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
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable Tumor
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
Exclusion Criteria
* Active Brain Metastasis (must be stable after radiation for at least one month)
* Prior therapy with immune stimulating agents
18 Years
ALL
No
Sponsors
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Roche-Genentech
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of California Los Angeles
Los Angeles, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Dana Farber Cancer Inst
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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References
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Ackerman A, Klein O, McDermott DF, Wang W, Ibrahim N, Lawrence DP, Gunturi A, Flaherty KT, Hodi FS, Kefford R, Menzies AM, Atkins MB, Long GV, Sullivan RJ. Outcomes of patients with metastatic melanoma treated with immunotherapy prior to or after BRAF inhibitors. Cancer. 2014 Jun 1;120(11):1695-701. doi: 10.1002/cncr.28620. Epub 2014 Feb 27.
Ludlow SP, Pasikhova Y. Cumulative dermatologic toxicity with ipilimumab and vemurafenib responsive to corticosteroids. Melanoma Res. 2013 Dec;23(6):496-7. doi: 10.1097/CMR.0000000000000018.
Mandala M, Voit C. Targeting BRAF in melanoma: biological and clinical challenges. Crit Rev Oncol Hematol. 2013 Sep;87(3):239-55. doi: 10.1016/j.critrevonc.2013.01.003. Epub 2013 Feb 15.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2011-000906-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA184-161 ST
Identifier Type: -
Identifier Source: org_study_id
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