Ph I/II Ipilimumab Vemurafenib Combo



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:November 2011
End Date:August 2015
Contact:For participation information at a USA site use a phone number below. For site information outside the USA please email:
Email:Clinical.Trials@bms.com

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A Phase I/II Trial of Vemurafenib and Ipilimumab in Subjects With V600 BRAF Mutation-positive Metastatic Melanoma


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.


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
We found this trial at
3
sites
Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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1275 York Avenue
New York, New York 10065
212-639-2000
Memorial Sloan-Kettering Cancer Center Memorial Sloan-Kettering Cancer Center — the world's oldest and largest private...
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from
New York, NY
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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from
Boston, MA
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