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Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma

A Single Arm Open-Label Phase II Study of Vemurafenib Followed by Ipilimumab in Subjects With Previously Untreated V600 BRAF Mutated Advanced Melanoma

NCT01673854•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety profile of vemurafenib, 960 mg, administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600 mutated advanced/metastatic melanoma.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
•Men and women 18 years of age and older
•Histologic diagnosis of malignant melanoma tested positive for the BRAF V600 mutation
•Previously untreated unresectable Stage III or Stage IV melanoma
•Complete set of brain/neck, chest, abdomen/pelvis axial radiographs taken within 28 days of first dose of study drug
•Measurable melanoma by physical or radiographic examination
•Brain metastases stable after radiation for at least 1 month and off corticosteroid therapy for ≥30 days prior to enrollment
•Eastern Cooperative Oncology Group performance status of 0 or 1
•Adequate hematologic parameters and renal and hepatic function

Exclusion Criteria

•Primary ocular melanoma
•Active brain metastases with symptoms or requiring corticosteroid treatment
•Any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
•History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies
•History of or current immunodeficiency disease, splenectomy, or splenic irradiation
•Prior anticancer therapy or investigational products \<4 weeks prior to enrollment
•Prior therapy with a BRAF or MEK inhibitor and prior investigational anticancer immunotherapies;
•Prior therapies with immunosuppressive agents within the past 2 years
•Concomitant therapy with any anticancer or potent immunosuppressive agent, surgery, radiotherapy, other investigational anticancer therapies, or chronic use of systemic corticosteroids

Locations (14)

Beverly Hills Cancer Center

Beverly Hills, California, United States

Baptist Cancer Institute

Jacksonville, Florida, United States

Orlando Health, Inc

Orlando, Florida, United States

Winship Cancer Institute

Atlanta, Georgia, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

University Of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Mount Sinai School Of Medicine

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Key Dates

Start Date

September 13, 2012

Primary Completion Date

July 25, 2014

Completion Date

May 12, 2015

Last Updated

July 24, 2018

Enrollment

ACTUAL participants

Conditions

Melanoma

Interventions

Ipilimumab

DRUG

Vemurafenib

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma

Inclusion Criteria

Exclusion Criteria

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