A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)

Completed · Phase 3

Conditions studied: Unresectable or Metastatic Melanoma

In brief

The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel

Key facts

Study ID

NCT01721746

Run by

Bristol-Myers Squibb

People needed

405

Starts

2012-12-21

Expected to finish

2020-12-29

Last updated by the study team

2022-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men \& women ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
• Histologically confirmed Stage III (unresectable)/Stage IV melanoma
• Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
• Objective evidence of disease progression (clinical or radiological) during or after at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment regimens
• Pre-treatment fresh core, excision or punch tumor biopsy
• Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available

You may not qualify if…

• Any treatment in a BMS-936558 (Nivolumab) trial
• Subjects with condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
• Active, known or suspected autoimmune disease
• Unknown BRAF status
• Active brain metastasis or leptomeningeal metastasis
• Ocular melanoma
• Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1 (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)

Where it is running

• UCSD Moores Cancer Center — La Jolla, California, United States
• The Angeles Clinic & Research Institute — Los Angeles, California, United States
• University Of California - Los Angeles — Los Angeles, California, United States
• San Francisco Oncology Associates — San Francciso, California, United States
• UCSF Comprehensive Cancer Center — San Francisco, California, United States
• University Of Colorado — Aurora, Colorado, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• Orlando Health, Inc — Orlando, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University Of Michigan Health System — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Allina Health — Minneapolis, Minnesota, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• NYU Clinical Cancer Center — New York, New York, United States
• MSKCC Clinical Laboratory at Nassau — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals — Cleveland, Ohio, United States
• Mayo Clinic — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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