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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)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: November 2, 2012
Last updated: January 5, 2017
Last verified: October 2016
The purpose of the study is to compare the response rate and overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel

Condition Intervention Phase
Unresectable or Metastatic Melanoma
Biological: BMS-936558
Drug: Dacarbazine
Drug: Carboplatin
Drug: Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Estimate the Objective Response Rate (ORR) in BMS-936558 (Nivolumab) treatment group [ Time Frame: 18 months ]
    ORR is defined as the number of subjects with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized subjects

  • Compare Overall Survival (OS) of BMS-936558 (Nivolumab) to investigator's choice in subjects with advanced melanoma [ Time Frame: 23 months ]
    Overall Survival (OS) is defined the time between the date of randomization to the date of death

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 23 months ]
    PFS is defined as the time from randomization to the date of the first documented progression or death due to any cause, whichever occurs first

  • Programmed death-ligand 1 (PD-L1) expression [ Time Frame: 23 months ]
    To evaluate whether PD-L1 expression is a predictive biomarker for ORR and OS by testing the interaction between PD-L1 expression and treatment arms

  • Health Related Quality of Life (HRQoL) [ Time Frame: Baseline (Day1) and 23 months ]
    HRQoL will be measured by mean changes from screening/baseline in the EORTC QLQ-C30 global health status/QoL composite scale and by mean changes from screening/baseline in the remaining EORTC QLQ-C30 scales in all randomized subjects

Estimated Enrollment: 390
Study Start Date: December 2012
Estimated Study Completion Date: September 2018
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-936558 3 mg/kg (IV)
BMS-936558 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: BMS-936558
Active Comparator: Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)

Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Drug: Dacarbazine
Other Names:
  • DTIC-Dome
  • DTIC
Drug: Carboplatin
Other Names:
  • Paraplatin
Drug: Paclitaxel
Other Name: Onxol


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

For more information regarding BMS clinical trial participation, please visit

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01721746

  Hide Study Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
Ucsd Moores Cancer Center
La Jolla, California, United States, 92093
The Angeles Clinic & Research Institute
Los Angeles, California, United States, 90025
University Of California - Los Angeles
Los Angeles, California, United States, 90095
San Francisco Oncology Associates
San Francisco, California, United States, 94115
Ucsf Comprehensive Cancer Center
SanFrancisco, California, United States, 94143
United States, Colorado
University Of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Orlando Health, Inc
Orlando, Florida, United States, 32806
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University Of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Allina Health
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Washington University School Of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Nyu Clinical Cancer Center
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals Of Cleveland
Cleveland, Ohio, United States, 44106
United States, Oregon
Providence Oncology And Hematology
Portland, Oregon, United States, 97213
United States, Pennsylvania
Network Office Of Research And Innovation
Allentown, Pennsylvania, United States, 18103
St.Luke'S Cancer Center
Easton, Pennsylvania, United States, 18045
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Local Institution
Innsbruck, Austria, 6020
Local Institution
Wien, Austria, A-1090
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Brussels, Belgium, 1090
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Bruxelles, Belgium, 1200
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Edegem, Belgium, 2650
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Leuven, Belgium, 3000
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Porto Alegre, Rio Grande do Sul, Brazil, 90035
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Rio de Janeiro, Brazil, 20220
Local Institution
Sao Paulo, Brazil, 01321
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Chum-Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Sir Mortimer B Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Aarhus Universitetshospital
Aarhus, Denmark, 8000
Herlev Hospital
Herlev, Denmark, 2730
Odense University Hospital
Odense, Denmark, 5000
Local Institution
Clermont Ferrand, France, 63003
Local Institution
Lille Cedex, France, 59037
Local Institution
Marseille, France, 13009
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Nantes Cedex 1, France, 44093
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Nice, France, 06200
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Paris, France, 75010
Local Institution
Pierre Benite, France, 69310
Local Institution
Villejuif, France, 94805
Local Institution
Wuerzburg, Bayern, Germany, 97080
Local Institution
Buxtehude, Germany, 21614
Local Institution
Dresden, Germany, 01307
Local Institution
Essen, Germany, 45122
Local Institution
Frankfurt Am Main, Germany, 60590
Local Institution
Hannover, Germany, 30449
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Heidelberg, Germany, 69120
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Kiel, Germany, D-24105
Local Institution
Luebeck, Germany, 23538
Local Institution
Magdeburg, Germany, 39120
Local Institution
Munich, Germany, 81675
Local Institution
Tubingen, Germany, 72076
Local Institution
Jerusalem, Israel, 91120
Local Institution
Ramat Gan, Israel, 52621
Local Institution
Bari, Italy, 70124
Local Institution
Bergamo, Italy, 24127
Local Institution
Genova, Italy, 16132
Local Institution
Milano, Italy, 20133
Local Institution
Milano, Italy, 20141
Local Institution
Napoli, Italy, 80131
Local Institution
Padova, Italy, 35128
Local Institution
Roma, Italy, 00144
Local Institution
Siena, Italy, 53100
Local Institution
Amsterdam, Netherlands, 1066 CX
Local Institution
Groningen, Netherlands, 9713 GZ
Local Institution
Maastricht, Netherlands, 6229 HX
Local Institution
Barcelona, Spain, 08036
Local Institution
Barcelona, Spain, 08908
Local Institution
Madrid, Spain, 28020
Local Institution
Madrid, Spain, 28041
Local Institution
Pamplona, Spain, 31192
Local Institution
Valencia, Spain, 46014
Local Institution
Lausanne, Switzerland, 1011
Local Institution
Zurich, Switzerland, 8091
United Kingdom
Local Institution
Manchester, Greater Manchester, United Kingdom, M20 4BX
Local Institution
Southampton, Hampshire, United Kingdom, SO16 6YD
Local Institution
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Local Institution
London, Surrey, United Kingdom, SW3 6JJ
Local Institution
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb Identifier: NCT01721746     History of Changes
Other Study ID Numbers: CA209-037  2012-001828-35 
Study First Received: November 2, 2012
Last Updated: January 5, 2017

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs processed this record on February 23, 2017