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)
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
2 other identifiers
interventional
405
14 countries
95
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2012
Longer than P75 for phase_3
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2012
CompletedFirst Posted
Study publicly available on registry
November 6, 2012
CompletedStudy Start
First participant enrolled
December 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2016
CompletedResults Posted
Study results publicly available
March 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2020
CompletedApril 19, 2022
March 1, 2022
3.2 years
November 2, 2012
February 1, 2017
March 23, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Objective Response Rate (ORR)
Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1
From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)
Overall Survival (OS)
Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.
Up to 96 months
Secondary Outcomes (5)
Progression Free Survival (PFS)
From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)
Objective Response Rate (ORR) by Baseline PD-L1 Expression
From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)
Overall Survival (OS) by PD-L1 Positive
Up to 96 months
Overall Survival (OS) by PD-L1 Negative
Up to 96 months
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
From Baseline (Day1) to second Follow-Up (Up to 96 months)
Study Arms (2)
BMS-936558 3 mg/kg (IV)
EXPERIMENTALBMS-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
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
ACTIVE COMPARATORDacarbazine: 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
Interventions
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (95)
Mayo Clinic
Phoenix, Arizona, 85054, United States
UCSD Moores Cancer Center
La Jolla, California, 92093, United States
The Angeles Clinic & Research Institute
Los Angeles, California, 90025, United States
University Of California - Los Angeles
Los Angeles, California, 90095, United States
San Francisco Oncology Associates
San Francciso, California, 94115, United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143, United States
University Of Colorado
Aurora, Colorado, 80045, United States
Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Orlando Health, Inc
Orlando, Florida, 32806, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University Of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Allina Health
Minneapolis, Minnesota, 55407, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
NYU Clinical Cancer Center
New York, New York, 10016, United States
MSKCC Clinical Laboratory at Nassau
New York, New York, 10065, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University Hospitals
Cleveland, Ohio, 44106, United States
Providence Oncology And Hematology
Portland, Oregon, 97213, United States
Network Office of Research and Innovation
Allentown, Pennsylvania, 18103, United States
St. Luke'S Health System
Allentown, Pennsylvania, 18109, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Local Institution
Innsbruck, 6020, Austria
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Vienna, A-1090, Austria
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Edegem, 2650, Belgium
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Leuven, 3000, Belgium
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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
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Rio de Janeiro, 20220-410, Brazil
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São Paulo, 01321-001, Brazil
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CHUM
Montreal, Quebec, H2X 3E4, Canada
Sir Mortimer B Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Aarhus Universitetshospital
Aarhus, 8000, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Odense University Hospital
Odense, 5000, Denmark
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Clermont-Ferrand, 63003, France
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Lille, 59037, France
Hopital La Timone
Marseille, 13009, France
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Nantes, 44093, France
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Nice, 06200, France
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Paris, 75010, France
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Pierre-Bénite, 69310, France
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Villejuif, 94805, France
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Würzburg, Bavaria, 97080, Germany
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Buxtehude, 21614, Germany
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Dresden, 01307, Germany
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Essen, 45122, Germany
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Frankfurt am Main, 60590, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Kiel, D-24105, Germany
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Lübeck, 23538, Germany
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Magdeburg, 39120, Germany
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Munich, 81675, Germany
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Tübingen, 72076, Germany
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Jerusalem, 91120, Israel
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Ramat Gan, 52621, Israel
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Bari, 70124, Italy
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Bergamo, 24127, Italy
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Genova, 16132, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Roma, 00144, Italy
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Siena, 53100, Italy
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Amsterdam, 1066 CX, Netherlands
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Groningen, 9713 GZ, Netherlands
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Maastricht, 6229 HX, Netherlands
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Barcelona, 08036, Spain
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Barcelona, 08908, Spain
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Madrid, 28020, Spain
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Madrid, 28041, Spain
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Pamplona, 31192, Spain
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Valencia, 46014, Spain
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Lausanne, 1011, Switzerland
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Zurich, 8091, Switzerland
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Manchester, Greater Manchester, M20 4BX, United Kingdom
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Southampton, Hampshire, SO16 6YD, United Kingdom
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Oxford, Oxfordshire, OX3 7LJ, United Kingdom
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Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
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London, SW3 6JJ, United Kingdom
Related Publications (2)
Larkin J, Minor D, D'Angelo S, Neyns B, Smylie M, Miller WH Jr, Gutzmer R, Linette G, Chmielowski B, Lao CD, Lorigan P, Grossmann K, Hassel JC, Sznol M, Daud A, Sosman J, Khushalani N, Schadendorf D, Hoeller C, Walker D, Kong G, Horak C, Weber J. Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator's Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial. J Clin Oncol. 2018 Feb 1;36(4):383-390. doi: 10.1200/JCO.2016.71.8023. Epub 2017 Jul 3.
PMID: 28671856DERIVEDWeber JS, D'Angelo SP, Minor D, Hodi FS, Gutzmer R, Neyns B, Hoeller C, Khushalani NI, Miller WH Jr, Lao CD, Linette GP, Thomas L, Lorigan P, Grossmann KF, Hassel JC, Maio M, Sznol M, Ascierto PA, Mohr P, Chmielowski B, Bryce A, Svane IM, Grob JJ, Krackhardt AM, Horak C, Lambert A, Yang AS, Larkin J. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):375-84. doi: 10.1016/S1470-2045(15)70076-8. Epub 2015 Mar 18.
PMID: 25795410DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2012
First Posted
November 6, 2012
Study Start
December 21, 2012
Primary Completion
February 16, 2016
Study Completion
December 29, 2020
Last Updated
April 19, 2022
Results First Posted
March 22, 2017
Record last verified: 2022-03