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)
NCT ID: NCT01721746
Last Updated: 2022-04-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
405 participants
INTERVENTIONAL
2012-12-21
2020-12-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma
NCT01721772
An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
NCT03329846
A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)
NCT02156804
A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection
NCT03980314
Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
NCT02599402
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
BMS-936558
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
Dacarbazine
Carboplatin
Paclitaxel
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BMS-936558
Dacarbazine
Carboplatin
Paclitaxel
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic
Phoenix, Arizona, United States
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
Providence Oncology And Hematology
Portland, Oregon, United States
Network Office of Research and Innovation
Allentown, Pennsylvania, United States
St. Luke'S Health System
Allentown, Pennsylvania, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Local Institution
Innsbruck, , Austria
Local Institution
Vienna, , Austria
Local Institution
Brussels, , Belgium
Local Institution
Brussels, , Belgium
Local Institution
Edegem, , Belgium
Local Institution
Leuven, , Belgium
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Rio de Janeiro, , Brazil
Local Institution
São Paulo, , Brazil
Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
CHUM
Montreal, Quebec, Canada
Sir Mortimer B Davis - Jewish General Hospital
Montreal, Quebec, Canada
Aarhus Universitetshospital
Aarhus, , Denmark
Herlev Hospital
Herlev, , Denmark
Odense University Hospital
Odense, , Denmark
Local Institution
Clermont-Ferrand, , France
Local Institution
Lille, , France
Hopital La Timone
Marseille, , France
Local Institution
Nantes, , France
Local Institution
Nice, , France
Local Institution
Paris, , France
Local Institution
Pierre-Bénite, , France
Local Institution
Villejuif, , France
Local Institution
Würzburg, Bavaria, Germany
Local Institution
Buxtehude, , Germany
Local Institution
Dresden, , Germany
Local Institution
Essen, , Germany
Local Institution
Frankfurt am Main, , Germany
Local Institution
Hanover, , Germany
Local Institution
Heidelberg, , Germany
Local Institution
Kiel, , Germany
Local Institution
Lübeck, , Germany
Local Institution
Magdeburg, , Germany
Local Institution
Munich, , Germany
Local Institution
Tübingen, , Germany
Local Institution
Jerusalem, , Israel
Local Institution
Ramat Gan, , Israel
Local Institution
Bari, , Italy
Local Institution
Bergamo, , Italy
Local Institution
Genova, , Italy
Local Institution
Milan, , Italy
Local Institution
Milan, , Italy
Local Institution
Napoli, , Italy
Local Institution
Padua, , Italy
Local Institution
Roma, , Italy
Local Institution
Siena, , Italy
Local Institution
Amsterdam, , Netherlands
Local Institution
Groningen, , Netherlands
Local Institution
Maastricht, , Netherlands
Local Institution
Barcelona, , Spain
Local Institution
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Pamplona, , Spain
Local Institution
Valencia, , Spain
Local Institution
Lausanne, , Switzerland
Local Institution
Zurich, , Switzerland
Local Institution
Manchester, Greater Manchester, United Kingdom
Local Institution
Southampton, Hampshire, United Kingdom
Local Institution
Oxford, Oxfordshire, United Kingdom
Local Institution
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Local Institution
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Weber 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.
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-001828-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-037
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.