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)

March 23, 2022 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

405

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Local Institution
      • Wien, Austria, A-1090
        • Local Institution
  • Belgium
      • Brussels, Belgium, 1090
        • Local Institution
      • Bruxelles, Belgium, 1200
        • Local Institution
      • Edegem, Belgium, 2650
        • Local Institution
      • Leuven, Belgium, 3000
        • Local Institution
  • Brazil
      • Rio de Janeiro, Brazil, 20220-410
        • Local Institution
      • Sao Paulo, Brazil, 01321-001
        • Local Institution
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
        • Local Institution
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM
      • Montreal, Quebec, Canada, H3T 1E2
        • Sir Mortimer B Davis - Jewish General Hospital
  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus Universitetshospital
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital
  • France
      • Clermont Ferrand, France, 63003
        • Local Institution
      • Lille Cedex, France, 59037
        • Local Institution
      • Marseille, France, 13009
        • Hôpital La Timone
      • Nantes Cedex 01, France, 44093
        • Local Institution
      • Nice, France, 06200
        • Local Institution
      • Paris, France, 75010
        • Local Institution
      • Pierre Benite, France, 69310
        • Local Institution
      • Villejuif, France, 94805
        • Local Institution
  • Germany
      • Buxtehude, Germany, 21614
        • Local Institution
      • Dresden, Germany, 01307
        • Local Institution
      • Essen, Germany, 45122
        • Local Institution
      • Frankfurt am Main, Germany, 60590
        • Local Institution
      • Hannover, Germany, 30625
        • Local Institution
      • Heidelberg, Germany, 69120
        • Local Institution
      • 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
    • Bayern
      • Wuerzburg, Bayern, Germany, 97080
        • Local Institution
  • Israel
      • Jerusalem, Israel, 91120
        • Local Institution
      • Ramat Gan, Israel, 52621
        • Local Institution
  • Italy
      • Bari, Italy, 70124
        • Local Institution
      • Bergamo, Italy, 24127
        • Local Institution
      • Genova, Italy, 16132
        • Local Institution
      • Milano, Italy, 20141
        • Local Institution
      • Milano, Italy, 20133
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Padova, Italy, 35128
        • Local Institution
      • Roma, Italy, 00144
        • Local Institution
      • Siena, Italy, 53100
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution
      • Groningen, Netherlands, 9713 GZ
        • Local Institution
      • Maastricht, Netherlands, 6229 HX
        • Local Institution
  • Spain
      • Barcelona, Spain, 08036
        • Local Institution
      • Barcelona, Spain, 08908
        • Local Institution
      • Madrid, Spain, 28041
        • Local Institution
      • Madrid, Spain, 28020
        • Local Institution
      • Pamplona, Spain, 31192
        • Local Institution
      • Valencia, Spain, 46014
        • Local Institution
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Local Institution
      • Zuerich, Switzerland, 8091
        • Local Institution
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Local Institution
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Local Institution
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Local Institution
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
        • Local Institution
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
        • Local Institution
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
    • California
      • La Jolla, California, United States, 92093
        • UCSD Moores Cancer Center
      • Los Angeles, California, United States, 90095
        • University of California - Los Angeles
      • Los Angeles, California, United States, 90025
        • The Angeles Clinic & Research Institute
      • San Francciso, California, United States, 94115
        • San Francisco Oncology Associates
      • San Francisco, California, United States, 94143
        • UCSF Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
      • Orlando, Florida, United States, 32806
        • Orlando Health, Inc
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Allina Health
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10016
        • NYU Clinical Cancer Center
      • New York, New York, United States, 10065
        • MSKCC Clinical Laboratory at Nassau
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Oncology And Hematology
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Network Office of Research and Innovation
      • Allentown, Pennsylvania, United States, 18109
        • St. Luke's Health System
      • Pittsburgh, Pennsylvania, United States, 15232
        • Hillman Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Carboplatin
Other Names:
  • CBDCA
  • Paraplatin
Drug: Paclitaxel
Other Names:
  • Onxol
Drug: Dacarbazine
Other Names:
  • DTIC
  • DTIC-Dome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 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)
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)
Time Frame: Up to 96 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.
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
Time Frame: From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)
Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.
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
Time Frame: Up to 96 months
Overall Survival (OS) by PD-L1 expression 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.
Up to 96 months
Overall Survival (OS) by PD-L1 Negative
Time Frame: Up to 96 months
Overall Survival (OS) by PD-L1 expression 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.
Up to 96 months
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Time Frame: From Baseline (Day1) to second Follow-Up (Up to 96 months)

Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric.

Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline.

A 10 point difference on a 100 point scale between treatments was considered clinically significant.
From Baseline (Day1) to second Follow-Up (Up to 96 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2012

Primary Completion (Actual)

February 16, 2016

Study Completion (Actual)

December 29, 2020

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

November 2, 2012

First Posted (Estimate)

November 6, 2012

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-037
  • 2012-001828-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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