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.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01721746
First received: November 2, 2012
Last updated: October 13, 2014
Last verified: August 2014
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: January 2016
Estimated Primary Completion Date: May 2015 (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
  • CBDCA
Drug: Paclitaxel
Other Name: Onxol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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 ClinicalTrials.gov identifier: NCT01721746

  Hide Study Locations
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
San Francisco, California, United States, 94115
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
Md Anderson Cancer Center Orlando
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
St. 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
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Austria
Local Institution
Innsbruck, Austria, 6020
Local Institution
Wien, Austria, A-1090
Belgium
Local Institution
Brussels, Belgium, 1090
Local Institution
Bruxelles, Belgium, 1200
Local Institution
Edegem, Belgium, 2650
Local Institution
Leuven, Belgium, 3000
Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil, 90035
Local Institution
Rio de Janeiro, Brazil, 20220
Local Institution
Sao Paulo, Brazil, 01323
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Chum, Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Denmark
Local Institution
Aarhus, Denmark, 8000
Local Institution
Herlev, Denmark, 2730
Local Institution
Odense, Denmark, 5000
France
Local Institution
Clermont Ferrand, France, 63003
Local Institution
Lille Cedex, France, 59037
Local Institution
Marseille, France, 13009
Local Institution
Nantes Cedex 1, France, 44093
Local Institution
Nice, France, 06200
Local Institution
Paris, France, 75010
Local Institution
Pierre Benite, France, 69495
Local Institution
Villejuif, France, 94805
Germany
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
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
Israel
Local Institution
Jerusalem, Israel, 71908
Local Institution
Ramat Gan, Israel, 52621
Italy
Local Institution
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
Netherlands
Local Institution
Amsterdam, Netherlands, 1066 CX
Local Institution
Groningen, Netherlands, 9713 GZ
Local Institution
Maastricht, Netherlands, 6229 HX
Spain
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
Switzerland
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
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01721746     History of Changes
Other Study ID Numbers: CA209-037, 2012-001828-35
Study First Received: November 2, 2012
Last Updated: October 13, 2014
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Brazil: National Health Surveillance Agency
Canada: Health Canada
Denmark: Danish Dataprotection Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Spanish Agency of Medicines
Switzerland: Federal Office of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014