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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

This study is currently recruiting participants.
Verified April 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01721746
First received: November 2, 2012
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  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 III Trial of BMS-936558 Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Objective response rate (ORR) of BMS-936558 in subjects with advanced melanoma [ Time Frame: 23 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

  • Overall survival(OS) of BMS-936558 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: May 2015
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

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
  • RECIST defined disease progression during or after ≤ 2 prior treatment regimens
  • Pre-treatment fresh core or excision tumor biopsy.
  • Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available

Exclusion Criteria:

  • Any treatment in a BMS-936558 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721746

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Hide Study Locations
Locations
United States, California
Local Institution Not yet recruiting
La Jolla, California, United States, 92093
Contact: Site 0031            
The Angeles Clinic & Research Institute Recruiting
Los Angeles, California, United States, 90025
Contact: Omid Hamid, Site 0024     310-231-2183        
Ucla-Division Of Hematology/Oncology Recruiting
Los Angeles, California, United States, 90095-1678
Contact: Bartosz Chmielowski, Site 0029     310-794-3102        
Sutter West Bay Hospitals D/B/A Cal Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: David Minor, Site 0050     415-600-3027        
Local Institution Not yet recruiting
San Francisco, California, United States, 94115
Contact: Site 0019            
United States, Colorado
Local Institution Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Site 0018            
United States, Connecticut
Yale University School Of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Mario Sznol, Site 0034     203-737-5381        
United States, Florida
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Jose Lutzky, Site 0042     305-674-2625        
Md Anderson Cancer Center Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Gregory K Pennock, Site 0023     321-841-7303        
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Jeffrey Weber, Site 0016     813-745-4279        
United States, Georgia
Local Institution Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Site 0017            
United States, Illinois
Rush University Medical Center Terminated
Chicago, Illinois, United States, 60612
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: F. Stephen Hodi, Site 0020     617-632-6191        
United States, Michigan
Local Institution Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Site 0047            
Barbara Ann Karmanos Cancer Center Recruiting
Detroit, Michigan, United States, 48201-2014
Contact: Lawrence Flaherty, Site 0041     313-576-8394        
United States, Missouri
Washington University School Of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Gerald Linette, Site 0027     314-286-0227        
United States, New York
Local Institution Not yet recruiting
Buffalo, New York, United States, 14263
Contact: Site 0043            
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Sandra D'Angelo, Site 0028     646-888-4368        
Local Institution Not yet recruiting
New York, New York, United States, 10016
Contact: Site 0021            
United States, North Carolina
Local Institution Not yet recruiting
Charlotte, North Carolina, United States, 28204
Contact: Site 0014            
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: April Salama, Site 0035     919-684-2052        
United States, Ohio
Local Institution Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Site 0049            
United States, Oregon
Local Institution Not yet recruiting
Portland, Oregon, United States, 97213
Contact: Site 0033            
United States, Pennsylvania
St. Luke'S Hospital & Health Network Recruiting
Easton, Pennsylvania, United States, 18045
Contact: Sanjiv S. Agarwala, Site 0030     484-526-4363        
Local Institution Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Site 0048            
United States, Tennessee
Vanderbilt Univeresity Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Jeffrey Sosman, Site 0022     615-936-5867        
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Jeffrey Infante, Site 0025     615-329-7476        
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Kenneth Grossmann, Site 0015     801-589-4323        
Austria
Local Institution Not yet recruiting
Innsbruck, Austria, 6020
Contact: Site 0074            
Local Institution Not yet recruiting
Wien, Austria, 1090
Contact: Site 0073            
Belgium
Local Institution Completed
Brussels, Belgium, 1090
Local Institution Completed
Bruxelles, Belgium, 1200
Local Institution Completed
Edegem, Belgium, 2650
Local Institution Completed
Leuven, Belgium, 3000
Canada, Alberta
Local Institution Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 0062            
Canada, Quebec
Local Institution Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Site 0061            
Denmark
Local Institution Completed
Herlev, Denmark, 2730
Local Institution Completed
Odense, Denmark, 5000
France
Local Institution Terminated
Boulogne-billancourt, France, 92104
Local Institution Recruiting
Marseille, France, 13009
Contact: Site 0036            
Local Institution Recruiting
Nantes Cedex 1, France, 44093
Contact: Site 0039            
Local Institution Recruiting
Paris, France, 75475
Contact: Site 0038            
Local Institution Recruiting
Pierre Benite, France, 69495
Contact: Site 0040            
Local Institution Completed
Villejuif, France, 94805
Germany
Local Institution Not yet recruiting
Berlin, Germany, 12200
Contact: Site 0078            
Local Institution Not yet recruiting
Buxtehude, Germany, 21614
Contact: Site 0085            
Local Institution Not yet recruiting
Essen, Germany, 45122
Contact: Site 0072            
Local Institution Completed
Frankfurt Am Main, Germany, 60590
Local Institution Not yet recruiting
Hannover, Germany, 30625
Contact: Site 0077            
Local Institution Not yet recruiting
Heidelberg, Germany, 69120
Contact: Site 0069            
Local Institution Not yet recruiting
Kiel, Germany, 24105
Contact: Site 0070            
Local Institution Not yet recruiting
Munich, Germany, 81675
Contact: Site 0071            
Local Institution Not yet recruiting
Tubingen, Germany, 72076
Contact: Site 0068            
Italy
Local Institution Completed
Milano, Italy, 20133
Local Institution Completed
Siena, Italy, 53100
Spain
Local Institution Recruiting
Pamplona, Navarra, Spain, 31000
Contact: Site 0083            
Local Institution Recruiting
Barcelona, Spain, 08908
Contact: Site 0084            
Local Institution Not yet recruiting
Barcelona, Spain, 08036
Contact: Site 0080            
Local Institution Recruiting
Valencia, Spain, 46014
Contact: Site 0081            
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

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: April 3, 2013
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
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Dacarbazine
Carboplatin
Paclitaxel
 Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013