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

November 2, 2012
October 13, 2014
December 2012
May 2015   (final data collection date for primary outcome measure)
  • 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
  • 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
Complete list of historical versions of study NCT01721746 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Unresectable or Metastatic Melanoma
  • Biological: BMS-936558
  • Drug: Dacarbazine
    Other Names:
    • DTIC-Dome
    • DTIC
  • Drug: Carboplatin
    Other Names:
    • Paraplatin
    • CBDCA
  • Drug: Paclitaxel
    Other Name: Onxol
  • 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
    Intervention: 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

    Interventions:
    • Drug: Dacarbazine
    • Drug: Carboplatin
    • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
390
January 2016
May 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Italy,   United Kingdom,   Switzerland,   Spain,   Netherlands,   Austria,   Belgium,   Brazil,   Denmark,   France,   Israel
 
NCT01721746
CA209-037, 2012-001828-35
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP