Study of BMS-936558 vs. Dacarbazine in Untreated, Unresectable or Metastatic Melanoma (CheckMate 066)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01721772
First received: November 2, 2012
Last updated: July 23, 2014
Last verified: April 2014

November 2, 2012
July 23, 2014
January 2013
September 2015   (final data collection date for primary outcome measure)
Endpoint of Overall survival (OS) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
OS is defined as the time between the date of randomization and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive
Same as current
Complete list of historical versions of study NCT01721772 on ClinicalTrials.gov Archive Site
  • Progression-free survival (PFS) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first
  • Objective Response Rate (ORR) [ Time Frame: Up to 5 years ] [ 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 for each treatment arm
  • Programmed death-ligand 1 (PD-L1) expression as predictive biomarker [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    PD-L1 expression as measured by the endpoint OS based on PD-L1 expression level
  • Health Related Quality of Life (HRQoL) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

    HRQoL as measured by mean changes from baseline in the EORTC-QLQ-C30 global health status/QoL composite scale and by mean changes from baseline in the remaining EORTC QLQ-C30 scales in all randomized subjects;

    EORTC-QLQ-C30 = European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Core 30

Same as current
Not Provided
Not Provided
 
Study of BMS-936558 vs. Dacarbazine in Untreated, Unresectable or Metastatic Melanoma (CheckMate 066)
A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

The purpose of this study is to compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Dacarbazine in subjects with previously untreated, unresectable or metastatic melanoma

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Melanoma
  • Biological: BMS-936558 (Nivolumab)
  • Biological: Placebo matching BMS-936558 (Nivolumab)
  • Drug: Dacarbazine
  • Drug: Placebo matching Dacarbazine
  • Experimental: Arm A: BMS-936558(Nivolumab) with Placebo matching Dacarbazine
    BMS-936558 (Nivolumab) 3 mg/kg Solution for injection, Intravenous (IV), Every 2 weeks with Placebo matching Dacarbazine 0mg/m² Solution for injection, IV, Every 3 weeks, Until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    Interventions:
    • Biological: BMS-936558 (Nivolumab)
    • Drug: Placebo matching Dacarbazine
  • Active Comparator: Arm B: Dacarbazine with Placebo matching BMS-936558(Nivolumab)
    Dacarbazine 1000mg/m² Solution for injection, IV, Every 3 weeks with Placebo matching BMS-936558 (Nivolumab) 0 mg/kg Solution for injection, Intravenous (IV), Every 2 weeks, Until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    Interventions:
    • Biological: Placebo matching BMS-936558 (Nivolumab)
    • Drug: Dacarbazine
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
410
November 2015
September 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 and women ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Untreated, histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system
  • Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
  • Known BRAF wild-type as per regionally acceptable V600 mutational status testing. BRAF mutant subjects and those with indeterminate or unknown BRAF status are not permitted to randomize

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases
  • Ocular melanoma
  • Any active, known or suspected autoimmune disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Canada,   Chile,   Denmark,   Finland,   France,   Germany,   Greece,   Israel,   Italy,   Mexico,   Norway,   Poland,   Spain,   Sweden
 
NCT01721772
CA209-066, 2012‐003718‐16
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2014

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