A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Melanoma
Both
Melanoma
Trial Information
A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
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
- Recently acquired (within 90 days prior to randomization) 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 enroll
Exclusion Criteria:
- Active brain metastases or leptomeningeal metastases
- Ocular melanoma
- Any active, known or suspected autoimmune disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Endpoint of Overall survival (OS)
Outcome Description:
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
Outcome Time Frame:
Up to 5 years
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA209-066
NCT ID:
NCT01721772
Start Date:
January 2013
Completion Date:
June 2020
Related Keywords:
- Melanoma
- Melanoma
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