Overview

This trial is active, not recruiting.

Condition melanoma
Treatments bms-936558 (nivolumab), placebo matching bms-936558 (nivolumab), dacarbazine, placebo matching dacarbazine
Phase phase 3
Sponsor Bristol-Myers Squibb
Start date January 2013
End date June 2014
Trial size 410 participants
Trial identifier NCT01721772, 2012‐003718‐16, CA209-066

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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
bms-936558 (nivolumab)
placebo matching dacarbazine
(Active Comparator)
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
placebo matching bms-936558 (nivolumab)
dacarbazine

Primary Outcomes

Measure
Endpoint of Overall survival (OS)
time frame: Up to 5 years

Secondary Outcomes

Measure
Progression-free survival (PFS)
time frame: Up to 5 years
Objective Response Rate (ORR)
time frame: Up to 5 years
Programmed death-ligand 1 (PD-L1) expression as predictive biomarker
time frame: Up to 5 years
Health Related Quality of Life (HRQoL)
time frame: Up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.