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)
- Conditions
- Unresectable or Metastatic Melanoma
- Interventions
- Registration Number
- NCT01721746
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 405
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-936558 3 mg/kg (IV) BMS-936558 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 Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel) Dacarbazine 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 Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel) Carboplatin 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 Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel) 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
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to 96 months Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.
Objective Response Rate (ORR) From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months) Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months) Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.
Objective Response Rate (ORR) by Baseline PD-L1 Expression From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months) Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.
Overall Survival (OS) by PD-L1 Positive Up to 96 months Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Mean Change From Baseline in Health-related Quality of Life (HRQoL) From Baseline (Day1) to second Follow-Up (Up to 96 months) Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric.
Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline.
A 10 point difference on a 100 point scale between treatments was considered clinically significant.Overall Survival (OS) by PD-L1 Negative Up to 96 months Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Trial Locations
- Locations (41)
Mayo Clinic
🇺🇸Phoenix, Arizona, United States
UCSD Moores Cancer Center
🇺🇸La Jolla, California, United States
The Angeles Clinic & Research Institute
🇺🇸Los Angeles, California, United States
University Of California - Los Angeles
🇺🇸Los Angeles, California, United States
San Francisco Oncology Associates
🇺🇸San Francciso, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
University Of Colorado
🇺🇸Aurora, Colorado, United States
Yale University School Of Medicine
🇺🇸New Haven, Connecticut, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Orlando Health, Inc
🇺🇸Orlando, Florida, United States
Scroll for more (31 remaining)Mayo Clinic🇺🇸Phoenix, Arizona, United States