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)

• Objective response rate (ORR) of BMS-936558 (Nivolumab) 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 (Nivolumab) 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

• 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

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

CheckMate 037: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 037

• 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

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

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)