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)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Unresectable or Metastatic Melanoma

Treatments: Drug: Dacarbazine; Drug: Carboplatin; Drug: Paclitaxel; Biological: BMS-936558

Study type: Interventional

Funder types: Industry

Identifiers

NCT01721746

CA209-037

2012-001828-35 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 405 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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405 participants in 2 patient groups

BMS-936558 3 mg/kg (IV)

Experimental group

Description:

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

Treatment:

Biological: BMS-936558

Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)

Active Comparator group

Description:

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

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: Dacarbazine