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)

• Status: Active, not recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Carboplatin; Dacarbazine; Nivolumab; Paclitaxel

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)