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A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy

Phase 3
18 Years
Open (Enrolling)
Unresectable or Metastatic Melanoma

Thank you

Trial Information

A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy

CheckMate 037: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 037

For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email Please visit 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

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (ORR) of BMS-936558 (Nivolumab) in subjects with advanced melanoma

Outcome Description:

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

Outcome Time Frame:

23 months

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


Austria : Federal Ministry for Labour, Health, and Social Affairs

Study ID:




Start Date:

December 2012

Completion Date:

May 2015

Related Keywords:

  • Unresectable or Metastatic Melanoma
  • Melanoma



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