Know Cancer

forgot password

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



Memorial Sloan Kettering Cancer Center New York, New York  10021
Roswell Park Cancer Institute Buffalo, New York  14263
Washington University School of Medicine Saint Louis, Missouri  63110
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Huntsman Cancer Institute Salt Lake City, Utah  84112
University Hospitals of Cleveland Cleveland, Ohio  44106
Winship Cancer Institute Atlanta, Georgia  30322
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Duke University Medical Center Durham, North Carolina  27710
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
Dana Farber Cancer Institute Boston, Massachusetts  02115
Mount Sinai Medical Center Miami Beach, Florida  33140
The Angeles Clinic & Research Institute Los Angeles, California  90404
UCSD Moores Cancer Center La Jolla, California  93093
Local Institution Phoenix, Arizona  
Local Institution Corona, California  
Local Institution Aurora, Colorado  
Yale University School Of Medicine New Haven, Connecticut  06520
Karmanos Cancer Institute Detroit, Michigan  48201
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
NYU Clinical Cancer Center New York, New York  10016
San Francisco Oncology Associates San Francisco, California  94115
UPMC Cancer Pavilion Pittsburgh, Pennsylvania  15232
University of Michigan Health System Ann Arbor, Michigan  
University of California - Los Angeles Los Angeles, California  90095
Levine Cancer Institute Charlotte, North Carolina  28211
Providence Oncology And Hematology Portland, Oregon  97213
St.Luke'S Cancer Center Easton, Pennsylvania  18045
Vanderbilt Univeresity Medical Center Nashville, Tennessee  37232