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An Open-Label, Randomized, Phase 2 Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma

Phase 2
18 Years
Open (Enrolling)
Advanced or Metastatic Melanoma

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Trial Information

An Open-Label, Randomized, Phase 2 Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma

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:

- Histologically confirmed unresectable Stage III or IV melanoma

- Treatment-naive or experienced disease recurrence or progression during or after one
prior systemic regimen for advanced disease

- Measurable disease by Computed Tomography/Magnetic resonance imaging (CT/MRI) per
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Known BRAF V600 mutation status or consent to BRAF V600 mutation testing

- Sufficient tumor tissue accessible for baseline and post-treatment biopsies.

Exclusion Criteria:

- Active central nervous system (CNS) metastases

- Carcinomatous meningitis

- Active, known or suspected autoimmune disease

- Condition requiring systemic treatment with either corticosteroids (>10 mg daily
prednisone equivalent) or other immunosuppressive medications within 14 days of

- Prior therapy with anti-Programmed Death-1 (PD1), anti-Programmed Death-Ligand 1
(PD-L1), anti-PD-L2, anti-CD137, or anti-CTLA-4 (cytotoxic T lymphocyte antigen 4)

- Prior treatment with other immunotherapies

- Prior therapy with BRAF inhibitor

Type of Study:


Study Design:

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

Outcome Measure:

Incidence of treatment-related grade 3-5 adverse events (AEs) during the induction period

Outcome Time Frame:

Up to Week 24

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

August 2014

Related Keywords:

  • Advanced or Metastatic Melanoma
  • Melanoma



Dana-Farber Cancer Institute Boston, Massachusetts  02115
University of Pennsylvania Philadelphia, Pennsylvania  19104
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
Dana Farber Cancer Institute Boston, Massachusetts  02115
Local Institution Indianapolis, Indiana  
Local Institution Corona, California  
Local Institution Arlington, Virginia  
Lehigh Valley Health Network Allentown, Pennsylvania  18103