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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 InstituteBoston, Massachusetts  02115
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Local InstitutionIndianapolis, Indiana  
Local InstitutionCorona, California  
Local InstitutionArlington, Virginia  
Lehigh Valley Health NetworkAllentown, Pennsylvania  18103