Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064)

Completed · Phase 2

Conditions studied: Advanced or Metastatic Melanoma

In brief

The purpose of this study is to evaluate the safety and efficacy of a sequential combination therapy of Nivolumab and Ipilimumab

Key facts

Study ID

NCT01783938

Run by

Bristol-Myers Squibb

People needed

138

Starts

2013-04-30

Expected to finish

2020-08-12

Last updated by the study team

2021-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 randomization
• 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) antibody
• Prior treatment with other immunotherapies
• Prior therapy with BRAF inhibitor within 6 weeks of enrollment

Where it is running

• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Indiana University Health Melvin And Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• University Of Pennsylvania — Philadelphia, Pennsylvania, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• University Of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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