Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 064)

Status: Recruiting
Phase: Phase 2
Diagnosis: Cutaneous Skin Cancer
NCT ID: NCT01783938 (View complete trial on
DFCI Protocol ID:


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


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital

Overall PI:
Frank Stephen Hodi, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
David McDermott, MD, Beth Israel Deaconess Medical Center
Donald Lawrence, MD, Massachusetts General Hospital

Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Suzanne MacRae, 617-632-5906,
Dana-Farber Cancer Institute: Sarah Garcia, 617-632-2987,
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

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 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
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