Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)

Status: Recruiting
Phase: Phase 3
Diagnosis: Head and Neck Cancer
NCT ID: NCT02105636 (View complete trial on
DFCI Protocol ID: 14-107


The purpose of this study is to find out whether Nivolumab will significantly improve progression-free survival and/or overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.


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

Overall PI:
Robert Haddad, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Elizabeth Buchbinder, MD, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Patricia McHugh, RN, 617-632-3090,
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit Inclusion Criteria: - Men and women ≥ 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 - Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) - Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting - Measurable disease by Computed tomography (CT) or Magnetic resonance imaging (MRI) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria Exclusion Criteria: - Active brain metastases or leptomeningeal metastases are not allowed - Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx and salivary gland or nonsquamous histologies - Subjects with active, known or suspected autoimmune disease
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