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 ClinicalTrials.gov)
DFCI Protocol ID: 14-107

 

The purpose of this study is to find out whether Nivolumab will significantly improve 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

Contacts:
Dana-Farber Cancer Institute: Patricia McHugh, RN, 617-632-3090, Patricia_McHugh@dfci.harvard.edu
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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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