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Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
Not Recruiting
Trial ID: NCT02105636
Purpose
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.
Official Title
An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Stanford Investigator(s)
A. Dimitrios Colevas, MD
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Heather Wakelee
Professor of Medicine (Oncology)
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
Eligibility
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,
squamous cell carcinoma of unknown primary, and salivary gland or non-squamous
histologies (eg: mucosal melanoma) are not allowed
- Subjects with active, known or suspected autoimmune disease
Intervention(s):
drug: Nivolumab
drug: Cetuximab
drug: Methotrexate
drug: Docetaxel
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061