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

Not Recruiting

Trial ID: NCT02105636

Age - 18 Years-N/A Condition - Head and Neck Cancers (H&N), H and N - Oral Cancer, H and N - Throat Cancer (Oropharynx, Laryngeal, Hypopharyngeal) Gender - All Accepting Healthy Volunteers - No

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
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
Heather Wakelee

Professor of Medicine (Oncology)

Joel Neal, MD, PhD
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

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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

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