Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Bristol-Myers Squibb

Collaborator: Ono Pharmaceutical Co. Ltd

Intervention(s):

  • Drug: Nivolumab
  • Drug: Cetuximab
  • Drug: Methotrexate
  • Drug: Docetaxel

Phase:

Phase 3

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting