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Clinical Trial VICCHN1433

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)

Principal Investigator(s)

Jill Gilbert

Details

  • Protocol No. VICCHN1433
  • Open Date: 07/16/2014
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: To compare PFS and OS of Nivolumab to Investigator's Choice in subjects who have tumor progression within 6 months of last dose of platinum therapy in the primary, recurrent, or metastatic setting.
  • Disease Sites: Head/Neck
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Cetuximab; Cetuximab (Erbitux); Docetaxel; Docetaxel (Taxotere); Methotrexate; Nivolumab (BMS-936558)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02105636
  • Secondary Protocol No: CA209141

Description

Participants are being asked to take part in this research study because they have recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck. The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

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