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Protocol No. RTOG3504

Principal Investigator Kimple, Randall

Phase I

Age Group Adult

Scope National

Sponsor Type Industry

Title Safety Evaluations of Nivolumab (Anti-PD-1) added to Chemoradiotherapy (CRT) Platforms in Patients with Intermediate and High-Risk Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma

Objective The researchers will test the safety of adding nivolumab to radiation therapy and to the most common combinations of radiation therapy and chemotherapy.

Treatment Nivolumab can help the immune system recognize cancer cells. Nivolumab is already FDA-approved for treating patients with lung cancer and melanoma (a type of skin cancer). However, nivolumab is not part of the usual treatment of advanced head and neck cancer and is investigational in this study. The addition of nivolumab to radiation or to radiation given with chemotherapy may or may not help shrink your cancer or prevent it from coming back.

Description There are four study groups. All patients will receive nivolumab plus one of three usual treatments. The usual treatments include radiation with cisplatin (Groups 1 and 2), radiation with cetuximab (Group 3), or radiation alone (Group 4) for patients who cannot tolerate chemotherapy. Nivolumab will be given to the first 40 patients at a dose that is recommended when giving nivolumab treatment alone or in combination with chemotherapy. Nivolumab, cisplatin, and cetuximab are intravenous ("IV") medications. This means they are given as an infusion into a vein through an "IV." Patients in all groups will receive radiation therapy and nivolumab with or without chemotherapy for approximately 16 weeks. All patients will then be eligible to receive additional nivolumab therapy for a total of one year.

Key Eligibility
  • Histologically or cytologically-confirmed diagnosis of HNSCC(Head and Neck Squamous Cell Carcinoma) of the oral cavity, oropharynx, larynx, or hypopharynx
  • Intermediate-risk or High-risk Group based on diagnostic workup
  • All patients must provide their personal smoking history prior to registration
  • The patient has measurable disease
  • Patients with definitive clinical or radiologic evidence of distant (beyond cervical lymph node and neck tissue) metastatic disease are ineligible
  • Patients with oral cavity cancer are excluded from participation if resection of the primary tumor is considered technically feasible by an oral or head and neck cancers surgical subspecialist
  • Patients with carcinoma of the neck of unknown primary site origin are ineligible
  • Patients with gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease are ineligible
  • Patients with prior systemic chemotherapy for the study cancer are ineligible
  • Patients with active autoimmune disease are ineligible
  • Patients with known immunosuppressive disease, for example HIV infection or history of bone marrow transplant or CLL are ineligible
  • Patients with a positive test for hepatitis B virus surface antigen or hepatitis C virus indicating acute or chronic infection are ineligible

Applicable Disease Sites Head and Neck

Therapies Involved Cytotoxic Chemotherapy; Other; Radiotherapy

Drugs Involved BMS-936558 (Nivolumab); Cetuximab; Nivolumab; Opdivo (Nivolumab); anti-EG Fr antibody c225 (Cetuximab); anti-epidermal growth factor receptor antibody c225 (Cetuximab); c225 (Cetuximab); cis-diamminedichloroplatinum (cisplatin); cisplatin; placebo; platinol (cisplatin); platinum (cisplatin)

Status Open

Participating Institutions UW Hospital and Clinics