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Safety Evaluations of Nivolumab (Anti-PD-1) Added To Chemotherapy (CRT) Platforms In Patients With Intermediate And High-Risk Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma
Primary Objectives for Lead In Component
To evaluate the safety of the addition of nivolumab (anti PD-1 immunotherapy) to chemoradiotherapy with weekly cisplatin (40 mg/m2/week x 7) for patients with intermediate or high-risk head and neck squamous cell carcinoma (HNSCC) (Arm 1);
To evaluate the safety of the addition of nivolumab (anti PD-1 immunotherapy) to chemoradiotherapy with high-dose cisplatin (100 mg/m2 q 21 days x 3) for patients with intermediate or high-risk head and neck squamous cell carcinoma (HNSCC) (Arm 2);
To evaluate the safety of the addition of nivolumab (anti PD-1 immunotherapy) to chemoradiotherapy with weekly cetuximab (400 mg/m2 load, 250 mg/m2/week x 7) for patients with intermediate- or high-riskhead and neck squamous cell carcinoma (HNSCC) (Arm 3);
To evaluate the safety of the addition of nivolumab (anti PD-1 immunotherapy) to radiotherapy for patients with intermediate or high-risk head and neck squamous cell carcinoma (HNSCC) with age greater than 70 years; Zubrod Performance Status 2; baseline grade greater than or equal to 3 neuropathy; grade greater than or equal to 2 hearing loss; or CrCl less than 50 ml/min (Arm 4).
Secondary Objective for Lead In Component
To evaluate the safety, feasibility and patient compliance with adjuvant administration of single agent nivolumab to a maximum of 1 year of therapy (nivolumab, 480 mgs q 28 days x 7)
Primary Objective for Phase III Trial
To compare overall survival (OS) for patients with newly diagnosed, intermediate or high-risk local-regionally advanced HNSCC treated with cisplatin-based CRT with or without nivolumab.
Secondary Objectives for Phase III Trial
To compare progression-free survival (PFS) for patients with newly diagnosed intermediate or high-risk local-regionally advanced HNSCC treated with cisplatin-based CRT with or without nivolumab;
To compare acute and chronic toxicities in patients treated with or without nivolumab;
To compare quality of life in patients treated with or without nivolumab;
To evaluate associations between tumor PD-L1 expression and PFS and OS in patients treated with and without nivolumab;
To evaluate associations between HPV E6/E7 seroreactivity and PFS in p16-positive patients treated with and without nivolumab;
To evaluate the frequency and functional phenotype of circulating activated T cells and intra-tumoral PD-1+ T cells in patients treated with and without nivolumab.
Primary Objectives for Lead In Component
To evaluate the safety of the addition of nivolumab (anti PD-1 immunotherapy) to chemoradiotherapy with weekly cisplatin (40 mg/m2/week x 7) for patients with intermediate or high-risk head and neck squamous cell carcinoma (HNSCC) (Arm 1);
To evaluate the safety of the addition of nivolumab (anti PD-1 immunotherapy) to chemoradiotherapy with high-dose cisplatin (100 mg/m2 q 21 days x 3) for patients with intermediate or high-risk head and neck squamous cell carcinoma (HNSCC) (Arm 2);
To evaluate the safety of the addition of nivolumab (anti PD-1 immunotherapy) to chemoradiotherapy with weekly cetuximab (400 mg/m2 load, 250 mg/m2/week x 7) for patients with intermediate- or high-riskhead and neck squamous cell carcinoma (HNSCC) (Arm 3);
To evaluate the safety of the addition of nivolumab (anti PD-1 immunotherapy) to radiotherapy for patients with intermediate or high-risk head and neck squamous cell carcinoma (HNSCC) with age greater than 70 years; Zubrod Performance Status 2; baseline grade greater than or equal to 3 neuropathy; grade greater than or equal to 2 hearing loss; or CrCl less than 50 ml/min (Arm 4).
Secondary Objective for Lead In Component
To evaluate the safety, feasibility and patient compliance with adjuvant administration of single agent nivolumab to a maximum of 1 year of therapy (nivolumab, 480 mgs q 28 days x 7)
Primary Objective for Phase III Trial
To compare overall survival (OS) for patients with newly diagnosed, intermediate or high-risk local-regionally advanced HNSCC treated with cisplatin-based CRT with or without nivolumab.
Secondary Objectives for Phase III Trial
To compare progression-free survival (PFS) for patients with newly diagnosed intermediate or high-risk local-regionally advanced HNSCC treated with cisplatin-based CRT with or without nivolumab;
To compare acute and chronic toxicities in patients treated with or without nivolumab;
To compare quality of life in patients treated with or without nivolumab;
To evaluate associations between tumor PD-L1 expression and PFS and OS in patients treated with and without nivolumab;
To evaluate associations between HPV E6/E7 seroreactivity and PFS in p16-positive patients treated with and without nivolumab;
To evaluate the frequency and functional phenotype of circulating activated T cells and intra-tumoral PD-1+ T cells in patients treated with and without nivolumab.
Recruitment Status
Past Studies