Spots Global Cancer Trial Database for Nivolumab, Ipilimumab, and Radiation Therapy in Treating Patients With Stage III-IVB Head and Neck Cancer

Study Description

Brief Summary: This pilot clinical trial studies the side effects of nivolumab, ipilimumab and radiation therapy in treating patients with stage IVA-B head and neck cancer. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may work better in treating patients with stage IVA-B head and neck cancer.

Detailed Description: PRIMARY OBJECTIVES: I. To investigate the safety of the combination of nivolumab and ipilimumab with radiation treatment for definitive management of patients with locally advanced squamous cell carcinoma of the head and neck. SECONDARY OBJECTIVES: I. To estimate the 1 year progression-free survival (PFS) in all patients treated. II. To assess the overall response rate and overall survival of patients at one year TERTIARY OBJECTIVES: I. To explore whether PDL1 expression is associated with treatment response. II. To explore whether there is a net change in the Th1/Th2 ratio (IFN-gamma, IL-4, IL10, etc) or cell subset frequencies (M2 monocytes, myeloid-derived suppressor cells, etc) within a patient's peripheral blood either at baseline or in response to treatment is associated with treatment response. III. To explore whether exosomes or other immune related serum biomarkers change after combination therapy.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial