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A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients with Early-Stage, P16 Positive, Non-Smoking Associated Oropharyngeal Cancer
This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.
Primary Objective Phase II To demonstrate non-inferiority in terms of progression-free survival (PFS) of concurrent reduced-dose radiation therapy (RT) with cisplatin or concurrent reduced-dose radiation therapy with nivolumab to the current standard of care (standard-dose RT with cisplatin). Phase III To demonstrate co-primary endpoints of non-inferiority of PFS and superiority of quality of life (QOL) as measured by the MDADI of concurrent reduced-dose radiation with cisplatin or concurrent reduced-dose radiation with nivolumab to the current standard of care (standard-dose RT with cisplatin). Secondary Objectives -To compare patterns of failure (local and regional relapse versus distant) and overall survival between each experimental arm and the control arm; -To assess long term PFS, overall survival, and toxicity between each experimental arm and the control arm; -To determine acute and late toxicity profiles as measured by the CTCAE; -To explore the symptomatic adverse events (AEs) for tolerability of each treatment arm as measured by the PRO-CTCAE; -To compare changes in patient-reported outcomes (HHIA-S, EORTC-QLQ30) between each experimental arm and the control arm; -To assess the association of FDG-PET/CT at baseline with locoregional control and PFS; -To estimate the negative predictive value of the 12-14 weeks post-RT FDG-PET/CT in terms of locoregional control rates and PFS rates at 1 and 2 years.
BMS-936558 (Nivolumab); Nivolumab (); cisplatin ()