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Combination of Nivolumab Immunotherapy with Radiation Therapy and Androgen Deprivation Therapy in the Management of Gleason Group 5 Prostate Cancer
The purpose of this study is to test the safety, tolerability, and effectiveness of the investigational drug nivolumab (Opdivo™) in combination with high dose radiation. Investigators also want to see if these study drugs help to delay the progression of prostate cancer.
Primary Objectives: Phase I safety lead in: To determine the safety and feasibility of combining nivolumab with RT and ADT in patients with Gleason Group 5 PCa. Phase II: To determine the 2-year biochemical relapse free survival rate of nivolumab combined with definitive RT in patients with Gleason Group 5 PCa. Secondary Objectives: - To observe and record anti-tumor activity as defined by "time to PSA nadir". Although the clinical benefit of nivolumab has not yet been established in PCa, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. - To assess the acute and late nonhematologic and hematologic toxicity profile - To describe patient-reported outcomes including EPIC, AUA Symptom Index, and SHIM for patients treated with nivolumab, combined with RT and ADT. Exploratory Objectives: - To understand the impact of nivolumab on the temporal expression pattern of immune ligands in prostate tissue. - To understand the immune milieu (T cell repertoire, macrophage and NK cells), T cell dynamics, and clonal shifts in the presence of nivolumab and RT. - To identify blood biomarkers that immune-mediated treatment response in PCa.
BMS-936558 (Nivolumab); Casodex (Bicalutamide); Lupron (leuprolide acetate); Nivolumab (Opdivo)