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A Phase 2 Multicohort Study of Nivolumab in Combination with Docetaxel and Androgen Deprivation Therapy in Metastatic Hormone Sensitive Prostate Cancer Patients with DNA Damage Repair Defects or Inflamed Tumors
The goal of this study is to examine the activity and safety of hormonal therapy combined with docetaxel chemotherapy and nivolumab immunotherapy for hormone sensitive prostate cancer. The study is designed to enrich for patients whose tumors may be more most responsive to this treatment strategy. All patients will receive the same treatment of ADT combined with docetaxel chemotherapy and nivolumab immunotherapy.
Primary Objective: To determine the proportion of subjects with PSA less than or equal to 0.2 ng/mL at 12 months from start of treatment in each cohort Secondary Objective: To determine the proportion of subjects with PSA less than or equal to 0.2 ng/mL at 7 months To estimate overall survival (OS) To estimate time to castration resistance To estimate time to clinical progression To estimate time to prostate specific antigen (PSA) or serologic progression To determine the objective response rate in subjects with measurable disease To assess safety and tolerability to chemohormonal-immunotherapy in the upfront management of mHSPC
ADT (); BMS-936558 (Nivolumab); Firmagon (); Lupron (leuprolide acetate); Nivolumab (Opdivo); Taxotere (docetaxel); Zoladex (); docetaxel (); goserelin acetate (Zoladex)