At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Androgen Deprivation Therapy, Nivolumab, and 1 other intervention for Hormone Sensitive Prostate Cancer and 2 related conditions. Active but no longer recruiting, targeting 47 participants across 6 sites.
Detailed Summary
This research study is studying a combination of hormonal therapy, chemotherapy, and immunotherapy as a possible treatment for metastatic hormone-sensitive prostate cancer. The names of the study drugs involved in this study are: * Androgen deprivation therapy (ADT) with a drug of your physician's choice. This may include leuprolide (Lupron), goserelin acetate (Zoladex), or degarelix (Firmagon). * Docetaxel * Nivolumab
Study Details
Timeline
Interventions
Given per standard care for duration of study. Regimens include Leuprolide (Lupron Depot) intramuscularly every 3 months, Goserelin acetate (Zoladex) subcutaneously every 4 weeks, or degarelix (Firmagon) subcutaneously every month per standard of care.
Given once per every 3 weeks for cycle 1-6 intravenously and then every 4 weeks during subsequent cycles, at predetermined dosage; up to 28 cycles total.
Given once every 3 weeks intravenously at pre determined dosage for cycle 1-6.