An Open-Label, Phase 2 Study Of Nivolumab In Combination With Either Rucaparib, Docetaxel, Or Enzalutamide In Men With Castration-Resistant Metastatic Prostate Cancer (Mcrpc; Checkmate 9kd).

TPS3126Background: Although multiple new agents have been approved for mCRPC over the last decade, median survival remains unsatisfactory at ~12-35 months. Immunotherapy targeted solely at programmed death-1 (PD-1)/PD-1 ligand-1 (PD-L1) interactions has shown limited evidence of antitumor activity in patients (pts) with prostate cancer, likely due to the immunologically “cold” nature of the tumor and low PD-L1 expression on tumor cells. However, if existing prostate cancer treatments can trigger an adaptive immune response, attracting infiltrating immune cells and increasing tumor PD-L1 expression, there is a rationale for combination with anti-PD-1/PD-L1 inhibitors to improve outcomes. The current phase 2 study will evaluate combinations of the PD-1 inhibitor nivolumab with either rucaparib (PARP inhibitor), docetaxel, or enzalutamide (androgen receptor inhibitor) in men aged ≥18 years with mCRPC (NCT03338790). Methods: Key inclusion criteria: Histologic confirmation of adenocarcinoma of the prostate, ev...