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A Phase II, Open-Label, Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination with Durvalumab and in Combination with Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC)
This is an open-label Phase II modular study in patients with prostate cancer which will assess safety, efficacy, and tolerability of AZD4635 in combination with other therapeutic agents in different treatment arms (referred to as modules). Combinations to be studied include: 1) Module 1: AZD4635 plus durvalumab; 2) Module 2: AZD4635 plus oleclumab; 3) Module 3: AZD4635 plus durvalumab plus oleclumab. The protocol may be amended to include other combinations.
- To determine the efficacy (as assessed by radiographic progression free survival [rPFS]) of AZD4635 plus durvalumab and separately of AZD4635 plus durvalumab plus cabazitaxel in participants with mCRPC.
AMP-514 (Durvalumab); AZD4635 (); Cabazitaxel (); Durvalumab (); Jevtana (Cabazitaxel); MEDI4736 (Durvalumab)
Inclusion Criteria for all Patients in all Modules:
Exclusion Criteria for all Patients in all Modules: