This is a Phase 2, multicenter, two-stage, open-label, parallel-group study designed to evaluate the efficacy and safety of vudalimab in patients with selected advanced gynecologic and genitourinary malignancies and to identify tumor types for further evaluation.~In Stage 1, subjects will be enrolled into 1 of 5 tumor-specific, parallel cohorts (n = 10 each):~Platinum-resistant high-grade serous ovarian cancer (HGSOC)~Chemotherapy relapsed or refractory clear cell ovarian, endometrial, or peritoneal cancer~Immune-checkpoint-inhibitor-refractory microsatellite stable (MSS) endometrial cancer (EC)~Previously treated recurrent or metastatic cervical cancer~High-risk metastatic castration-resistant prostate cancer (mCRPC)~Within each tumor-specific cohort in Stage 1, a primary endpoint of ORR at 12 weeks, based on investigator review, will be used to determine cohort expansion into Stage 2. Each Stage 1 cohort that achieves an ORR of ≥ 20% (at least 2 out of 10 subjects with an objective response) will enroll up to an additional 20 subjects in Stage 2. Cohorts with an ORR of less than 20% will discontinue enrollment. However, additional factors will be considered in determining an expansion into Stage 2 (eg, enrollment rate, complete versus partial response, and DOR).
This is a Phase 2, multicenter, two-stage, open-label, parallel-group study designed to evaluate the efficacy and safety of vudalimab (XmAb20717) in patients with selected advanced gynecologic and genitourinary malignancies.