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).
Source: View full study details on ClinicalTrials.gov
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