Active — Not RecruitingPhase 2

A Study of XmAb20717 (Vudalimab)in Patients With Selected Advanced Gynecologic and Genitourinary Malignancies

United States170 participantsStarted 2022-07-21

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Persistent or recurrent clear cell carcinoma of the ovary, peritoneum, or endometrium after treatment with platinum-based systemic chemotherapy
✓. Persistent or recurrent high-grade serous carcinoma of the ovary, fallopian tube, or peritoneum after treatment with platinum-based systemic chemotherapy (except subjects with a diagnosis of carcinosarcoma)
✓. Recurrent or metastatic cervical carcinoma previously treated with standard-of-care systemic chemotherapy and FDA-approved immunotherapy, if eligible
✓. Advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) in patients who are not candidates for curative surgery or radiation, and that has progressed following treatment with no more than one prior line of systemic therapy and prior treatment with FDA-approved combination therapy consisting of a checkpoint inhibitor and a targeted agent
✓. For patients with mCRPC castration-resistant prostate cancer defined as progressive disease (PD) after surgical castration, or progression in the setting of medical androgen ablation with a castrate level of testosterone (\< 50 ng/dL)
✓. Documented progressive mCRPC based on at least 1 of the following:

Exclusion criteria

✕. Subjects with MSS EC may have received anti-PD1 therapy as part of an FDA-approved regimen in the approved disease setting
✕. Subjects with cervical cancer may have received anti-PD1 therapy as an FDA-approved agent in an approved disease setting

What they're measuring

PSA50 is the primary endpoint for the mCRPC cohort. Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumours (RECIST) version 1 criteria is the primary endpoint for gynecological malignancy cohorts

Timeframe: 12 weeks

Trial details

NCT IDNCT05032040

SponsorXencor, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-15

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