A Study of XmAb20717 (Vudalimab)in Patients With Selected Advanced Gynecologic and Genitourinary Malignancies
18 Years and older, Male and Female
XmAb20717-05 (primary)
NCI-2022-03108
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.
Objectives
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
- 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 duration of response [DOR].
In Stage 2, up to 20 additional subjects with mCRPC with or without measurable disease
will be enrolled; the primary endpoint is PSA50.
Eligibility
- Able to provide written informed consent
- Adult (age = 18 years)
- Cancer must have progressed after treatment with standard of care therapy approved for the treatment of that indication
- Histologically confirmed diagnosis of one of the following tumor types, along with clinical/pathologic confirmation of the additional requirements for each indication, as appropriate:
- 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:
- PSA progression, defined as at least 2 rises in PSA with a minimum of a 1-week interval
- Soft-tissue progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Progression of bone disease (evaluable disease) or 2 or more new bone lesions by bone scan
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in Stage 1
- Patients with mCRPC without measurable disease are eligible in for Stage 2
- Adequate available archival formalin-fixed paraffin-embedded block(s)/slides containing tumor and/or adequate predose fresh tumor biopsy tissue
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Female subjects of childbearing potential must agree to use a highly effective method of birth control during and for 4 weeks after the last dose of XmAb20717. Women are considered to be of childbearing potential unless it is documented that they are over the age of 60 OR postmenopausal by history with no menses for 1 year and confirmed by follicle-stimulating hormone (using local reference ranges) OR have a history of hysterectomy and/or bilateral oophorectomy OR have a history of bilateral tubal ligation.
- Fertile male subjects must be willing to practice a highly effective method of birth control during and for 4 weeks after last dose of XmAb20717
- Male subjects must agree not to donate sperm from screening through 4 weeks after last dose of XmAb20717
- Able and willing to complete the entire study according to the study schedule
Treatment Sites in Georgia
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