A Study of XmAb20717 (Vudalimab)in Patients With Selected Advanced Gynecologic and Genitourinary Malignancies
A Phase 2 Study of XmAb20717 in Patients With Selected Gynecological Malignancies and Metastatic Castration-Resistant Prostate Cancer
1 other identifier
interventional
170
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Jul 2022
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2021
CompletedFirst Posted
Study publicly available on registry
September 2, 2021
CompletedStudy Start
First participant enrolled
July 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedFebruary 7, 2025
February 1, 2025
3.2 years
August 31, 2021
February 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 weeks
Study Arms (1)
vudalimab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
- +6 more criteria
You may not qualify if:
- Subjects currently receiving other anticancer therapies, except that subjects with mCRPC may continue to receive luteinizing hormone-releasing hormone (LHRH) analogue therapy
- More than 2 prior chemotherapy regimens for subjects in the cervical cancer, CCC, HGSOC, or mCRPC cohorts
- Progression on more than 2 prior lines of androgen receptor signal inhibitor therapy (mCRPC cohort)
- Prior treatment with a CTLA4-targeted agent
- Prior treatment with nivolumab, pembrolizumab, or any other PD1-, PDL1- or programmed cell death ligand 2- (PDL2)-directed therapy, except that:
- 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
- Treatment with any other anticancer therapy within 2 weeks of the start of study drug (ie, other immunotherapy, chemotherapy, radiation therapy, etc.)
- A life-threatening (Grade 4) immune-mediated adverse event (AE) associated with prior administration of an immunotherapy agent
- Failure to recover from any immunotherapy-related toxicity from prior cancer therapy to ≤ Grade 1, except that subjects are eligible if a previous immunotherapy-related endocrinopathy is medically managed with hormone replacement therapy only
- Failure to recover from any other cancer therapy-related toxicity (other than immune-related toxicity) related to previous anticancer treatment to ≤ Grade 2
- Have known active central nervous system metastases and/or carcinomatous meningitis
- Platelet count \< 100 × 109/L
- Hemoglobin level ≤ 9.0 g/dL
- Absolute neutrophil count \< 1.5 × 109/L
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xencor, Inc.lead
- ICON plccollaborator
Study Sites (17)
Arizona Oncology Associates, PC - NAHOA
Prescott, Arizona, 86301, United States
UCSD Moores Cancer Center
La Jolla, California, 92037, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
UCLA Medical Center
Los Angeles, California, 92004, United States
Kaiser Permanente Medical Group
Riverside, California, 92505, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, 19713, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Comprehensive Cancer Centers of Nevada-Southern Hills
Las Vegas, Nevada, 89148, United States
NYU Langone Health
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Texas Oncology - Central South
Austin, Texas, 78745, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jolene Shorr
Xencor, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2021
First Posted
September 2, 2021
Study Start
July 21, 2022
Primary Completion
October 15, 2025
Study Completion
December 30, 2025
Last Updated
February 7, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share