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Ovarian CancerPhase 2NCT05032040

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

A Phase 2 study testing vudalimab in people with Ovarian Cancer and Clear Cell Carcinoma, run by Xencor, Inc. at 17 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
vudalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
17 sitesUnited States
Study dates
21 Jul 2022to 30 Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 21Show fewer
  • 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

Who cannot join

  • 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
Show all 35Show fewer
  • 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
  • Aspartate aminotransferase (AST) at screening > 3 × upper limit of normal (ULN) for subjects without known liver involvement by tumor; or > 5 × ULN for subjects with known liver involvement by tumor
  • Alanine aminotransferase (ALT) at screening > 3 × ULN for subjects without known liver involvement by tumor; or > 5 × ULN for subjects with known liver involvement by tumor
  • Bilirubin ≥ 1.5 × ULN (unless prior diagnosis and documentation of ongoing hemolysis or Gilbert's syndrome has been made)
  • Estimated creatinine clearance < 50 mL/minute calculated by the Cockcroft Gault or Modification of Diet in Renal Disease formulas
  • Active known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus or residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; autoimmune adrenal insufficiency that is managed with low-dose corticosteroids; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs)
  • • Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of XmAb20717 (except that inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response are permitted)
  • Receipt of an organ allograft
  • History of small or large bowel obstruction within 3 months of enrollment, including subjects with palliative gastric drainage catheters. Subjects with palliative diverting ileostomy or colostomy are allowed if they have been symptom-free for more than 3 months.
  • Ongoing bowel perforation or presence of bowel fistula or intra-abdominal abscess
  • Subjects with refractory ascites, for example, ascites needing drainage catheter or therapeutic paracentesis more often than every 4 weeks
  • Histologic diagnosis of carcinosarcoma of the ovary
  • Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
  • History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic, or psychiatric) other than their primary malignancy, that, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study evaluations, procedures, or completion
  • Evidence of any serious bacterial, viral, parasitic, or systemic fungal infections within the 30 days prior to the first dose of study drug
  • Receipt of a live-virus vaccine within 30 days prior to first dose of study drug (Seasonal flu and COVID-19 vaccines are permitted, as long as they do not contain live virus. Seasonal flu vaccines should no be administered within 24 hours of planned administration of XmAb20717. COVID-19 vaccines should be administered 48 to 72 hours before or after XmAb20717 dosing
  • Known HIV-positive subject with CD4+ T-cell (CD4+) counts < 350 cells/μL, or an HIV viral load greater than 400 copies/mL, or a history of an AIDS-defining opportunistic infection within the past 12 months, or who has not been on established antiretroviral therapy (ART) for at least 4 weeks prior to initiation of XmAb20717 dosing. (Effective ART is defined as a drug, dosage, and schedule associated with reduction and control of the viral load. HIV positive subjects who do not meet any of these exclusion criteria are eligible.)
  • Positive test for hepatitis C RNA (a subject who is hepatitis C virus [HCV] antibody positive but HCV RNA negative due to documented, curative prior antiviral treatment or natural resolution is eligible)
  • Positive test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb); a subject whose HBsAg is negative and HBcAb is positive may be enrolled if a hepatitis B virus (HBV) DNA test is negative and the subject is retested for HBsAg and HBV DNA every 2 months.
  • Subject is pregnant or breastfeeding or planning to become pregnant while enrolled in the study, up to the final end-of-treatment visit
  • Positive urine pregnancy test (ie, urine human chorionic gonadotropin)

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • Texas Oncology - Central South

    Austin, Texas, 78745

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • UCSD Moores Cancer Center

    La Jolla, California, 92037

  • Comprehensive Cancer Centers of Nevada-Southern Hills

    Las Vegas, Nevada, 89148

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • UCLA Medical Center

    Los Angeles, California, 92004

  • NYU Langone Health

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10032

  • Medical Oncology Hematology Consultants, PA

    Newark, Delaware, 19713

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • Arizona Oncology Associates, PC - NAHOA

    Prescott, Arizona, 86301

  • Kaiser Permanente Medical Group

    Riverside, California, 92505

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 2 Study of XmAb20717 in Patients With Selected Gynecological Malignancies and Metastatic Castration-Resistant Prostate Cancer

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.

Read the detailed description

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.

Being tested
vudalimab
Keywords
Endometrial Cancer, Ovarian Cancer, Cervical Cancer, Prostate Cancer, Gynecological Cancer,, Fallopian Tube Cancer, Peritoneal Cancer, Clear Cell Carcinoma, vudalimab, XmAb20717
Medical subject headings
Ovarian Neoplasms, Adenocarcinoma, Clear Cell, Endometrial Neoplasms, Uterine Cervical Neoplasms, Prostatic Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vudalimabBiological

    Monoclonal bispecific antibody

Study groups in NCT05032040
Study groupRoleWhat they receive
vudalimabExperimentalNot described
Receives: Biological: vudalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2021
  2. Study start21 Jul 2022
  3. Primary completion15 Oct 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05032040
Sponsor's protocol ID
XmAb20717-05
Status last verified
Feb 2025
First submitted
31 Aug 2021
Last updated
7 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hushmandi K, Einollahi B, Lee EHC, Sakaizawa R, Glaviano A, Reiter RJ, Saadat SH, Farani MR, Huh YS, Aref AR, Salimimoghadam S, Kumar AP. Bispecific antibodies as powerful immunotherapeutic agents for urological cancers: Recent innovations based on preclinical and clinical evidence. Int J Biol Sci. 2025 Jan 27;21(4):1410-1435. doi: 10.7150/ijbs.96155. eCollection 2025.

    PubMed 39990653

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing vudalimab in people with Ovarian Cancer and Clear Cell Carcinoma, run by Xencor, Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05032040, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.

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