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

Running, not enrolling · Phase 2

Conditions studied: Ovarian Cancer, Clear Cell Carcinoma, Endometrial Cancer, Cervical Carcinoma, Metastatic Castration-Resistant Prostate Cancer (mCRPC)

In brief

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.

Key facts

Study ID

NCT05032040

Run by

Xencor, Inc.

People needed

170

Starts

2022-07-21

Expected to finish

2025-12-30

Last updated by the study team

2025-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

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
• 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

Where it is running

• Arizona Oncology Associates, PC - NAHOA — Prescott, Arizona, United States
• UCSD Moores Cancer Center — La Jolla, California, United States
• Valkyrie Clinical Trials — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Kaiser Permanente Medical Group — Riverside, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States
• Medical Oncology Hematology Consultants, PA — Newark, Delaware, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Comprehensive Cancer Centers of Nevada-Southern Hills — Las Vegas, Nevada, United States
• NYU Langone Health — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• Texas Oncology - Central South — Austin, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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