Study Stopped
To review the safety data.
Vudalimab (XmAb20717) in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer
Multiple-Arm Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of XmAb20717 in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer
4 other identifiers
interventional
4
1 country
2
Brief Summary
This phase I trial tests the safety and effectiveness of vudalimab (XmAb20717) in combination with standard of care treatment abiraterone, enzalutamide, or abiraterone plus docetaxel in treating patients with castration sensitive prostate cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as vudalimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding vudalimab to standard of care treatments may be effective in treating metastatic castration sensitive prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2023
CompletedFirst Posted
Study publicly available on registry
February 17, 2023
CompletedStudy Start
First participant enrolled
August 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2025
CompletedSeptember 15, 2025
September 1, 2025
1.9 years
February 8, 2023
September 8, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of Adverse Events
Will be assessed using the National Cancer Institute, Common Terminology Criteria for Adverse Events, Version 5.0 where, Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Descriptive statistics will be used to summarize the toxicity profile of the intervention. Toxicities will be tabulated by grade, association, and cycle number.
Up to 70 days post treatment
Radiographic Progression-Free Survival
Will be assessed per Prostate Cancer Working Group modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as outlined in Prostate Cancer Working Group 31 (soft tissue to be assessed by RECIST 1.1, and bone disease to be assessed by Prostate Cancer Working Group 3) by radiologic evaluation. PSA response rate: PSA decline greater than or equal to 50% from baseline up to 24 weeks from treatment initiation.
Up to 3 years
Secondary Outcomes (4)
Objective Response Rate
Up to 3 years
PSA Response Rate
Baseline up to 24 weeks from treatment initiation
PSA undetectable rate
Baseline up to 24 weeks from treatment initiation
Duration of response
Up to 3 years
Study Arms (3)
Cohort A (Vudalimab, Abiraterone)
EXPERIMENTALPatients receive vudalimab IV on days 1 and 15 plus abiraterone PO QD of 4-week cycles on study. Patients also undergo PSMA PET and FDG PET scans during screening. Patients also undergo CT and/or MRI scans, bone scans, and blood sample collection throughout the study.
Cohort B (Vudalimab, Enzalutamide)
EXPERIMENTALPatients receive vudalimab IV on days 1 and 15 plus enzalutamide PO QD of 4-week cycles on study. Patients also undergo PSMA PET and FDG PET scans during screening. Patients also undergo CT and/or MRI scans, bone scans, and blood sample collection throughout the study.
Cohort C (Vudalimab, Docetaxel, Abiraterone)
EXPERIMENTALPatients receive vudalimab IV on days 1 and 15, docetaxel IV on days 1 and 22 plus abiraterone PO QD of 6-week cycles on study. Patients also undergo PSMA PET and FDG PET scans during screening. Patients also undergo CT and/or MRI scans, bone scans, and blood sample collection throughout the study.
Interventions
Given PO
Undergo blood and stool sample collection
Undergo bone scan
Undergo CT
Given IV
Undergo FDG PET
Undergo MRI
Undergo PSMA PET
Given IV
Eligibility Criteria
You may qualify if:
- Age \>= 18 years
- Histologically confirmed adenocarcinoma of the prostate with metastatic disease
- Castration-sensitive status: either not have been treated with androgen deprivation therapy (ADT) (hormone therapy) or not on ADT at the time of progression
- Participants can have received up to 3 months of ADT with luteinizing hormone-releasing hormone (LHRH) agonists or antagonists or orchiectomy with or without concurrent first-generation antiandrogens prior to enrollment, with no radiographic evidence of disease progression or rising prostate-specific antigen (PSA) prior to enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Life expectancy \> 12 weeks as determined by the investigator
- Hemoglobin \>= 9.0 g/dl (within 28 days of cycle 1 day 1) (no transfusions allowed within 7 days of Cycle 1 Day 1 to meet entry criteria)
- White blood cell (WBC) \>= 2000/uL (within 28 days of cycle 1 day 1) (after at least 7 days without growth factor support or transfusion)
- Absolute neutrophil count (ANC) \>= 1,500/mcL (within 28 days of cycle 1 day 1) (after at least 7 days without growth factor support or transfusion)
- Platelets \>= 100,000/mcL (within 28 days of cycle 1 day 1) (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria)
- Prothrombin time (PT)/ partial thromboplastin time (PTT) =\< 1.5 x upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
- Total bilirubin =\< 1.5 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =\< 3 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
- Serum creatinine =\< 2 mg/dL (or glomerular filtration rate \>= 40 mL/min) (within 28 days of cycle 1 day 1)
- Willingness to provide pre- and post-treatment fresh tumor biopsies, if safe and medically feasible
- +4 more criteria
You may not qualify if:
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (i.e., have residual toxicities \> grade 1)
- Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs
- Prior treatment with any CTLA4, PD1, or PDL1, or directed immunotherapy
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to (investigational new drug \[IND\] agent\[s\]) or other agents used in study
- Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, ie, are without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), are clinically stable, and are without requirement of steroid treatment for at least 14 days prior to first dose of study treatment
- 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; 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 study drug (except that inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response are permitted.)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Receipt of an organ allograft
- Known history of left ventricular ejection fraction =\< 40%
- Receipt of a live-virus vaccine within 30 days prior to first dose of study drug (seasonal flu vaccines that do not contain live virus are permitted. COVID-19 vaccines are permitted)
- Known human immunodeficiency virus (HIV) positive subject with CD4+ T-cell (CD4+) counts \< 350 cells/uL, or an HIV viral load greater than 400 copies/mL, or a history of an AIDS (acquired immunodeficiency syndrome)-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 study drug dosing. (Effective ART is defined as a drug, dosage, and schedule associated with reduction and control of the viral load.)
- Known positive test for hepatitis C ribonucleic acid (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).
- Known 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 \[HBV\] deoxyribonucleic acid (DNA) test is negative, and the subject is retested for HBsAg and HBV DNA every 2 months)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- National Cancer Institute (NCI)collaborator
- Xencor, Inc.collaborator
Study Sites (2)
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bassel Nazha, MD, MPH
Emory University Hospital/Winship Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 8, 2023
First Posted
February 17, 2023
Study Start
August 3, 2023
Primary Completion
June 12, 2025
Study Completion
June 12, 2025
Last Updated
September 15, 2025
Record last verified: 2025-09