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Monoclonal Antibodies
Vudalimab + Standard Care for Prostate Cancer
Phase 1
Recruiting
Led By Bassel Nazha, MD, MPH
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial tests if adding vudalimab to standard treatments can help fight advanced prostate cancer. Immunotherapy may help the body's immune system attack the cancer.
Who is the study for?
Men aged 18+ with metastatic castration sensitive prostate cancer can join this trial. They must have a life expectancy over 12 weeks, adequate organ function, and agree to use contraception for 120 days post-treatment. Excluded are those with severe allergies to similar drugs, recent chemo or radiotherapy, certain heart conditions, active infections or autoimmune diseases, uncontrolled illnesses that could limit compliance, or known HIV/AIDS not well-controlled by therapy.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of vudalimab (XmAb20717) combined with standard treatments like abiraterone or enzalutamide for advanced prostate cancer. Vudalimab is an immunotherapy drug designed to help the immune system fight cancer and may work better when added to existing treatments.See study design
What are the potential side effects?
Vudalimab might cause immune-related reactions since it works on the body's immune system. Standard treatments like abiraterone and enzalutamide can cause fatigue, hot flashes, joint pain and high blood pressure. The combination treatment's side effects will be monitored closely.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events
Radiographic Progression-Free Survival
Secondary outcome measures
Duration of response
Objective Response Rate
PSA Response Rate
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort C (Vudalimab, Docetaxel, Abiraterone)Experimental Treatment9 Interventions
Patients 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.
Group II: Cohort B (Vudalimab, Enzalutamide)Experimental Treatment8 Interventions
Patients 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.
Group III: Cohort A (Vudalimab, Abiraterone)Experimental Treatment8 Interventions
Patients 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone
2012
Completed Phase 4
~2830
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Docetaxel
1995
Completed Phase 4
~5620
Enzalutamide
2014
Completed Phase 4
~2760
PSMA PET Scan
2020
N/A
~10
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,502 Total Patients Enrolled
17 Trials studying Prostate Cancer
7,157 Patients Enrolled for Prostate Cancer
Xencor, Inc.Industry Sponsor
29 Previous Clinical Trials
2,723 Total Patients Enrolled
1 Trials studying Prostate Cancer
78 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,652 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I finished all my previous cancer treatments at least 2 weeks ago.My cancer is sensitive to hormone therapy, and I am not currently on hormone therapy.I am willing to have tumor biopsies before and after treatment.I am willing and able to follow the study's schedule and procedures.I have not received a live-virus vaccine in the last 30 days.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I can take care of myself but might not be able to do heavy physical work.I have previously received immunotherapy targeting CTLA4, PD1, or PDL1.I have signed a consent form understanding my cancer and the study.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.My prostate cancer has spread to other parts of my body.My kidney function is within the required range.I am a man who is either surgically sterile or willing to use contraception.I have received an organ transplant from another person.I am 18 years old or older.I haven't taken steroids or immunosuppressants in the last 14 days.I have an active autoimmune disease.My heart's pumping ability is below 40%.I have cancer that has spread to my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort C (Vudalimab, Docetaxel, Abiraterone)
- Group 2: Cohort B (Vudalimab, Enzalutamide)
- Group 3: Cohort A (Vudalimab, Abiraterone)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the administration sanctioned Cohort A (Vudalimab, Abiraterone) for use?
"Cohort A (Vudalimab, Abiraterone) was assigned a risk rating of 1 on our scale due to the preliminary nature of this Phase I trial and limited safety/efficacy data."
Answered by AI
Are there current vacancies within this research project for participants?
"According to the documentation on clinicaltrials.gov, this study is not welcoming new patients presently. The trial was initially advertised on March 20th of 2023 and underwent its last update February 8th of that same year. Fortunately, there are currently 1472 other trials in search of participants at any given moment."
Answered by AI
What are the primary aims of this trial?
"The primary objective of this trial, evaluated over a 70-day post-treatment period, is to assess Radiographic Progression-Free Survival. Meanwhile, secondary outcomes such as PSA Response Rate (defined as a PSA decline >= 50%), PSA Undetectable Rate (PSA < 0.2 ng/mL up to 24 weeks from treatment initiation), and Duration of Response (per PCWG-modified RECIST 1.1) will be estimated by summary statistics like mean/median & quartiles with 95% exact confidence intervals; the fold change in CD8 T cell or other tumor specific cells before and"
Answered by AI
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