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Monoclonal Antibodies

Vudalimab + Standard Care for Prostate Cancer

Phase 1

Waitlist Available

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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events

Radiographic Progression-Free Survival

Secondary study objectives

Duration of response

Objective Response Rate

PSA Response Rate

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~4480

Biospecimen Collection

2004

Completed Phase 3

~2030