Vudalimab (XmAb20717) in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer

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.

Conditions

• Castration-Sensitive Prostate Carcinoma
• Metastatic Prostate Adenocarcinoma
• Stage IVB Prostate Cancer AJCC v8

Interventions

DRUG

Abiraterone

Given PO

PROCEDURE

Biospecimen Collection

Undergo blood and stool sample collection

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Docetaxel

Given IV

DRUG

Enzalutamide

Given PO

PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG PET

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

PSMA PET Scan

Undergo PSMA PET

DRUG

Vudalimab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Xencor, Inc.

  collaborator INDUSTRY

• Emory University

  lead OTHER

Principal Investigators

• Bassel Nazha, MD, MPH · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-03

Primary Completion

2025-06-12

Completion

2025-06-12

FDA Drug

Yes

Countries

• United States

Study Locations