Study on ZEN-3694, Enzalutamide, and Pembrolizumab for Treating Metastatic Castration-Resistant Prostate Cancer

Sponsor: Rahul Aggarwal

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04471974

Provider View

This clinical trial is exploring a new combination of drugs—ZEN-3694, enzalutamide, and pembrolizumab—to see how well they work together in treating prostate cancer that has spread and is resistant to hormone therapy.

Patient Parameters

Program Overview

This study is testing a combination of three drugs—ZEN-3694, enzalutamide, and pembrolizumab—to see if they can help treat prostate cancer that has spread to other parts of the body and is resistant to hormone therapy. ZEN-3694 works by blocking a gene that helps cancer cells grow. Enzalutamide stops testosterone from reaching cancer cells, slowing their growth. Pembrolizumab helps the immune system attack cancer cells. The study aims to find out how effective this combination is for patients whose cancer has continued to grow despite previous treatments.

Description

In this study, patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously tried other treatments will receive a combination of ZEN-3694, enzalutamide, and pembrolizumab. The study is divided into two groups: Cohort A includes patients with a specific type of mCRPC, and Cohort B includes those without this specific type. Initially, a small group of patients will be tested to ensure the treatment is safe. If successful, more patients will be enrolled.

Patients will receive pembrolizumab through an IV on the first day of each cycle, and take ZEN-3694 and enzalutamide pills daily for 21 days. If patients were not taking enzalutamide before the study, they will start ZEN-3694 on the second cycle. The treatment cycles repeat every 21 days unless the cancer progresses or side effects become too severe.

After finishing the treatment, patients will have follow-up visits every 30 days and then every 90 days until the study ends or they are no longer able to participate.

The main goal is to see how many patients respond to the treatment. Other goals include measuring how long the response lasts, how long patients live without the cancer getting worse, and overall survival rates. The study will also look at the safety of the treatment and explore how different tumor characteristics and blood markers relate to treatment outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must have prostate cancer that has spread and is resistant to hormone therapy.
  • Cancer must be progressing, shown by rising PSA levels or scans.
  • Must have a PSA level over 2 ng/mL or measurable disease.
  • Must have tried at least one other hormone therapy drug.
  • No prior chemotherapy for this type of prostate cancer, unless it was more than 6 months ago.
  • Must be 18 years or older.
  • Must have good overall health and organ function.
  • Must agree to use effective birth control during the study and for 60 days after.
  • Must be willing to have a tumor biopsy if needed.

Exclusion Criteria

  • Cannot have participated in another study with a different investigational drug within 2 weeks.
  • Cannot have allergies to any of the study drugs.
  • Cannot have had recent radiation therapy or certain other treatments.
  • Cannot have a second active cancer needing treatment.
  • Cannot have an active autoimmune disease needing treatment in the past 2 years.
  • Cannot have received a live vaccine recently.
  • Cannot have certain heart conditions or a history of seizures.
  • Cannot have an active infection needing IV antibiotics recently.
  • Cannot have had major surgery recently.
  • Cannot have any condition that would interfere with the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.