A Study of JNJ-63723283, a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, Administered in Combination With Apalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer

Official Title

An Open-label, Multicentre, Phase 1b Study of JNJ-63723283, a PD-1 Inhibitor, Administered in Combination With Apalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer

Summary:

The purpose of this study is to evaluate the safety of the combination of JNJ-63723283 with apalutamide and to define a population of participants with metastatic castration-resistant prostate cancer (mCRPC) who respond to treatment with the combination of JNJ-63723283 and apalutamide.

Trial Description

Primary Outcome:

  • Number of Participants With Adverse Events (AEs)
  • Number of Participants with AEs by Severity
  • Percentage of Participants with Prostate-Specific Antigen (PSA) Response at Week 12
Secondary Outcome:
  • Maximal PSA Decline
  • Percentage of Participants with Circulating Tumour Cell (CTC) Response
This study is of participants with mCRPC who have progressed after therapy with an androgen receptor (AR)-targeted agent and have not received chemotherapy. Participants must have confirmed prostate-specific antigen (PSA) progression per Prostate Cancer Clinical Trials Working Group (PCWG3) criteria. The primary hypothesis is that treatment with JNJ-63723283 and apalutamide is safe and leads to improvement in the 12-week PSA response rate. The study consists of Screening period (28 days prior to Cycle 1 Day 1), Treatment Period, End-of-Treatment Visit (performed after the last dose of study drug is administered), and Follow-up Period (participants will have Follow-up assessment every 12 weeks after the End-of-Treatment Visit). The efficacy, safety, and pharmacokinetics of JNJ-63723283 in combination with apalutamide will be evaluated.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society