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

Titre officiel

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

Sommaire:

L’objectif de cette étude est d’évaluer l’innocuité de l’association de l’anticorps JNJ-63723283 à l’apalutamide et de définir une population de participants atteints d’un cancer de la prostate métastatique résistant à la castration (CPRCm) répondant au traitement d’association (JNJ-63723283 + apalutamide).

Description de l'essai

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 originally diagnosed with adenocarcinoma of the prostate who have now developed mCRPC and who have progressed on therapy with abiraterone acetate plus prednisone/prednisolone (AA-P), apalutamide, or enzalutamide. Participants with treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) assessed by the screening biopsy may be considered for this study. 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 cetrelimab 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 cetrelimab in combination with apalutamide will be evaluated.

Voir cet essai sur ClinicalTrials.gov

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