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NCT03551782

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

Completed Phase 1 Last updated 25 February 2022
What this trial tests

Phase 1 trial testing Cetrelimab 480 mg in Castration-Resistant Prostatic Neoplasms in 33 participants. Completed in 11 November 2021.

Timeline
28 June 2018
Primary endpoint
11 November 2021
11 November 2021

Quick facts

Lead sponsorJanssen Research & Development, LLC
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment33
Start date28 June 2018
Primary completion11 November 2021
Estimated completion11 November 2021
Sites34 locations across Italy, Netherlands, Russia, Belgium, Canada, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

18 and older, male only, with Castration-Resistant Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Neuroendocrine and Aggressive-Variant Prostate Cancer.
    Spetsieris N, Boukovala M, Patsakis G, Alafis I, et al · · 2020 · cited 62× · PMID 33339136 · DOI 10.3390/cancers12123792
  2. Advances in landscape and related therapeutic targets of the prostate tumor microenvironment.
    Li D, Xu W, Chang Y, Xiao Y, et al · · 2023 · cited 21× · PMID 37294106 · DOI 10.3724/abbs.2023092
  3. Immunotherapy in Advanced Prostate Cancer-Light at the End of the Tunnel?
    von Amsberg G, Alsdorf W, Karagiannis P, Coym A, et al · · 2022 · cited 15× · PMID 35269712 · DOI 10.3390/ijms23052569
  4. A Complete Response to Combined Immunotherapy in a Patient with an ATM plus SF3B1 Mutation and a Moderate Tumor Mutational Burden with a High-Grade Treatment-Emergent Neuroendocrine Prostate Cancer: Case Report and Review of the Literature.
    Ferreira Bruzzi Porto H, C K Lopes G, B V Bekierman H, Altino De Almeida S, et al · · 2024 · PMID 39474562 · DOI 10.1159/000540573

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