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NCT03551782 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Castration-Resistant Prostatic Neoplasms, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 20
- Study locations
NCT03551782: Completed Phase 1 study of Castration-Resistant Prostatic Neoplasms, sponsored by Janssen Research & Development.
NCT03551782 is a Phase 1 study of Castration-Resistant Prostatic Neoplasms that has completed, run by Janssen Research & Development. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03551782, a Phase 1 study of Castration-Resistant Prostatic Neoplasms, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Conditions Studied
Interventions
- DRUG Cetrelimab 480 mg
- DRUG Apalutamide 240 mg
Study Locations (20)
Other
- Grand Hôpital de Charleroi, site Notre Dame - Charleroi
- AZ Maria Middelares - Ghent
- Istituto Europeo di Oncologia Servizio Radioterapia - Milan
- NKI-AVL, Amsterdam - Amsterdam
- UMC Radboud - Nijmegen
- Sint Franciscus Gasthuis - Rotterdam
New York
- New York University Langone Medical Center - New York
- Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg - New York
Pennsylvania
- Centers for Advanced Urology, LLC; d/b/a MidLantic Urology - Bala-Cynwyd
- Thomas Jefferson University - Philadelphia
California
- University of California San Francisco (UCSF) - Prostate Cancer Center - San Francisco
Louisiana
- Regional Urology LLC - Shreveport
Michigan
- University of Michigan Health System - Ann Arbor
Mississippi
- Washington University - Bay Saint Louis
North Carolina
- Levine Cancer Institute, Carolinas HealthCare System - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2018-06-28 |
| Est. Completion | 2021-11-11 |
| Phase | Phase 1 |
What the finished NCT03551782 record still lists
NCT03551782 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Castration-Resistant Prostatic Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Cetrelimab 480 mg is the first listed.
NCT03551782 names 20 study sites across 13 states, led by Other, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03551782 about?
NCT03551782 is a clinical study titled "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". 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.
What is the current status of trial NCT03551782?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2018-06-28. Estimated completion is 2021-11-11.
What conditions does trial NCT03551782 study?
This clinical trial studies the following conditions: Castration-Resistant Prostatic Neoplasms.
What interventions are being tested in trial NCT03551782?
The interventions under investigation include: Cetrelimab 480 mg (DRUG), Apalutamide 240 mg (DRUG).
Who is sponsoring clinical trial NCT03551782?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03551782 being conducted?
This trial has 20 study locations across California, Louisiana, Michigan, Mississippi, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03551782's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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