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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
Phase 1 trial testing Cetrelimab 480 mg in Castration-Resistant Prostatic Neoplasms in 33 participants. Completed in 11 November 2021.
11 November 2021
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 28 June 2018 |
| Primary completion | 11 November 2021 |
| Estimated completion | 11 November 2021 |
| Sites | 34 locations across Italy, Netherlands, Russia, Belgium, Canada, United States, Spain |
Drugs / interventions tested
- Cetrelimab 480 mg — full drug profile →
- Apalutamide 240 mg — full drug profile →
Conditions studied
- Castration-Resistant Prostatic Neoplasms — all drugs for Castration-Resistant Prostatic Neoplasms →
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):
-
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT03551782
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cetrelimab 480 mg
Trials testing the same drug.
- NCT03431350 — A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer · Phase 2 · active not recruiting
Other Janssen Research & Development, LLC trials
Trials by the same sponsor.
- NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
- NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
- NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03551782 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
- Last refreshed: 25 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03551782.
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