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NCT04382898 · ClinicalTrials.gov registry record · Phase 1
PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)
A Phase 1 study, sponsored by BioNTech SE.
- Terminated
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT04382898: Clinical Trial Phase 1 study, sponsored by BioNTech SE.
NCT04382898 is a Phase 1 study that was terminated before completion, run by BioNTech SE. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04382898, a Phase 1 study, was terminated before completion, sponsored by BioNTech SE.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
Open-label, multicenter, dose titration and four-arm expansion trial to evaluate the safety, tolerability, immunogenicity, and preliminary efficacy of BNT112 cancer vaccine (BNT112) monotherapy or in combination with cemiplimab in patients with metastatic castration resistant prostate cancer (mCRPC: Part 1 and Part 2 Arms 1A and 1B) and in patients with high-risk, localized prostate cancer (LPC). As of February 2023, the trial only recruited LPC patients and no longer mCRPC patients.
Primary Outcome
DLT criteria were defined as following: any treatment-emergent adverse events (TEAE) of Grade 5 intensity; hematological toxicities (Grade 3 and 4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 and 4 hemorrhage associated with thrombocytopenia of Grade greater than or equal to \[\>=\] 3, Grade 4 anemia); and non-hematological toxicities (Grade 4 cytokine release syndrome \[CRS\], Grade 3 CRS which has not improved to Grade 1 or resolved within 48 hours; any Grade \>=3 non-hematological T
Interventions
- DRUG Cemiplimab
- BIOLOGICAL BNT112
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2024-01-23 |
| Phase | Phase 1 |
Why NCT04382898 stopped before completion
NCT04382898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 2 interventions - of which Cemiplimab is the first listed.
NCT04382898 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04382898 about?
NCT04382898 is a clinical study titled "PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)". Open-label, multicenter, dose titration and four-arm expansion trial to evaluate the safety, tolerability, immunogenicity, and preliminary efficacy of BNT112 cancer vaccine (BNT112) monotherapy or in combination with cemiplimab in patients with metastatic castration resistant prostate cancer (mCRPC:...
What is the current status of trial NCT04382898?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2019-12-19. Estimated completion is 2024-01-23.
What interventions are being tested in trial NCT04382898?
The interventions under investigation include: Cemiplimab (DRUG), BNT112 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04382898?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04382898's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 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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