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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 is a Phase 1 study that was terminated before completion, run by BioNTech SE. The registered enrollment target is 75 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04382898
The ClinicalTrials.gov registry entry for NCT04382898 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cemiplimab is the first listed.
NCT04382898 reports 0 study locations.
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.
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