drugset / Trial / NCT04382898
PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)
RandomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2019-12-19
- Primary completion
- 2024-01-23
- Completion
- 2024-01-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BNT112 | Unknown | — | Intravenous |
| Subject | Cemiplimab | Monoclonal antibody | — | Intravenous |