drugset / Trial / NCT04382898

PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)

NCT04382898

Phase 1/2 Terminated 75 enrolled BioNTech SE
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

EvaluationDrugModalityDoseRoute
Subject BNT112 Unknown Intravenous
Subject Cemiplimab Monoclonal antibody Intravenous

Indications