NCT04382898

PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)

First-in-human, Dose Titration and Expansion Trial to Evaluate Safety, Immunogenicity and Preliminary Efficacy of W_pro1 (BNT112) Monotherapy and in Combination With Cemiplimab in Patients With Prostate Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* BNT112 consisted of messenger ribonucleic acid (mRNA \[or RNA\]) targeting 5 antigens expressed in de novo and metastatic prostate cancer that were separately complexed with liposomes to form serum-stable RNA lipoplexes (RNA-LPX). * The RNA molecules were immune-pharmacologically optimized for high stability, translational efficiency and presentation on major histocompatibility complex (MHC) class I and II molecules. The vaccine was intended for intravenous (IV) bolus injection. * The RNA-LPX cancer vaccine induced activation of both the adaptive immune system (vaccine antigen-specific CD8+/CD4+ T cell) as well as the innate immune system (TLR7 agonism of single-stranded RNA). The physiology of efficient induction, expansion and differentiation of antigen-specific T cells was associated with programmed death receptor-1 (PD-1) upregulation on these T cells. Thus, the cancer vaccine was expected to have a synergistic mechanism of action with anti-PD-1. * The step-up dose titration approach allowed for optimal dose management on an individual basis and accounted for inter- and intra-individual variability of the immune system. * In summary, the mechanism of action of BNT112 both in monotherapy and in combination with anti-PD-1 immune checkpoint inhibitor cemiplimab, together with carefully selected and refined clinical setting presented a unique opportunity for patients with different stages of prostate cancer.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BNT112	Intravenous bolus injection
DRUG	Cemiplimab	Intravenous infusion

Timeline

• Start date: 2019-12-19
• Primary completion: 2024-01-23
• Completion: 2024-01-23
• First posted: 2020-05-11
• Last updated: 2025-03-20
• Results posted: 2025-03-20

Locations

22 sites across 4 countries: United States, Germany, Hungary, United Kingdom

Regulatory

• FDA-regulated drug study