Spots Global Cancer Trial Database for PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)

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Trial Identification

Brief Title: PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)

Official Title: 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

Study ID: NCT04382898

Conditions

Prostate Cancer

Interventions

BNT112

Cemiplimab

Study Description

Brief 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 will be only recruiting LPC patients and no longer mCRPC patients.

Detailed Description: * BNT112 consists of messenger ribonucleic acid (mRNA \[or RNA\]) targeting 5 antigens expressed in de novo and metastatic prostate cancer that are separately complexed with liposomes to form serum-stable RNA lipoplexes (RNA-LPX). * The RNA molecules are immune-pharmacologically optimized for high stability, translational efficiency and presentation on major histocompatibility complex (MHC) class I and II molecules. The vaccine is intended for intravenous (IV) bolus injection. * The RNA-LPX cancer vaccine induces 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 is associated with programmed death receptor-1 (PD-1) upregulation on these T cells. Thus, the cancer vaccine is expected to have a synergistic mechanism of action with anti-PD-1. * 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 presents a unique opportunity for patients with different stages of prostate cancer.