Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Vaccines

Immunomodulating Agents

Cemiplimab

Antineoplastic Agents, Immunological

BNT112 monotherapy

Enrollment into this arm is completed.

BNT112 in combination with cemiplimab

Enrollment into this arm is completed.

Following progression after BNT112 monotherapy, patients in Arm 1b have the option to be treated with cemiplimab monotherapy

Enrollment into this arm is completed.

BNT112

BioNTech Responsible Person

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.

* 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.

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

Occurrence of TEAEs reported by relationship, grade, and seriousness according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0).

ORR, defined as the number of patients with a complete response (CR) or partial response (PR) per Prostate Cancer Working Group 3 (PCWG3).

PSA decline of 0 to 25%, \>25% to 50%, and \>50% compared to baseline, as well as PSA decline ≥ 50% according to PCWG3.

PSADT during treatment and end of treatment (EoT) compared to baseline.

ORR, defined as the number of patients with a CR or PR per PCWG3.

Evaluate preliminary anti-tumor activity of BNT112 monotherapy or in combination with cemiplimab in patients with newly diagnosed LPC.

Spots Global Cancer Trial Database for w pro1

Every month we try and update this database with for w pro1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for w pro1

Every month we try and update this database with for w pro1 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for w pro1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.