PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)

Stopped early · Phase 1/Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04382898

Run by

BioNTech SE

People needed

75

Starts

2019-12-19

Expected to finish

2024-01-23

Last updated by the study team

2025-03-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients were male and aged >=18 years.
• Patients had histologically confirmed prostate adenocarcinoma.
• Patients had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
• Specific key inclusion criteria for mCRPC patients (Part 1 and Part 2 Arms 1A and 1B) - Recruitment of mCRPC patients now completed:
• Patients had histologically confirmed mCRPC and had progressed after at least 2 but no more than 3 lines of life-prolonging systemic therapy (e.g., abiraterone or enzalutamide, docetaxel, cabazitaxel) or cannot tolerate or refused any of these therapies. These lines of therapy included life-prolonging therapies administered in the metastatic hormone-sensitive setting.
• Prior surgical or chemical castration with a serum testosterone <1.7 nmol/L (50 ng/dL). If the method of castration was luteinizing hormone-releasing hormone analogue (LHRHa), there was a plan to maintain effective LHRHa therapy for the duration of the trial.
• Patients had documented mCRPC progression within 6 months prior to screening (assuming no subsequent change in treatments), as determined by the investigator.
• Patients agreed to provide an archival pre-treatment formalin-fixed, paraffin-embedded tumor sample if available.
• Specific key inclusion criteria for newly diagnosed LPC patients (Part 2 Arms 2 and 3):
• Treatment-naïve patients with LPC (i.e., N0, M0). According to risk levels of the European Association of Urology Guidelines on Prostate Cancer (2018), and in line with the U.S. National Comprehensive Cancer Network (NCCN 2020), patients had at least 1 of the following:
• PSA >20 ng/mL or
• Gleason Score >7 or
• Localized stage >=cT2c, N0, M0 according to tumor, node, metastasis classification.
• Patients who intend to have and were suitable for a radical prostatectomy.
• Patients agreed to provide tumor sample(s) from pre-treatment diagnostic biopsy and planned post-treatment surgery.
• Main exclusion criteria for all patients:
• Medical conditions
• Patients with uncontrolled intercurrent illness.
• Patients with a known history or current malignancy other than the inclusion diagnosis. Note: Exceptions were patients with malignancies with a negligible risk of metastasis or death, that had been adequately treated, such as non-invasive basal cell or non-invasive squamous cell skin carcinoma, non-invasive, superficial bladder cancer, and any cancer with a complete response (CR) that lasted more than 2 years might be included.
• Patients who had major surgery (e.g., requiring general anesthesia) within 4 weeks before screening, or have not fully recovered from surgery, or had a surgery planned during the time of trial participation, except for the radical prostatectomy planned for patients in Part 2 Arms 2 and 3.
• Patients who had a known history of any of the following:
• Human immunodeficiency virus (HIV) 1 or 2
• Hepatitis B (carrier or active infection)
• Hepatitis C (unless considered cured 5 years post curative anti-viral therapy)
• Patients who have received or currently receive the following therapy/treatment:

Where it is running

• The University of Arizona Cancer Center — Tucson, Arizona, United States
• University of Miami Hospital & Clinics /Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• University of Pittsburgh Cancer Inst. — Pittsburgh, Pennsylvania, United States
• Urology San Antonio P.A. — San Antonio, Texas, United States
• University of Virginia Cancer Center — Charlottesville, Virginia, United States
• Universitätsklinikum Bonn — Bonn, Germany
• Klinikum der Johann Wolfgang Goethe-Universität — Frankfurt, Germany
• Universitätsklinikum Münster — Münster, Germany
• Studienpraxis Urologie — Nürtingen, Germany
• Urologische Klinik Planegg — Planegg, Germany
• Universitätsklinikum Tübingen — Tübingen, Germany
• Magyar Honvédség Egészségügyi Központ (MH EK Honvédkórház) — Budapest, Hungary
• Semmelweis Egyetem, Belgyógyászati Klinika — Budapest, Hungary
• Onkológiai Klinika — Debrecen, Hungary
• Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház — Nyíregyháza, Hungary
• Szent Borbála Kórház — Tatabánya, Hungary
• Cancer Research UK Cambridge Centre — Cambridge, United Kingdom
• Velindre Cancer Centre (VCC) — Cardiff, United Kingdom
• University of Glasgow, Beatson WoS Cancer Centre — Glasgow, United Kingdom
• University College London Hospitals — London, United Kingdom
• The Royal Marsden Hospital — London, United Kingdom
• University Hospital Southampton - Southampton General Hospital — Southampton, United Kingdom

Full record on ClinicalTrials.gov

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