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Cancer Vaccine

Cancer Vaccine + Cemiplimab for Prostate Cancer (PRO-MERIT Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have at least 1 of the following: PSA >20 ng/mL, Gleason Score >7, or Localized stage ≥cT2c, N0, M0 according to tumor, node, metastasis classification.
Treatment-naïve patients with LPC according to risk levels of the European Association of Urology Guidelines on Prostate Cancer and U.S. National Comprehensive Cancer Network (NCCN 2020).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

PRO-MERIT Trial Summary

This trial is testing a new cancer vaccine in patients with mCRPC or high-risk LPC to see if it is safe and effective.

Who is the study for?
This trial is for men aged 18 or older with confirmed prostate cancer. It's specifically for those with high-risk, localized prostate cancer who are planning a radical prostatectomy and have not received certain treatments like systemic corticosteroids or immunomodulating agents recently. Men must be in good physical condition (ECOG PS score of 0 or 1) and agree to provide tumor samples.Check my eligibility
What is being tested?
The PRO-MERIT trial is testing the BNT112 cancer vaccine alone or combined with cemiplimab in patients. The study will look at how safe these treatments are, how well they work, and what kind of immune response they create against metastatic castration-resistant and high-risk localized prostate cancers.See study design
What are the potential side effects?
Potential side effects may include typical reactions to vaccines such as soreness at the injection site, fever, fatigue, as well as more serious immune-related responses due to cemiplimab which could affect organ function.

PRO-MERIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer has a high PSA level, Gleason Score, or is at an advanced localized stage.
Select...
I have untreated low-risk prostate cancer according to major guidelines.
Select...
My prostate cancer has been confirmed through a tissue examination.
Select...
I am a man and I am 18 years old or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have undergone castration and my testosterone level is below 1.7 nmol/L.

PRO-MERIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR) - Part 2 Arms 1A and 1B
Occurrence of dose limiting toxicities (DLTs)
Occurrence of treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Change in PSA doubling time (PSADT)
Change in prostate-specific antigen (PSA) levels
ORR - Part 1
+1 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267
25%
Anaemia
20%
Nausea
17%
Fatigue
16%
Vomiting
15%
Decreased appetite
15%
Constipation
11%
Asthenia
11%
Back pain
11%
Pyrexia
11%
Diarrhoea
10%
Arthralgia
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) Chemotherapy

PRO-MERIT Trial Design

6Treatment groups
Experimental Treatment
Group I: Part 2 Arm 3 (LPC) - expansion cohortExperimental Treatment1 Intervention
BNT112 monotherapy
Group II: Part 2 Arm 2 (LPC) - expansion cohortExperimental Treatment2 Interventions
BNT112 in combination with cemiplimab
Group III: Part 2 Arm 1B [2] (mCRPC) - expansion cohortExperimental Treatment1 Intervention
Following progression after BNT112 monotherapy, patients in Arm 1b have the option to be treated with cemiplimab monotherapy Enrollment into this arm is completed.
Group IV: Part 2 Arm 1B [1] (mCRPC) - expansion cohortExperimental Treatment1 Intervention
BNT112 monotherapy Enrollment into this arm is completed.
Group V: Part 2 Arm 1A (mCRPC) - expansion cohortExperimental Treatment2 Interventions
BNT112 in combination with cemiplimab Enrollment into this arm is completed.
Group VI: Part 1 (mCRPC) - dose titrationExperimental Treatment1 Intervention
BNT112 monotherapy Enrollment into this arm is completed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor
64 Previous Clinical Trials
109,106 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
33 Previous Clinical Trials
9,681 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions can be ameliorated with BNT112?

"BNT112 has shown promise in managing alk gene mutation, completing advance directives, and treating malignant neoplasms."

Answered by AI

Are there other research projects that have utilized BNT112?

"Presently, 56 investigations are researching BNT112 and 4 of the active clinical trials have reached Phase 3. Though the majority take place in Barcelona and California, there is a total of 1738 sites running studies for this medication."

Answered by AI

How many participants are engaged in this research project?

"At this time, recruitment for this medical study has been closed. It was initially posted on 19th December 2019 and the most recent update to it took place on 6th October 2022. If you are looking into other trials, there are presently 1320 studies actively enrolling patients with prostate cancer as well as 56 clinical trials involving BNT112 that have open enrollment."

Answered by AI

Are participants being accepted for this research endeavor?

"Recruitment for this trial has ceased. It was initially announced on December 19th, 2019 with the last revision taking place October 6th, 2022. If you are looking for other research opportunities, there are presently 1320 studies admitting patients with prostate cancer and 56 trials recruiting participants to receive BNT112."

Answered by AI

How many research centers are administering this trial in North America?

"Virginia Cancer Specialists in Fairfax, Virginia, Yale University in New Haven, Connecticut and Virgina Cancer Specialists in Pittsburgh Pennsylvania are amongst the 9 sites running this clinical trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)
2019. "PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04382898.
~14 spots leftby Apr 2025
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