Study of mRNA-4157 and BCG for Patients with High-Risk Non-Muscle Invasive Bladder Cancer

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What is this study about?

This clinical trial is focused on studying treatments for bladder cancer, specifically a type known as high-risk non-muscle invasive bladder cancer. The study will explore the effects of two treatments: the BCG vaccine and a new investigational drug called mRNA-4157. The BCG vaccine is a well-known treatment used to prevent the recurrence of bladder cancer, while mRNA-4157 is a new type of treatment that uses a synthetic form of genetic material to help the body fight cancer cells.

The purpose of the study is to compare the effectiveness of using mRNA-4157 in combination with the BCG vaccine against using the BCG vaccine alone. Participants will be randomly assigned to receive either the combination of mRNA-4157 and BCG or just the BCG vaccine. The study will also look at how well mRNA-4157 works on its own. The treatments will be given over a period of time, and participants will be monitored to see how their cancer responds to the treatments.

Throughout the study, participants will receive regular check-ups to monitor their health and the progress of their cancer. The study aims to provide valuable information on whether the combination of mRNA-4157 and BCG can improve outcomes for people with high-risk non-muscle invasive bladder cancer compared to the BCG vaccine alone. This research could lead to new treatment options for patients with this type of bladder cancer.

1 joining the study

Upon joining the study, you will be assigned to one of two groups. One group will receive a combination of V940 and BCG treatments, while the other group will receive BCG treatment alone. This assignment is random and is an important part of the study design.

2 treatment administration

If you are in the combination group, you will receive V940 and BCG treatments. V940 is administered through an injection into the muscle, known as intramuscular injection. BCG is administered directly into the bladder, known as intravesical use.

If you are in the BCG monotherapy group, you will receive BCG treatment only, administered directly into the bladder.

3 treatment schedule

The schedule for receiving the treatments will be explained to you by the study team. It is important to follow the schedule as closely as possible to ensure the effectiveness of the treatment.

4 monitoring and follow-up

Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment. This may include providing blood samples and undergoing various tests as specified by the study protocol.

You will be asked to provide a tumor tissue sample for analysis. This helps in understanding how the treatment is working.

5 end of study participation

Your participation in the study will continue until the study ends or until it is determined that you should stop for health reasons. The study is expected to end by August 12, 2031.

At the end of your participation, you will have a final check-up to assess your health and discuss any further steps if necessary.

Who Can Join the Study?

The patient must have had their most recent surgery to remove a bladder tumor, called a transurethral resection of bladder tumor (TURBT), within 12 weeks before joining the study. This surgery must have shown a type of bladder cancer called high-risk non-muscle invasive bladder cancer (NMIBC).
For Cohort A: The patient must be BCG-naïve, meaning they have either never received a treatment called Bacillus Calmette–Guérin (BCG) or they received it more than 2 years before their high-risk NMIBC came back. The cancer must have returned at least 24 months after the last BCG treatment, with no signs of cancer during the 2-year period after BCG.
For Cohort B: The patient can be either BCG-naïve (as described above) or have had some BCG treatment but not enough, and their high-risk NMIBC returned within 2 years of the last BCG dose.
The patient must be able to provide a sample of their tumor tissue that is suitable for a test called Next-Generation Sequencing (NGS) and also provide blood samples as required by the study.
The patient must have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 14 days before joining the study. This scale measures how well a patient can perform daily activities.
For Cohort B only: If the patient is infected with human immunodeficiency virus (HIV), their HIV must be well controlled with medication called antiretroviral therapy (ART).
If the patient tests positive for hepatitis B surface antigen (HBsAg), they are eligible if they have been on hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have an undetectable HBV viral load before joining the study.
The study is open to both male and female patients.

Who Cannot Join the Study?

Patients with any other type of cancer besides bladder cancer cannot participate.
Patients who have had a different cancer in the past, unless it was treated and has not come back for at least 5 years, cannot participate.
Patients who are currently receiving any other cancer treatment cannot participate.
Patients with a weakened immune system, which means their body cannot fight infections well, cannot participate.
Patients who have an active infection that needs treatment with antibiotics cannot participate.
Patients who have had a major surgery within the last 4 weeks cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of severe allergic reactions cannot participate.
Patients who are participating in another clinical trial cannot participate.
Patients who have any other medical condition that the study doctors think would make it unsafe for them to participate cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
University Hospital Jena KöR	Jena	Germany
Hospital Clinico San Carlos	Madrid	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Hospital Foch	Suresnes	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Henry Dunant Hospital Center	Athens	Greece
University Of Debrecen	Debrecen	Hungary
Hospital Universitario Virgen Macarena	Sevilla	Spain
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A	Cholargos	Greece
Odense University Hospital	Odense	Denmark
Klinikum Der Landeshauptstadt Stuttgart gKAöR	Stuttgart	Germany
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza	Hungary
Markhot Ferenc Oktatokorhaz Es Rendelointezet	Eger	Hungary
Szpital Wojewodzki Im. Sw. Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie	Tarnow	Poland
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr	Herne	Germany
Azienda USL Toscana Sud Est	Arezzo	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
University Of Szeged	Szeged	Hungary
Ipkzrm Iqcsvqxn Fagdbdngjxfhs Ocofrdybqwj	Rome	Italy
Rfogpwido Zdlqdtypxt Sjcpsawup	Arnhem	The Netherlands
Pbbm Tekak Hlrgjieo Ujdodhvecoyo	Sabadell	Spain
Hthyut Hnuacqux	Herlev	Denmark
Cisxgw Hpvjfkquywo Uvyckgjcjsftj Dr Dvjav	Dijon	France
Amssvvvypc Pqpdsacb Hvtnlijc Dr Psbeb	Paris	France
Etwzxvl Ucdfmragwisa Mvfqogq Cmltziq Rkbojljij (iyjtcsz Mvd	Rotterdam	The Netherlands
Gmwydxsnligxszske Vzxpkhcui Pwfm Azjgye Eoetggqf Osiwbt Kfrham	Gyor	Hungary
Ahbzga Myfeqgq Cvepzz Sszh	Thessaloniki	Greece
Nuxojegl Idmvqutk Owwmckobk Ibq Mrsgc Slmrwnohhschxkwhrnbquwsxzapl Ignvardp Brlickub	Cracow	Poland
Kzlitnzm dcv Uunnqhxekhyh Mfocsxil Aul	Munich	Germany
Mhmkovlrpnbofedlfytjssyapm Hmlzojudtvishzin	Halle (Saale)	Germany
Uiznunznni Gxkuxni Hskvwaml Aasatwi	Athens	Greece

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	11.08.2025
France	Recruiting	11.08.2025
Germany	Recruiting	11.08.2025
Greece	Recruiting	11.08.2025
Hungary	Recruiting	11.08.2025
Italy	Recruiting	11.08.2025
Poland	Recruiting	11.08.2025
Spain	Recruiting	11.08.2025
The Netherlands	Recruiting	11.08.2025

Trial locations

Investigated drugs:

Mrna-4157

V940 is an experimental medication being tested in this clinical trial. It is being studied to see if it can help treat high-risk non-muscle invasive bladder cancer. In this trial, V940 is being used in two different ways: in combination with another treatment called BCG, and on its own. The goal is to see if V940 can improve outcomes for patients, either by itself or when used with BCG.

BCG stands for Bacillus Calmette-Guérin, which is a type of immunotherapy used to treat bladder cancer. It works by stimulating the body’s immune system to attack cancer cells in the bladder. In this trial, BCG is being used both alone and in combination with V940 to see if the combination can provide better results for patients with high-risk non-muscle invasive bladder cancer.

Investigated diseases:

Bladder cancer

Bladder cancer – Bladder cancer is a disease where abnormal cells grow uncontrollably in the bladder, a hollow organ in the lower abdomen that stores urine. It often begins in the urothelial cells that line the inside of the bladder. As the disease progresses, it can invade deeper layers of the bladder wall and potentially spread to nearby lymph nodes and other organs. The most common symptom is blood in the urine, which may be visible or detectable only through testing. Other symptoms can include frequent urination, pain during urination, and lower back pain. The progression of bladder cancer can vary, with some cases remaining superficial and others becoming more invasive over time.

Trial ID:

2024-517335-46-00

Protocol code:

V940-011

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of mRNA-4157 and BCG for Patients with High-Risk Non-Muscle Invasive Bladder Cancer

What is this study about?

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