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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

10 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

V940 – V940 is administered as an injection and is currently being studied in clinical trials for its potential use in treating high-risk non-muscle invasive bladder cancer. It is being tested in combination with BCG (Bacillus Calmette-Guérin) therapy, which is a standard treatment for this type of cancer. The main goal of V940 is to improve the effectiveness of BCG therapy by enhancing the immune system's ability to fight cancer cells. At the molecular level, V940 works by stimulating the body's immune response to target and destroy cancer cells more effectively. It is classified as an immunotherapy, which is a type of treatment that uses the body's own immune system to help fight cancer.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517335-46-00Protocol codeV940-011Estimated enrolment309 patientsSponsorMerck Sharp & Dohme LLC

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