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Study of V940 and Pembrolizumab for Patients with High-Risk Muscle-Invasive Bladder Cancer After Surgery

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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 a type of cancer called muscle-invasive urothelial carcinoma, which affects the bladder and other parts of the urinary system. The study is looking at patients who have a high risk of the cancer returning after they have had surgery to remove it. The trial will test a new treatment combination of two medications: V940 (also known as mRNA-4157) and pembrolizumab (also known as Keytruda). V940 is a type of treatment that uses a small piece of genetic material to help the body recognize and fight cancer cells. Pembrolizumab is a medication that helps the immune system attack cancer cells more effectively.

The purpose of the study is to compare the effectiveness of V940 plus pembrolizumab against a placebo plus pembrolizumab in preventing the cancer from coming back. Participants in the study will be randomly assigned to receive either the new treatment combination or the placebo combination. The study will be conducted in a way that neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results. The treatment will be given over a period of time, and participants will be monitored regularly to check for any changes in their health and to see how well the treatment is working.

Throughout the study, the main focus will be on measuring how long participants remain free from cancer, known as disease-free survival. Other aspects being monitored include overall survival, the time until cancer spreads to other parts of the body, and any side effects experienced by participants. The study aims to provide valuable information on whether the new treatment combination can offer better outcomes for patients with high-risk muscle-invasive urothelial carcinoma.

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, the patient is required to provide a tumor tissue sample and blood samples. These samples are used for specific tests and to produce the study medication, V940.

    The patient must have a performance status assessment to ensure they meet the study's health criteria.

  2. Step 2

    Randomization

    The patient is randomly assigned to one of two groups. One group receives V940 plus pembrolizumab, and the other group receives a placebo plus pembrolizumab.

  3. Step 3

    Treatment administration

    The patient receives pembrolizumab through an intravenous infusion. This is a solution administered directly into the bloodstream.

    If assigned to the V940 group, the patient also receives V940 through an intramuscular injection. This is a dispersion injected into the muscle.

  4. Step 4

    Monitoring and follow-up

    The patient's health is monitored throughout the study to assess disease-free survival and other health outcomes.

    The study also tracks any adverse events or side effects experienced by the patient.

  5. Step 5

    Completion of the study

    The study is estimated to end in May 2032. The patient will continue to be monitored until the study's conclusion.

Who can join the trial?

6 criteria

  • The patient must have a condition called muscle-invasive urothelial carcinoma (MIUC), which is a type of bladder cancer that has spread into the muscle layer of the bladder.
  • The patient must have a dominant type of cancer tissue called urothelial carcinoma (UC).
  • The patient must have a high-risk form of the disease after having surgery to remove the cancer.
  • The patient must provide a sample of their tumor tissue, which has been preserved in a special way called formalin-fixed paraffin-embedded (FFPE), for advanced genetic testing.
  • The patient must provide blood samples as required by the study. These samples will be used to produce a treatment called V940 and to test for circulating tumor DNA (ctDNA), which is DNA from cancer cells found in the blood.
  • The patient must have a performance status score between 0 and 2, according to the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well a patient can perform daily activities. This assessment must be done within 7 days before joining the study.

Who cannot join the trial?

10 criteria

  • Patients who have not fully recovered from previous cancer treatments.
  • Patients with other active cancers that are not under control.
  • Patients with severe heart problems.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that require treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of severe allergic reactions to similar medications.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body.
  • Patients who have received an organ transplant.
  • Patients with a history of drug or alcohol abuse.
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Investigated drugs

  • V940 (mRNA-4157)

    is an investigational treatment being studied to see if it can help the immune system fight cancer. It is designed to work by teaching the body to recognize and attack cancer cells. In this trial, it is being tested in combination with another medication to see if it can improve outcomes for patients with a specific type of bladder cancer.

  • Pembrolizumab

    is a medication that helps the immune system detect and fight cancer cells. It is already used in the treatment of various cancers and works by blocking a specific pathway that cancer cells use to hide from the immune system. In this trial, it is being used alongside V940 to see if the combination is more effective than using pembrolizumab alone.

What is already known about the treatment

  • V940 (mRNA-4157)

    This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating high-risk muscle-invasive urothelial carcinoma after radical resection. It is an investigational mRNA-based therapy designed to stimulate the immune system to target cancer cells. The main therapeutic indication is to improve disease-free survival in patients with this type of cancer. V940 works by encoding specific proteins that help the immune system recognize and attack cancer cells, classifying it as an immunotherapy agent.

  • Pembrolizumab

    This medication is administered as an intravenous infusion and is widely used in medicine for various types of cancer, including high-risk muscle-invasive urothelial carcinoma. It is an immune checkpoint inhibitor that helps the immune system detect and fight cancer cells. The main therapeutic indication is to enhance the body's immune response against cancer. Pembrolizumab works by blocking the PD-1 pathway, which cancer cells use to hide from the immune system, thus allowing immune cells to attack the cancer. It is classified as an immunotherapy drug.

Investigated diseases

High-risk Muscle-invasive Urothelial Carcinoma Post-radical Resection – This is a type of bladder cancer that has spread into the muscle layer of the bladder wall. After surgical removal of the bladder, the disease is considered high-risk due to the potential for cancer cells to remain or spread to other parts of the body. The progression of this disease can involve the cancer returning or metastasizing to distant organs. Monitoring for recurrence is crucial, as the disease can be aggressive. The focus is often on preventing the cancer from coming back and managing any spread that may occur.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505658-17-00Protocol codeV940-005Estimated enrolment237 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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