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Study of Pembrolizumab with Chemoradiotherapy for Patients with Muscle-Invasive Bladder Cancer

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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 bladder cancer. The study is investigating the effectiveness and safety of a treatment called pembrolizumab, also known by its code name MK-3475, when used in combination with chemoradiotherapy. Chemoradiotherapy is a treatment that combines chemotherapy, which uses drugs to kill cancer cells, and radiation therapy, which uses high-energy rays to target and destroy cancer cells. The study will compare this combination treatment to chemoradiotherapy alone.

Participants in the study will receive either pembrolizumab with chemoradiotherapy or a placebo with chemoradiotherapy. A placebo is a substance with no active drug, used to compare the effects of the actual treatment. The chemotherapy drugs used in this study include fluorouracil, gemcitabine hydrochloride, cisplatin, and mitomycin. These drugs are administered through an intravenous infusion, which means they are given directly into a vein. The purpose of the study is to see if the combination of pembrolizumab and chemoradiotherapy can improve outcomes for patients with muscle-invasive bladder cancer.

The study will take place over a period of time, during which participants will undergo regular assessments to monitor their health and the effectiveness of the treatment. These assessments may include procedures like cystoscopy, which is a test that allows doctors to look inside the bladder, and various imaging tests. The study aims to determine if the combination treatment can help patients live longer without the cancer returning or spreading, and to evaluate the overall survival and quality of life of the participants.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the diagnosis of muscle-invasive bladder cancer is accurate and that the cancer has not spread beyond the bladder.

  2. Step 2

    Randomization

    Participants will be randomly assigned to one of two groups. One group will receive pembrolizumab in combination with chemoradiotherapy, while the other group will receive a placebo with chemoradiotherapy. This process is double-blind, meaning neither the participants nor the researchers will know which group each participant is in.

  3. Step 3

    Treatment administration

    Participants in the pembrolizumab group will receive pembrolizumab through an intravenous infusion. The dosage is 25 mg/mL, and the frequency and duration will be determined by the study protocol.

    Chemoradiotherapy will include medications such as fluorouracil, gemcitabine hydrochloride, cisplatin, and mitomycin, all administered via intravenous infusion. The specific dosage and schedule will be provided by the healthcare team.

  4. Step 4

    Regular monitoring

    Throughout the trial, regular monitoring will occur to assess the effectiveness and safety of the treatment. This includes cystoscopy, biopsy if necessary, urine tests, and imaging studies. These assessments help determine the response to treatment and monitor for any side effects.

  5. Step 5

    Follow-up visits

    Participants will have scheduled follow-up visits to track progress and manage any side effects. These visits are crucial for ensuring the safety and well-being of participants and for collecting data on the treatment's impact on bladder cancer.

  6. Step 6

    End of treatment

    At the end of the treatment period, a final assessment will be conducted to evaluate the overall response to the therapy. This includes a comprehensive review of all test results and any changes in health status.

  7. Step 7

    Long-term follow-up

    Participants may be asked to continue with long-term follow-up visits to monitor for any late effects of the treatment and to gather additional data on long-term outcomes such as overall survival and quality of life.

Who can join the trial?

7 criteria

  • The patient must have a confirmed diagnosis of muscle-invasive bladder cancer with mostly urothelial histology. This means the cancer has spread into the muscle layer of the bladder and is mainly made up of urothelial cells.
  • The patient must have bladder cancer that has not spread to other parts of the body. This is referred to as nonmetastatic bladder cancer (N0M0).
  • The patient must be planning to receive and be eligible for chemoradiotherapy (CRT), which is a combination of chemotherapy and radiation therapy, and one of the specific chemotherapy regimens that make the radiation work better.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. This is a scale used to assess how the disease affects the daily living abilities of the patient, with 0 being fully active and 2 being capable of all self-care but unable to carry out any work activities.
  • The patient must have adequate organ function, meaning their organs are working well enough to handle the treatment.
  • Male patients must agree to certain conditions during the treatment period and for at least 90 days after the last dose of CRT treatment. They must refrain from donating sperm and either abstain from heterosexual intercourse or use contraception unless they are confirmed to be azoospermic (unable to produce sperm).
  • Female patients must not be pregnant or breastfeeding. They must either not be of childbearing potential or, if they are, they must use a highly effective contraceptive method or abstain from heterosexual intercourse during the treatment period and for at least 180 days after the last dose of treatment. They must also agree not to donate eggs during this period.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than Muscle Invasive Bladder Cancer.
  • Patients who have had a previous treatment for bladder cancer that involved surgery to remove the bladder.
  • Patients who have received chemotherapy or radiation therapy for bladder cancer in the past.
  • Patients with a history of another type of cancer, unless it was treated successfully and has not returned for at least 5 years.
  • Patients with serious heart problems, such as a recent heart attack or heart failure.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that require treatment with antibiotics.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an allergy to the study drugs or similar medications.
  • Patients who are participating in another clinical trial at the same time.
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Investigated drugs

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, pembrolizumab is being tested to see if it can improve the treatment of muscle-invasive bladder cancer when used together with chemoradiotherapy. The goal is to see if this combination can help keep the bladder intact and free from cancer longer than using chemoradiotherapy alone.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating muscle-invasive bladder cancer, often in combination with other treatments like chemoradiotherapy. The main therapeutic use of pembrolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a specific protein on immune cells, which helps the immune system to better detect and destroy cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps boost the body's natural defenses against cancer.

Investigated diseases

Muscle Invasive Bladder Cancer – Muscle Invasive Bladder Cancer is a type of bladder cancer that occurs when cancer cells grow into the muscle layer of the bladder wall. It typically begins in the urothelial cells that line the inside of the bladder. As the disease progresses, the cancer can spread to the surrounding tissues and organs, including the lymph nodes, lungs, liver, and bones. The progression of the disease can lead to symptoms such as blood in the urine, frequent urination, and pain during urination. Over time, the cancer may invade deeper layers of the bladder and potentially metastasize to other parts of the body. The disease requires careful monitoring to assess the extent of invasion and potential spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503500-87-00Protocol codeMK-3475-992Estimated enrolment539 patientsSponsorMerck Sharp & Dohme LLC

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