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

Fast replyRegistered 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 a type of bladder cancer known as High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC). This form of cancer affects the bladder but does not invade the muscle layer. The study is investigating the effectiveness and safety of a treatment that combines two medications: Pembrolizumab and Bacillus Calmette-Guérin (BCG). Pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system fight cancer cells. BCG is a vaccine that is used to treat bladder cancer by stimulating the immune system to attack cancer cells in the bladder.

The purpose of the study is to compare the results of using Pembrolizumab with BCG against using BCG alone in patients with HR NMIBC. Participants in the study will be divided into different groups. Some will receive the combination of Pembrolizumab and BCG, while others will receive only BCG. The study will observe how well the cancer responds to these treatments and how long patients remain free of cancer events. The study will also monitor the overall health and quality of life of the participants during the treatment period.

Participants will receive the treatments over a period of time, with regular check-ups to monitor their health and the progress of the cancer. The study aims to provide valuable information on whether the combination of Pembrolizumab and BCG is more effective than BCG alone in treating HR NMIBC. This research could lead to improved treatment options for patients with this type of bladder cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, participants will be assigned to one of two groups. One group will receive a combination of pembrolizumab and bacillus calmette-guérin (BCG), while the other group will receive BCG alone. This assignment is random and is done to compare the effectiveness of the treatments.

  2. Step 2

    Treatment administration

    Participants receiving pembrolizumab will have it administered through an intravenous infusion. This means the medication is given directly into a vein. The dosage is 25 mg/mL and the frequency and duration will be determined by the study protocol.

    Participants receiving BCG will have it administered intravesically. This means the medication is placed directly into the bladder through a catheter. The frequency and duration of this treatment will also be determined by the study protocol.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, participants will undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects. This may include physical exams, blood tests, and imaging studies.

    Participants will be required to provide tissue samples for biomarker analysis, which helps in understanding how the treatment is working.

  4. Step 4

    End of treatment

    After completing the treatment phase, participants will continue to be monitored for a specified period to evaluate long-term effects and outcomes. This may include follow-up visits and additional tests as needed.

Who can join the trial?

9 criteria

  • Must have a confirmed diagnosis of high-risk non-muscle invasive bladder cancer. This means the cancer is in the bladder but has not spread to the muscle layer.
  • Must have had a procedure called cystoscopy or transurethral resection of bladder tumor (TURBT) to remove any visible tumors. These are procedures to look inside the bladder and remove tumors.
  • Must provide a sample of tissue for biomarker analysis. This is a test to look for specific markers in the tissue that can help guide treatment.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, 1 means some symptoms but nearly fully active, and 2 means unable to work but can take care of themselves.
  • Must have adequate organ function. This means the organs in the body are working well enough to handle the treatment.
  • Male participants must either not engage in heterosexual intercourse or agree to use contraception during the treatment and for at least 7 days after the last dose of BCG, unless they are confirmed to be azoospermic (unable to produce sperm).
  • Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use a highly effective method of contraception or remain abstinent from heterosexual intercourse during the treatment and for at least 7 days after the last dose of BCG or 120 days after the last dose of pembrolizumab, whichever is longer.
  • For BCG Post-induction Cohort (Cohort A) only: Must have been treated with an adequate course of BCG induction therapy, which is a type of treatment for bladder cancer.
  • For BCG Post-induction Cohort (Cohort A) only: After receiving BCG induction therapy, must have persistent or recurrent high-risk non-muscle invasive bladder cancer.

Who cannot join the trial?

10 criteria

  • Patients with a history of severe allergic reactions to the study drugs cannot participate.
  • Patients who have received another investigational drug within the last 4 weeks are not eligible.
  • Patients with an active infection that requires treatment with antibiotics are excluded.
  • Patients with a known history of **HIV** (Human Immunodeficiency Virus) infection are not allowed to join the study.
  • Patients with **hepatitis B** or **hepatitis C** infections cannot participate. These are viral infections that affect the liver.
  • Patients with any other cancer that is progressing or requires treatment are excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients with a history of autoimmune disease, which is when the body's immune system attacks its own tissues, are not eligible.
  • Patients who have had a major surgery within the last 4 weeks are excluded.
  • Patients with a history of heart problems, such as heart attack or heart failure, are not allowed to participate.
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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 help treat high-risk non-muscle invasive bladder cancer, especially in cases where the cancer is persistent or has come back after initial treatment, or in patients who have not been treated with BCG before.

  • Bacillus Calmette-Guerin (BCG)

    is a type of therapy that uses a live, but weakened, form of bacteria to stimulate the immune system. It is commonly used to treat bladder cancer by being placed directly into the bladder. In this trial, BCG is being used alone and in combination with pembrolizumab to see if the combination is more effective in treating high-risk non-muscle invasive bladder cancer.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently being studied in clinical trials for its effectiveness and safety in treating high-risk non-muscle invasive bladder cancer, particularly in cases where the cancer is persistent, recurrent, or has not been treated with BCG before. 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 target and destroy cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

  • Bacillus Calmette-Guerin (BCG)

    BCG is administered directly into the bladder through a catheter, a process known as intravesical therapy. It is a well-established treatment in the medical field for bladder cancer, particularly for high-risk non-muscle invasive bladder cancer. The main therapeutic indication for BCG is to prevent the recurrence and progression of bladder cancer. It works by stimulating the immune system to attack cancer cells in the bladder. BCG is classified as an immunotherapy, which means it uses the body's own immune system to help fight cancer.

Investigated diseases

High Risk Non-muscle Invasive Bladder Cancer – This type of bladder cancer is characterized by the presence of cancerous cells in the bladder lining that have not yet invaded the muscle layer. It is considered high risk due to factors such as the presence of carcinoma in situ (CIS), high-grade tumors, or frequent recurrence. The disease often begins with symptoms like blood in the urine, frequent urination, or pain during urination. As it progresses, there is a risk of the cancer spreading deeper into the bladder wall or to other parts of the body. Monitoring and regular check-ups are crucial to manage the disease and prevent progression. The condition requires careful observation to detect any changes in the tumor's behavior.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501817-29-00Protocol codeMK-3475-676Estimated enrolment1 397 patientsSponsorMerck Sharp & Dohme LLC

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