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Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment

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 muscle-invasive bladder cancer. The study is investigating the effects of a treatment called pembrolizumab, also known by its code name MK-3475, in combination with chemotherapy drugs cisplatin and gemcitabine. Pembrolizumab is a medication that helps the immune system fight cancer cells. The purpose of the study is to compare the effectiveness of pembrolizumab with chemotherapy against a placebo with chemotherapy in patients who are eligible to receive cisplatin.

Participants in the study will be randomly assigned to one of two groups. One group will receive pembrolizumab along with chemotherapy before and after surgery, while the other group will receive a placebo with the same chemotherapy regimen. The study will involve a series of treatments and follow-ups over a period of time to monitor the progress and outcomes of the treatment. The main goal is to see if the combination of pembrolizumab and chemotherapy can improve the time patients remain free from cancer events compared to the placebo group.

Throughout the study, participants will undergo various procedures, including surgery to remove the bladder and nearby lymph nodes, known as radical cystectomy and pelvic lymph node dissection. The study will also track other important outcomes, such as overall survival and the rate of complete response to the treatment. This research aims to provide valuable insights into the potential benefits of using pembrolizumab in treating muscle-invasive bladder cancer.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the experimental treatment or the standard treatment.

  2. Step 2

    Treatment group assignment

    If you are assigned to the experimental group, you will receive pembrolizumab along with chemotherapy. If you are assigned to the standard group, you will receive a placebo along with chemotherapy. A placebo is a substance that looks like the treatment but does not have any active ingredients.

  3. Step 3

    Treatment administration

    The treatment involves receiving medications through an intravenous infusion, which means the medication is given directly into a vein through a needle. This will be done at scheduled times as determined by the study protocol.

  4. Step 4

    Medications and dosage

    If you are in the experimental group, you will receive pembrolizumab (also known as Keytruda) at a concentration of 25 mg/mL. You will also receive chemotherapy drugs, cisplatin and gemcitabine. The exact dosage and frequency will be explained to you by the study team.

  5. Step 5

    Surgery

    After completing the initial treatment phase, you will undergo a surgical procedure called Radical Cystectomy (RC) and Pelvic Lymph Node Dissection (PLND). This surgery involves removing the bladder and nearby lymph nodes to treat bladder cancer.

  6. Step 6

    Follow-up and monitoring

    Following surgery, you will continue to be monitored for any changes in your health. This includes regular check-ups and tests to assess your response to the treatment and to ensure your well-being.

  7. Step 7

    Study completion

    The study is expected to continue until June 2025. During this time, you will be asked to attend follow-up visits and report any side effects or changes in your health to the study team.

Who can join the trial?

6 criteria

  • Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) with predominant (≥50%) urothelial histology. This means the cancer has been confirmed by examining tissue under a microscope and is mainly made up of urothelial cells.
  • Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI)) of the chest/abdomen/pelvis. This means the cancer has not spread to distant parts of the body, as shown by scans.
  • Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND). This means the patient is considered suitable for surgery to remove the bladder and nearby lymph nodes.
  • Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Have adequate organ function. This means the patient's organs, such as the liver and kidneys, are working well enough to participate in the study.
  • Male and female participants are eligible to participate if they agree to the contraception use as per study protocol. This means participants must agree to use birth control methods as outlined in the study guidelines.

Who cannot join the trial?

5 criteria

  • Patients who do not have **muscle-invasive bladder cancer** that is eligible for a specific treatment called **Cis** cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are not male or female cannot participate.
  • Patients who are considered part of a **vulnerable population** cannot participate. This means individuals who might be at a higher risk of harm or exploitation.
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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 used around the time of surgery to see if it can improve outcomes for patients with muscle-invasive bladder cancer. It is given in combination with chemotherapy before surgery to help shrink the tumor and make it easier to remove.

  • Neoadjuvant Chemotherapy

    refers to the use of chemotherapy drugs before surgery. The goal of this treatment is to reduce the size of the cancer, making it easier to remove during surgery. In this trial, neoadjuvant chemotherapy is used alongside pembrolizumab to see if this combination can improve the chances of successful treatment for bladder cancer.

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 in treating muscle-invasive bladder cancer that is eligible for cisplatin treatment. 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 protein called PD-1 on immune cells, which can help the immune system to better detect 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.

Investigated diseases

Muscle-invasive bladder cancer – This type of bladder cancer occurs when cancer cells spread 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 invade deeper layers of the bladder and potentially spread to nearby tissues or lymph nodes. The progression may lead to symptoms such as blood in the urine, frequent urination, and pain during urination. If the cancer continues to advance, it can affect other parts of the body. The disease requires careful monitoring to understand its progression and impact on the bladder and surrounding areas.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501970-20-01Protocol codeMK-3475-866Estimated enrolment828 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).