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Study of Pembrolizumab and Enfortumab Vedotin with Surgery vs. Surgery Alone for Patients with Muscle-Invasive Bladder Cancer Who Cannot or Choose Not to Use Cisplatin

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 muscle-invasive bladder cancer, a type of cancer that affects the bladder muscle. The study involves the use of two medications: pembrolizumab, also known by its code name MK-3475, and enfortumab vedotin. Pembrolizumab is a medication that helps the immune system fight cancer cells, while enfortumab vedotin is a drug that targets and kills cancer cells directly. The purpose of the study is to compare the effectiveness of different treatment combinations in improving the time patients remain free from cancer-related events.

Participants in the study will be divided into different groups. One group will receive pembrolizumab along with a surgical procedure called a cystectomy, which involves removing the bladder. Another group will receive both pembrolizumab and enfortumab vedotin, along with the cystectomy. There is also a group that will undergo the cystectomy alone. The study will observe how these treatments affect the participants over time, focusing on how long they remain free from cancer-related events and their overall survival.

The study aims to provide valuable information on the potential benefits of combining these medications with surgery for patients who cannot or choose not to receive a common chemotherapy drug called cisplatin. By comparing these different approaches, researchers hope to find more effective treatment options for individuals with muscle-invasive bladder cancer. Participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein.

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 is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A diagnosis of muscle-invasive bladder cancer is confirmed through imaging and pathology tests.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to one of three groups: cystectomy alone, cystectomy with pembrolizumab, or cystectomy with both pembrolizumab and enfortumab vedotin.

  3. Step 3

    Pre-surgery treatment

    For those receiving pembrolizumab, the medication is administered as an intravenous infusion. The dosage is 25 mg/mL, given every three weeks.

    Participants in the combination group also receive enfortumab vedotin as an intravenous infusion, with the dosage and frequency determined by the study protocol.

  4. Step 4

    Surgery

    A radical cystectomy, which involves the removal of the bladder and surrounding tissues, is performed. This may include pelvic lymph node dissection and prostatectomy if applicable.

  5. Step 5

    Post-surgery treatment

    Participants in the pembrolizumab and combination groups continue to receive their respective treatments post-surgery, following the same dosage and frequency as pre-surgery.

  6. Step 6

    Follow-up

    Regular follow-up visits are scheduled to monitor health status and assess the effectiveness of the treatment. This includes imaging tests and laboratory assessments.

  7. Step 7

    Study completion

    The study is expected to conclude by December 2027. Participants will be informed of the study results and any further recommendations for their care.

Who can join the trial?

9 criteria

  • The patient must have a confirmed diagnosis of **urothelial carcinoma** or **muscle-invasive bladder cancer**. This means the cancer is in the bladder muscle and has a specific type of cell called urothelial cells.
  • The cancer must not have spread to other parts of the body, as shown by imaging tests.
  • The patient must be eligible for a surgery called **radical cystectomy** (removal of the bladder) and **pelvic lymph node dissection** (removal of lymph nodes in the pelvic area) and agree to undergo this surgery.
  • The patient must have had a procedure called **transurethral resection** of a bladder tumor, which helps to check the type of cancer cells and a protein called **PD-L1**.
  • The patient must have an **ECOG performance status** of 0, 1, or 2. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • The patient must have organs that are working well enough to participate in the study.
  • Male participants must agree to use birth control and not donate sperm during the study and for at least 180 days after the last dose of a drug called **enfortumab vedotin**. If they are only receiving another drug called **pembrolizumab** or having surgery, there are no birth control requirements.
  • Female participants must not be pregnant or breastfeeding. They must either not be able to have children or agree to use a highly effective birth control method or not have heterosexual intercourse during the study and for at least 120 days after the last dose of pembrolizumab and at least 180 days after the last dose of enfortumab vedotin, whichever is longer. They must also agree not to donate eggs during this time.
  • Women who can have children must have a negative pregnancy test within 24 hours before starting the study treatment.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer than Muscle Invasive Bladder Cancer cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet the specific health requirements set by the study cannot participate. These requirements are not detailed here.
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Investigated drugs

  • Pembrolizumab

    is a medication used in this trial to help the body's immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells. This helps the immune system to better recognize and destroy cancer cells.

  • Enfortumab Vedotin

    is another medication used in the trial. It is designed to target and kill cancer cells directly. It attaches to a specific protein found on the surface of cancer cells and delivers a toxic substance that can destroy these cells. This helps to reduce the size of the tumor and prevent the cancer from spreading.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating muscle-invasive bladder cancer. It is an approved immunotherapy drug that works by blocking a specific protein on immune cells, allowing them to better attack cancer cells. Pembrolizumab is classified as a monoclonal antibody and is used primarily for various types of cancer, including bladder cancer.

  • Enfortumab Vedotin

    This medication is also administered intravenously and is being evaluated in combination with pembrolizumab for muscle-invasive bladder cancer. It is an investigational drug that targets a protein found on cancer cells, delivering a toxic agent to kill these cells. Enfortumab Vedotin is classified as an antibody-drug conjugate and is specifically designed to treat certain types of cancer, including bladder cancer.

Investigated diseases

Muscle Invasive Bladder Cancer – This is a type of bladder cancer where the cancer cells have spread into the muscle layer of the bladder wall. It often begins in the cells lining the bladder and can progress to invade deeper layers, including the muscle. As the disease advances, it may spread to nearby tissues and organs, potentially affecting the lymph nodes and other parts of the body. Symptoms can include blood in the urine, frequent urination, and pain during urination. The progression of the disease can vary, with some cases remaining localized while others may become more aggressive. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504932-16-00Protocol codeMK-3475-905Estimated enrolment663 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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