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Study Comparing Enfortumab Vedotin and Pembrolizumab with Chemotherapy 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 treatments for muscle-invasive bladder cancer, a type of cancer that affects the bladder muscle. The study will compare two different treatment approaches. One group of participants will receive a combination of two medications: enfortumab vedotin and pembrolizumab (also known by the code name MK-3475). The other group will receive a combination of gemcitabine and cisplatin, which are commonly used chemotherapy drugs. The purpose of the study is to evaluate which treatment is more effective in improving the outcomes for patients with this type of cancer.

Participants in the study will be randomly assigned to one of the two treatment groups. Those in the first group will receive enfortumab vedotin and pembrolizumab, while those in the second group will receive gemcitabine and cisplatin. All treatments will be administered through an intravenous infusion, which means the medication is given directly into a vein. The study will follow participants over a period of time to monitor their health and the progression of their cancer.

The main goal of the study is to compare the event-free survival, which refers to the length of time participants remain free from certain negative events related to their cancer. Additionally, the study will look at other outcomes such as overall survival, which is the length of time participants live after starting the treatment, and the rate of complete response, which means the cancer has disappeared after treatment. Participants' quality of life will also be assessed throughout the study to understand the impact of the treatments on their daily lives.

The research process

The trial runs in 6 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 assigned to one of two groups. Each group will receive a different treatment plan for muscle-invasive bladder cancer.

  2. Step 2

    Treatment group assignment

    If assigned to Arm A, you will receive a combination of enfortumab vedotin and pembrolizumab. These medications are administered through an intravenous infusion, which means they are given directly into your vein.

    If assigned to Arm B, you will receive gemcitabine and cisplatin, also administered through an intravenous infusion.

  3. Step 3

    Treatment administration

    For Arm A, the treatment with enfortumab vedotin and pembrolizumab will be given before and after surgery. The exact schedule and dosage will be explained by your healthcare provider.

    For Arm B, the treatment with gemcitabine and cisplatin will be given before surgery. The exact schedule and dosage will be explained by your healthcare provider.

  4. Step 4

    Surgery

    Both groups will undergo a surgical procedure called radical cystectomy (RC) with pelvic lymph node dissection (PLND). This surgery involves the removal of the bladder and nearby lymph nodes.

  5. Step 5

    Post-surgery treatment

    After surgery, if you are in Arm A, you will continue to receive enfortumab vedotin and pembrolizumab as part of your treatment plan.

    If you are in Arm B, no further chemotherapy is planned after surgery.

  6. Step 6

    Follow-up and monitoring

    Throughout the study, regular follow-up visits will be scheduled to monitor your health and the effectiveness of the treatment. These visits may include physical exams, imaging tests, and laboratory tests.

Who can join the trial?

7 criteria

  • Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) with predominant (50% or more) urothelial histology. This means that a tissue sample from your bladder shows this type of cancer under a microscope.
  • Have clinically non-metastatic bladder cancer, which means the cancer has not spread to other parts of the body. This is determined by imaging tests like a CT scan or MRI of the chest, abdomen, and pelvis.
  • Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND). This means your doctor believes you can undergo surgery to remove the bladder and nearby lymph nodes.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale used to assess how well you can perform daily activities. A score of 0 means you are fully active, and a score of 1 means you have some restrictions but can still do light work.
  • Have adequate organ function, meaning your vital organs like the liver and kidneys are working well enough to handle treatment.
  • Be within the age range of adults and older adults.
  • Both male and female participants are eligible.

Who cannot join the trial?

5 criteria

  • Patients who do not have Muscle Invasive Bladder Cancer cannot participate.
  • Patients who are not within the specified age range 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.
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Investigated drugs

  • Enfortumab Vedotin

    is a type of cancer treatment known as an antibody-drug conjugate. It works by attaching to cancer cells and delivering a powerful drug directly to them, which helps to kill the cancer cells while trying to minimize damage to normal cells. In this trial, it is being used to treat muscle-invasive bladder cancer.

  • Pembrolizumab

    , also known as MK-3475, is an immunotherapy medication. It helps your immune system to recognize and attack cancer cells more effectively. It is used in this trial to help treat muscle-invasive bladder cancer by boosting the body's natural defenses against the cancer.

  • Gemcitabine

    is a chemotherapy drug that works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is used in this trial as part of a treatment plan for muscle-invasive bladder cancer, aiming to shrink the tumor before surgery.

  • Cisplatin

    is another chemotherapy medication that helps to kill cancer cells by damaging their DNA. It is often used in combination with other drugs to treat various types of cancer, including bladder cancer, as part of a strategy to reduce the size of the tumor before surgical removal.

What is already known about the treatment

  • Enfortumab Vedotin

    Enfortumab Vedotin 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. The main therapeutic indication for this medication is to help manage and treat this type of cancer. At the molecular level, Enfortumab Vedotin works by targeting and binding to a specific protein on cancer cells, delivering a toxic substance that helps kill these cells. It is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy.

  • Pembrolizumab

    Pembrolizumab is also administered as an intravenous infusion. It is a well-established medication in the field of oncology and is being evaluated in clinical trials for muscle-invasive bladder cancer. The primary use of Pembrolizumab is to help the immune system recognize and attack cancer cells. It works by blocking a specific protein that prevents the immune system from attacking cancer cells, thereby enhancing the body's immune response against the cancer. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

  • Gemcitabine

    Gemcitabine is given as an intravenous infusion. It is a widely used chemotherapy drug in the treatment of various cancers, including muscle-invasive bladder cancer. The main therapeutic indication is to slow or stop the growth of cancer cells. Gemcitabine works by interfering with the DNA replication process in cancer cells, preventing them from dividing and growing. It is classified as an antimetabolite, a type of chemotherapy.

  • Cisplatin

    Cisplatin is administered through an intravenous infusion. It is a well-known chemotherapy drug used in the treatment of several types of cancer, including muscle-invasive bladder cancer. The primary therapeutic indication is to kill cancer cells and shrink tumors. Cisplatin works by binding to the DNA in cancer cells, causing damage that prevents the cells from dividing and growing. It is classified as a platinum-based chemotherapy agent.

Investigated diseases

Muscle Invasive Bladder Cancer – Muscle Invasive Bladder Cancer is a type of bladder cancer that has spread into the muscle layer of the bladder wall. It typically begins in the cells lining the bladder and progresses deeper into the bladder muscle. As the cancer grows, it can invade surrounding tissues and organs, potentially spreading to other parts of the body. The progression of this disease can lead to symptoms such as blood in the urine, frequent urination, and pain during urination. Over time, the cancer may cause more severe symptoms as it affects other areas. The disease's progression is influenced by various factors, including the cancer's stage and grade.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505615-21-00Protocol codeMK3475-B15Estimated enrolment814 patientsSponsorMerck Sharp & Dohme LLC

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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).