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Study of Enfortumab Vedotin and Pembrolizumab for Patients with Advanced or Metastatic Urothelial Cancer

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 urothelial cancer, a type of cancer that affects the bladder and other parts of the urinary system. The study is comparing two different treatment approaches. One group of participants will receive a combination of two medications: enfortumab vedotin and pembrolizumab. Pembrolizumab is also known by its code name, MK-3475. The other group will receive standard chemotherapy, which may include medications like gemcitabine, cisplatin, or carboplatin. These treatments are given as solutions through an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to compare the effectiveness of the combination treatment with the standard chemotherapy in people who have not received prior treatment for their advanced or metastatic urothelial cancer. Participants will be randomly assigned to one of the two treatment groups. The study will monitor the participants over a period of time to see how well the cancer responds to the treatments and to assess overall survival rates.

Throughout the study, participants will receive regular medical check-ups and monitoring to ensure their safety and to track the progress of their treatment. The study aims to provide valuable information on whether the combination of enfortumab vedotin and pembrolizumab offers better outcomes compared to the standard chemotherapy options for patients with this type of 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 study

    Upon joining the study, the patient will be randomly assigned to one of two groups: the experimental group or the control group.

    The experimental group will receive a combination of enfortumab vedotin and pembrolizumab, while the control group will receive chemotherapy with either gemcitabine and cisplatin or carboplatin.

  2. Step 2

    Treatment administration

    All medications will be administered as a solution for infusion, which means they will be given through a vein (intravenously).

    The specific dosage and frequency of administration will depend on the group to which the patient is assigned.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's health and response to treatment will be closely monitored.

    Regular assessments will be conducted to evaluate the progression of the disease and the patient's overall health status.

  4. Step 4

    Completion of treatment

    The duration of the treatment will vary depending on the patient's response and the specific protocol of the study.

    After completing the treatment, follow-up assessments will be conducted to monitor the patient's health and any long-term effects of the treatment.

Who can join the trial?

13 criteria

  • Must have a type of cancer called urothelial carcinoma, which affects areas like the bladder, kidney area, or tubes that carry urine.
  • Must be 18 years or older.
  • Must have a measurable disease, meaning the cancer can be measured by doctors using specific guidelines.
  • Must have a performance status score of 0, 1, or 2, which is a way to measure how well you can perform daily activities. If the score is 2, additional health criteria must be met.
  • Must provide a sample of the tumor for testing before starting the study. If an old sample is not available, a new one may be needed.
  • Must have adequate blood and organ function based on specific lab tests.
  • Women who can have children must agree not to become pregnant during the study and for 6 months after. They must also have a negative pregnancy test before starting the study and use effective birth control.
  • Women must agree not to breastfeed or donate eggs during the study and for 6 months after.
  • Men who can father children must agree not to donate sperm during the study and for 6 months after. They must also use effective birth control.
  • Men with pregnant or breastfeeding partners must use specific precautions to prevent exposure to their partner during the study and for 6 months after.
  • Must not have received previous treatment for advanced urothelial carcinoma, except in certain cases where treatment was given over 12 months ago.
  • Must be eligible to receive certain chemotherapy drugs, as determined by the doctor.
  • Must provide written consent to participate in the study.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer other than urothelial cancer cannot participate. Urothelial cancer is a type of cancer that affects the lining of the urinary system.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, may not be eligible to participate.
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Investigated drugs

  • Enfortumab Vedotin

    is a medication used in the trial to treat urothelial cancer. It is an antibody-drug conjugate, which means it combines an antibody with a drug to target and kill cancer cells more effectively. In this study, it is used in combination with another medication to see if it improves outcomes for patients with advanced cancer.

  • Pembrolizumab

    is an immunotherapy drug that helps the body's immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to recognize and attack them. In this trial, it is used alongside enfortumab vedotin to evaluate its effectiveness in treating advanced urothelial cancer.

  • Gemcitabine

    is a chemotherapy drug used to treat various types of cancer, including urothelial cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this study, it is part of the control arm to compare its effectiveness against the experimental treatment.

  • Cisplatin

    is another chemotherapy medication used in the trial. It works by damaging the DNA in cancer cells, which stops them from multiplying. It is often used in combination with other chemotherapy drugs to treat advanced cancers.

  • Carboplatin

    is similar to cisplatin and is used as an alternative chemotherapy option in the trial. It also targets the DNA of cancer cells to prevent their growth. The study compares its effectiveness with the experimental treatment to determine the best approach for treating advanced urothelial cancer.

What is already known about the treatment

  • Enfortumab Vedotin

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating urothelial cancer. It is an antibody-drug conjugate that targets cancer cells by binding to a specific protein on their surface, delivering a toxic agent directly to the cancer cells to destroy them. Enfortumab Vedotin is classified as an antineoplastic agent and is being evaluated for its potential to improve progression-free survival and overall survival in patients with advanced urothelial cancer.

  • Pembrolizumab

    Administered through intravenous infusion, Pembrolizumab is an established medication in the treatment of various cancers, including urothelial cancer. It works by blocking a protein called PD-1 on immune cells, enhancing the body's immune response against cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor and is being tested in combination with Enfortumab Vedotin to assess its effectiveness in improving survival outcomes in patients with advanced urothelial cancer.

  • Gemcitabine

    This medication is given intravenously and is widely used in chemotherapy for various cancers, including urothelial cancer. It works by interfering with the DNA synthesis of cancer cells, preventing them from growing and dividing. Gemcitabine is classified as an antimetabolite and is being used as a control treatment in clinical trials to compare its effectiveness with newer therapies.

  • Cisplatin

    Administered intravenously, Cisplatin is a well-known chemotherapy drug used to treat several types of cancer, including urothelial cancer. It works by forming cross-links in DNA, which ultimately leads to cell death. Cisplatin is classified as a platinum-based chemotherapy agent and is part of the standard treatment regimen being compared in clinical trials.

  • Carboplatin

    This medication is given intravenously and is used in chemotherapy for various cancers, including urothelial cancer. Similar to Cisplatin, it works by binding to DNA and causing cell death. Carboplatin is also a platinum-based chemotherapy agent and is being used as a control treatment in clinical trials to evaluate its effectiveness against newer treatment combinations.

Investigated diseases

Urothelial Cancer – Urothelial cancer is a type of cancer that begins in the urothelial cells lining the bladder and other parts of the urinary tract. It is the most common form of bladder cancer. The disease often starts in the bladder's inner lining and can progress to invade deeper layers of the bladder wall. As it advances, it may spread to nearby tissues and organs, including 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 superficial while others become more invasive.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503421-19-00Protocol codeC5701003Estimated enrolment1 422 patientsSponsorSeagen Inc.

sourced from the EU Clinical Trials Register and site verification

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