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Study of Disitamab Vedotin and Pembrolizumab for Patients with Untreated Advanced Urothelial Cancer Expressing HER2

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 a type of cancer called urothelial carcinoma, which affects the lining of the bladder and other parts of the urinary system. The study aims to compare the effectiveness of a new treatment combination against standard chemotherapy. The new treatment involves two medications: Disitamab Vedotin and Pembrolizumab. Disitamab Vedotin is a type of medication that targets cancer cells, while Pembrolizumab is an immunotherapy drug that helps the immune system fight cancer. The chemotherapy options being compared include Cisplatin, Carboplatin, and Gemcitabine, which are commonly used to treat various cancers.

The purpose of this study is to determine if the combination of Disitamab Vedotin and Pembrolizumab is more effective than the standard chemotherapy treatments for patients with advanced urothelial carcinoma that shows a specific protein called HER2. HER2 is a protein that can affect the growth of cancer cells. The study will involve patients who have not received prior treatment for their advanced cancer. Participants will be randomly assigned to receive either the new treatment combination or one of the standard chemotherapy options. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments.

Throughout the study, participants will receive their assigned treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the participants' health and response to the treatment over a period of time to gather information on the effectiveness and safety of the treatments. The goal is to find out which treatment option provides better outcomes for patients with this type of cancer. This research could potentially lead to improved treatment options for people with advanced urothelial carcinoma.

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, eligibility is confirmed based on specific criteria, including age, laboratory values, and medical history.

    Consent is documented, and the ability to comply with trial procedures is assessed.

  2. Step 2

    Initial assessment

    A comprehensive medical evaluation is conducted, including a review of medical history and current health status.

    Baseline laboratory tests and imaging studies are performed to assess the condition and eligibility.

  3. Step 3

    Randomization

    Participants are randomly assigned to one of two groups: one receiving disitamab vedotin with pembrolizumab, and the other receiving chemotherapy.

  4. Step 4

    Treatment administration

    For the disitamab vedotin and pembrolizumab group, disitamab vedotin is administered via intravenous infusion, and pembrolizumab is given as a concentrate for solution for infusion.

    For the chemotherapy group, medications such as cisplatin, carboplatin, and gemcitabine are administered through intravenous infusion.

    The frequency and dosage of each medication are determined by the study protocol and the participant's health status.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects.

    Follow-up visits include physical examinations, laboratory tests, and imaging studies to evaluate the progress of the condition.

  6. Step 6

    Completion of treatment

    Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response and any long-term effects.

    Participants may be asked to continue follow-up visits to monitor their health status.

Who can join the trial?

26 criteria

  • Must be 18 years or older, or considered an adult by local rules.
  • Must have certain laboratory test results within specific ranges, such as:
    • Hemoglobin (Hb) of at least 9 grams per deciliter without needing a blood transfusion.
    • Absolute Neutrophil Count (ANC) of at least 1.5 x 109 per liter.
    • Platelet count of at least 100 x 109 per liter.
    • ALT and AST (liver enzymes) within 2.5 times the normal limit if no liver spread, or 5 times if there is liver spread.
    • Serum total bilirubin within 1.5 times the normal limit, or direct bilirubin within normal limits if total bilirubin is higher.
    • Creatinine clearance (CrCl) of at least 30 milliliters per minute, calculated using a specific formula.
    • INR or PT and aPTT (blood clotting tests) within 1.5 times the normal limit. If on blood thinners, these should be within the therapeutic range.
    • If able to have children, must:
      • Have a negative pregnancy test before starting the study.
      • Agree not to become pregnant during the study and for a certain period after the last dose of study drugs.
      • Agree not to breastfeed or donate eggs during the study and for a certain period after the last dose of study drugs.
      • If sexually active, use at least two methods of birth control, one being highly effective, during the study and for a certain period after the last dose of study drugs.
      • If able to father children, must:
        • Agree not to donate sperm during the study and for a certain period after the last dose of study drugs.
        • If sexually active with someone who can become pregnant, use at least two methods of birth control, one being highly effective, during the study and for a certain period after the last dose of study drugs.
        • If sexually active with someone who is pregnant or breastfeeding, consistently use a condom during the study and for a certain period after the last dose of study drugs.
        • Must provide written consent to participate in the study.
        • Must be willing and able to follow the study procedures and schedule.
        • Must have a specific type of cancer called locally advanced or metastatic urothelial carcinoma, confirmed by a lab test, and it must be the main type of cancer cell.
        • Must have cancer that can be measured by the study doctor using specific guidelines. If radiation therapy was received before, the cancer must be measurable outside the treated area or have clearly grown since the treatment.
        • Must not have received previous treatment for advanced or spread urothelial cancer, except if it was given before surgery or after surgery and the cancer returned more than 12 months after the last treatment.
        • Must be eligible to receive certain chemotherapy drugs, as determined by the study doctor. If not eligible for one drug, another will be given.
        • Must be willing and able to provide a sample of the cancer tissue for testing before starting the study treatment. If a previous sample is not available, a new biopsy must be done.
        • The cancer must show a certain level of a protein called HER2 as determined by a lab test.
        • Must have a performance status score of 0, 1, or 2, which measures the ability to perform daily activities. If the score is 2, additional health criteria must be met.
        • Must have adequate heart function, including:
          • Left Ventricular Ejection Fraction (LVEF) of at least 50%.
          • Corrected QT interval (QTcF) less than 470 milliseconds, which is a measure of heart rhythm.

Who cannot join the trial?

10 criteria

  • Patients who have had another type of cancer in the past, unless it was a type that is not expected to come back.
  • Patients who have serious heart problems, such as heart failure or a recent heart attack.
  • Patients who have an active infection that needs treatment with antibiotics.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to the study drugs or similar drugs.
  • Patients who have received certain treatments for cancer in the past, like chemotherapy or radiation, that might interfere with the study.
  • Patients who have a condition that affects their immune system, like HIV or autoimmune diseases.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse that could interfere with the study.
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Investigated drugs

  • Disitamab Vedotin

    is a medication used in this trial to treat advanced urothelial carcinoma, a type of bladder cancer. It is designed to target and attach to cancer cells that express a protein called HER2, helping to deliver a cancer-fighting agent directly to the tumor cells.

  • Pembrolizumab

    is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. It is used in combination with disitamab vedotin in this trial to enhance the treatment's effectiveness against advanced urothelial carcinoma.

  • Chemotherapy

    refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used as a comparison treatment to evaluate the effectiveness of the combination of disitamab vedotin and pembrolizumab.

What is already known about the treatment

  • Disitamab Vedotin

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating urothelial carcinoma, particularly in cases where the cancer expresses HER2. It is an antibody-drug conjugate, which means it combines an antibody with a drug to specifically target and kill cancer cells. Disitamab Vedotin works by binding to the HER2 protein on cancer cells, delivering a toxic agent directly to the cells, thereby inhibiting their growth. It is classified as an antineoplastic agent.

  • Pembrolizumab

    This medication is also administered intravenously and is widely used in the treatment of various cancers, including urothelial carcinoma. It is an immune checkpoint inhibitor that works by blocking the PD-1 pathway, which cancer cells use to evade the immune system. By inhibiting this pathway, Pembrolizumab helps the immune system recognize and attack cancer cells more effectively. It is classified as an immunotherapy drug.

Investigated diseases

Urothelial Carcinoma – Urothelial carcinoma 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 and can also occur in the ureters and renal pelvis. The disease often starts in the innermost layer of the bladder and can grow into deeper layers over time. As it progresses, it may spread to nearby tissues and organs, and in advanced stages, it can metastasize to distant parts of the body. Symptoms may 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 invasive.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501105-12-00Protocol codeSGNDV-001/KN-D74Estimated enrolment400 patientsSponsorSeagen Inc.

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