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Adjuvant Datopotamab Deruxtecan with Drug Combination in Patients with High‑Risk Muscle‑Invasive Urothelial Carcinoma

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

The study focuses on High-risk muscle invasive urothelial carcinoma, a form of bladder or upper‑tract cancer that has grown into the muscle layer and carries a high chance of coming back after surgery. The main aim is to determine whether a new treatment approach can keep the disease from returning better than the current standard options.

Participants will receive an intravenous infusion of the experimental combination of Datopotamab deruxtecan and Rilvegostomig, given as an adjuvant therapy, meaning it is administered after the tumor has been surgically removed. The comparison groups will receive one of the existing intravenous medicines such as nivolumab, durvalumab, enfortumab vedotin or pembrolizumab. The study will measure success primarily by disease free survival, which is the length of time a person lives without any sign of the cancer returning, using the standardized assessment method called RECIST 1.1 to evaluate any changes in tumor size.

After surgery, eligible participants are randomly assigned to receive either the new drug combination or one of the standard treatments. The assigned medication is given by IV infusion at regular intervals over several months, and participants attend scheduled clinic visits for physical exams, blood tests, and imaging scans to monitor for any recurrence of cancer or side effects. The study continues until a predefined follow‑up period is completed or until the participant experiences disease recurrence or other discontinuing events.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and randomisation

    After providing informed consent you are assigned a random number that determines which treatment group you will follow in the study.

  2. Step 2

    Baseline assessments

    Before the first dose you undergo a physical examination, blood tests, and imaging scans to document the current status of your cancer.

    These assessments are used later to compare any changes that occur during treatment.

  3. Step 3

    Initiation of study medication

    If you are placed in the experimental arm you receive datopotamab deruxtecan together with rilvegostomig by intravenous infusion.

    If you are placed in a comparator arm you receive one of the following intravenous medicines: nivolumab, durvalumab, enfortumab vedotin combined with pembrolizumab.

    The dose for each medicine is expressed in milligrams or milligrams per kilogram, but the exact amount and schedule are defined by the study protocol and are not specified in the provided information.

  4. Step 4

    Treatment cycles

    The assigned medicines are given repeatedly according to a cycle defined by the study, typically by infusion over a set period of time.

    Each cycle is separated by a resting interval that allows your body to recover before the next infusion.

    The total length of treatment continues until disease recurrence, unacceptable side effects, or the end of the planned treatment period.

  5. Step 5

    Regular monitoring visits

    At scheduled intervals you attend clinic visits for safety checks, blood tests, and evaluation of any side effects.

    Additional imaging scans are performed to monitor the status of the cancer.

    Any background medications such as mycophenolate mofetil (taken by mouth) or infliximab (given by infusion) are continued as instructed.

  6. Step 6

    Disease assessment

    The investigator compares current imaging results with the baseline using the recist 1.1 criteria, which measure changes in tumor size.

    The primary outcome measured is disease‑free survival, defined as the time from randomisation until cancer returns or death from any cause.

  7. Step 7

    Continuation or discontinuation of treatment

    Treatment proceeds as long as the cancer does not recur, side effects remain manageable, and you continue to meet study requirements.

    If disease recurrence, severe toxicity, or other protocol‑specified reasons occur, study medication is stopped.

  8. Step 8

    Post‑treatment follow‑up

    After stopping the study medication you remain under observation for a period defined by the study.

    Follow‑up visits include clinical examinations, laboratory tests, and imaging to record long‑term outcomes such as overall survival and any late side effects.

Who can join the trial?

10 criteria

  • You must be older than 18 years when you sign the Informed Consent Form (ICF).
  • Your cancer must be confirmed by a microscope as muscle invasive urothelial carcinoma (MIUC) that started in the bladder or the upper urinary tract (kidney pelvis or ureter).
  • You must have had an R0 radical resection (complete surgery that removes all visible tumor with clean edges) between 28 and 120 days before randomisation, with negative margins (no cancer at the edges of the removed tissue) and no leftover or spreading (metastatic) cancer.
  • Pathology must show a high‑risk of recurrence based on tumor stage and treatment history:
    • If you did not receive any treatment before surgery, the tumor must be stage T3–T4a with no lymph‑node involvement (N0), or any stage with positive lymph nodes (N+).
    • If you received treatment before surgery (neoadjuvant therapy), the tumor after surgery must be stage ypT2–ypT4a, or any stage with positive lymph nodes (ypN+).
    • At the screening visit, doctors must find no evidence of disease (no cancer visible on tests).
    • You need an ECOG performance status of 0 or 1, meaning you are fully active (0) or able to do light work but not strenuous activity (1), and this level must not have gotten worse in the two weeks before randomisation.
    • You must have a life expectancy of more than 12 weeks at the time of screening.
    • A saved piece of the tumor from your surgery (archival surgical tumour sample) must be available for central laboratory testing before randomisation.
    • Your blood tests and organ checks must show adequate organ and bone marrow function (normal blood counts and organ health) within 28 days before randomisation.

Who cannot join the trial?

20 criteria

  • Cannot have a tumor that is mainly or entirely a high‑grade neuroendocrine carcinoma, a rare and aggressive type of cancer.
  • Cannot have any active or uncontrolled infection (including tuberculosis) that still needs medication at the time of randomisation.
  • Cannot have a history of non‑infectious interstitial lung disease (ILD) or pneumonitis (lung inflammation), especially if it required steroids, is still present, or cannot be ruled out by a scan.
  • Cannot have severely reduced lung function that makes breathing very difficult.
  • Cannot have a resting heart‑rate‑corrected QT interval (QTcF) longer than 470 milliseconds on an ECG, which can indicate a risk of abnormal heart rhythms.
  • Cannot have uncontrolled or serious heart problems.
  • Cannot have an autoimmune or inflammatory disease that needed systemic (whole‑body) treatment in the past five years.
  • Cannot have previously received any therapy that targets TROP2, other antibody‑drug conjugates (ADCs) with deruxtecan, anti‑cancer vaccines, anti‑TIGIT drugs, or similar immune‑targeting cancer treatments.
  • Cannot have taken medicines that suppress the immune system within 14 days before being assigned to a treatment group.
  • Cannot have a known severe allergic (hypersensitivity) reaction to any of the study drugs.
  • Cannot be ineligible to receive at least one standard‑of‑care treatment according to local rules.
  • Cannot have had a partial removal of the bladder (partial cystectomy) or a partial removal of a kidney (partial nephrectomy) for bladder or kidney cancer.
  • Cannot be currently pregnant, breastfeeding, or planning to become pregnant.
  • Cannot have received any additional chemotherapy or radiation therapy after surgery for urothelial cancer.
  • Cannot have severe or uncontrolled overall illnesses, a history of organ transplant or stem‑cell transplant, serious mental health or social problems, or ongoing substance abuse.
  • Cannot have a history of serious eye disease affecting the cornea.
  • Cannot have another primary cancer, unless it was treated with curative intent, has no active disease, and was diagnosed more than two years ago with low risk of coming back.
  • Cannot have ongoing side effects from previous cancer treatment that are worse than mild (grade 1), except for hair loss; stable moderate side effects (grade 2) are allowed only if unchanged for at least three months and well‑managed.
  • Cannot have an active or uncontrolled hepatitis B or hepatitis C infection.
  • Cannot have HIV infection that is not well‑controlled with medication.
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Investigated drugs

  • Rilvegostomig

    is an investigational drug given by IV infusion. In this trial it is combined with another investigational therapy to see if the pair can better prevent cancer from coming back after surgery.

  • Datopotamab deruxtecan

    is a new targeted therapy that is delivered through an IV drip. It works by attaching to a specific protein on cancer cells and delivering a chemotherapy payload directly to those cells, aiming to kill the tumor while sparing normal tissue.

  • Enfortumab vedotin

    is an approved antibody‑drug conjugate that is given intravenously. It targets a protein found on bladder cancer cells and carries a chemotherapy drug into the cancer, helping to destroy the tumor. In this study it is used as part of the standard‑of‑care comparison.

  • Durvalumab

    is an immunotherapy drug administered by IV infusion. It helps the body’s immune system recognize and attack cancer cells by blocking a protein called PD‑L1. It serves as one of the standard‑of‑care options in the comparison arm.

  • Nivolumab

    is another IV immunotherapy that works by releasing the brakes on the immune system, allowing it to fight cancer more effectively. It is also used as a standard‑of‑care option in the control arm of the trial.

  • Pembrolizumab

    is an IV‑administered immune checkpoint inhibitor that blocks the PD‑1 pathway, helping the immune system to detect and kill cancer cells. In this study it is combined with other drugs as part of the standard‑of‑care regimen.

What is already known about the treatment

  • Rilvegostomig

    This medication is given as an intravenous infusion solution. It is currently being studied in clinical trials and is not yet approved for general use. It is being tested for high‑risk muscle invasive urothelial carcinoma as part of a combination therapy. Rilvegostomig works by attaching to a protein on cancer cells and delivering a toxic payload that kills the cells, and it belongs to the class of antibody‑drug conjugates.

  • Datopotamab deruxtecan

    Datopotamab deruxtecan is administered by intravenous infusion of a solution. It is an investigational drug still in clinical development and has not received full regulatory approval. The drug is being evaluated for urothelial carcinoma after surgery. It targets the TROP2 protein on tumor cells, releases a chemotherapy agent inside the cells, and is classified as an antibody‑drug conjugate.

  • Enfortumab vedotin

    Enfortumab vedotin is given as an intravenous infusion. It has received FDA approval for treating urothelial carcinoma that has progressed after prior therapy. The drug binds to the Nectin‑4 protein on cancer cells and releases a cell‑killing agent called MMAE. It is classified as an antibody‑drug conjugate.

  • Durvalumab

    Durvalumab is administered by intravenous infusion. It is an approved therapy for bladder cancer and several other tumor types. The medication blocks the PD‑L1 protein, helping the immune system recognize and attack cancer cells. It belongs to the class of PD‑L1 immune checkpoint inhibitors.

  • Nivolumab

    Nivolumab is given as an intravenous infusion. It is approved for many cancers, including bladder cancer. The drug blocks the PD‑1 receptor on immune cells, allowing them to better target tumors. It is classified as a PD‑1 immune checkpoint inhibitor.

  • Pembrolizumab

    Pembrolizumab is administered intravenously. It has regulatory approval for a wide range of cancers such as bladder cancer. It works by inhibiting the PD‑1 pathway, which enhances the body’s immune response against tumor cells. It is a PD‑1 immune checkpoint inhibitor.

Investigated diseases

High-risk muscle‑invasive urothelial carcinoma of the bladder or upper urinary tract - This cancer begins in the lining of the bladder, renal pelvis, or ureter and has grown into the muscle layer of the urinary tract wall. Being high‑risk means the tumor cells have a greater tendency to spread beyond the original site. The disease can recur locally within the urinary tract or appear in distant areas of the body. As it progresses, cancer may extend into surrounding tissues and nearby lymph nodes. Ongoing observation after surgery aims to detect any new growths as early as possible.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-525030-57-00Protocol codeD763TC00001Estimated enrolment915 patientsSponsorAstraZeneca AB

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