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Study of datopotamab deruxtecan with platinum-based therapy compared to gemcitabine with platinum-based therapy in patients with advanced urothelial cancer after prior treatment

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 study focuses on treating patients with Locally Advanced or Metastatic Urothelial Carcinoma, a type of cancer that affects the urinary system, including the bladder, kidney pelvis, ureter, or urethra, and has spread to nearby tissues or other parts of the body. The study will test a new medication called datopotamab deruxtecan (also known as Dato-DXd) in combination with either carboplatin or cisplatin, comparing it to a combination of gemcitabine with carboplatin or cisplatin.

The purpose of this research is to evaluate how well datopotamab deruxtecan works when combined with platinum-based therapy (carboplatin or cisplatin) compared to the standard treatment of gemcitabine with platinum-based therapy. The study is designed for patients whose cancer has progressed during or after previous treatment with enfortumab vedotin and pembrolizumab.

During the study, participants will receive their assigned treatment through intravenous infusion. The medications will be given in cycles, with treatment continuing for up to 120 weeks for datopotamab deruxtecan and up to 5 weeks for the other medications. Throughout the study, doctors will monitor the participants' response to treatment through various medical examinations and imaging tests.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical assessment

    You will undergo evaluation to confirm locally advanced or metastatic urothelial carcinoma (cancer in the urinary system).

    Your doctor will review your medical history and perform necessary tests to ensure you meet the study requirements.

    A tissue sample from your tumor will be required for testing.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive one of two treatment combinations:

    Option 1: Datopotamab deruxtecan plus either carboplatin or cisplatin

    Option 2: Gemcitabine plus either carboplatin or cisplatin

    All medications will be given through intravenous infusion (delivered directly into your vein)

  3. Step 3

    Treatment period

    You will receive regular treatment sessions according to your assigned medication combination

    Your doctor will monitor your response to treatment through regular imaging scans

    Blood tests will be performed to check your body's response to the treatment

    Your overall health status will be regularly assessed

  4. Step 4

    Monitoring and assessment

    Regular physical examinations will be conducted

    Imaging scans will track any changes in your cancer

    Side effects will be monitored and documented

    Quality of life assessments will be performed using questionnaires

  5. Step 5

    Follow-up period

    After completing treatment, you will continue to have regular check-ups

    Your health status will be monitored to track long-term outcomes

    The study will continue until April 2030

Who can join the trial?

8 criteria

  • Must be 18 years or older when signing the consent form
  • Must have confirmed urothelial carcinoma (cancer in the urinary system) that is either: - Advanced and cannot be surgically removed, or - Has spread to other parts of the body (metastatic)
  • Must be able to provide a tissue sample from previous tests or agree to a new biopsy
  • Must be suitable to receive treatment with cisplatin or carboplatin (types of chemotherapy medications)
  • Must have had disease progression during or after previous treatment with enfortumab vedotin and pembrolizumab (cancer medications). Patients who stopped these treatments due to side effects are eligible if their disease has progressed
  • Must have cancer that can be measured on CT or MRI scans (imaging tests)
  • Must have good physical function, with an ECOG performance status of 0 or 1 (able to perform daily activities with minimal assistance)
  • Must have acceptable levels in laboratory tests showing: - Good bone marrow function - Good kidney function - Good liver function - Normal blood clotting

Who cannot join the trial?

11 criteria

  • History of active brain metastases (cancer that has spread to the brain) within the last 3 months
  • Known allergic reactions to platinum-based drugs or similar medications used in the study
  • Significant heart problems including heart failure or uncontrolled high blood pressure
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • Other types of cancer within the past 3 years (except for successfully treated skin cancer or early-stage cancer)
  • Pregnant or breastfeeding women
  • Severe kidney or liver problems
  • Previous treatment with similar cancer medications within the past 4 weeks
  • Any medical condition that could interfere with the study treatment or affect patient safety
  • Unable to swallow medications or have conditions that could affect drug absorption
  • Participation in another clinical trial within the past 4 weeks
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Investigated drugs

  • Datopotamab Deruxtecan

    (also known as Dato-DXd) is an antibody-drug conjugate medication that targets specific cancer cells in patients with urothelial carcinoma (bladder cancer and cancers of the urinary system). It works by delivering cancer-fighting medicine directly to tumor cells.

  • Carboplatin

    is a chemotherapy medication used to treat various types of cancer. It works by interfering with cancer cell DNA, which helps stop cancer cells from growing and dividing.

  • Cisplatin

    is a chemotherapy medication similar to carboplatin. It also works by damaging cancer cell DNA to stop tumor growth and spread.

  • Gemcitabine

    is a chemotherapy medication that works by preventing cancer cells from making and repairing DNA, which stops them from multiplying.

  • Enfortumab Vedotin

    is an antibody-drug conjugate that targets specific proteins found on cancer cells to deliver cancer-fighting medicine directly to the tumors.

  • Pembrolizumab

    is an immunotherapy medication that helps the body's immune system recognize and fight cancer cells more effectively.

What is already known about the treatment

  • Datopotamab Deruxtecan (Dato-DXd)

    An investigational antibody-drug conjugate administered intravenously that is being studied for the treatment of locally advanced or metastatic urothelial carcinoma. This medication combines a monoclonal antibody with a potent topoisomerase inhibitor, targeting specific cancer cells while delivering the chemotherapy agent directly to the tumor. It is currently being evaluated in clinical trials in combination with platinum-based therapy for patients who have progressed after previous treatment with enfortumab vedotin and pembrolizumab.

  • Carboplatin

    A platinum-based chemotherapy drug administered intravenously that works by interfering with DNA replication in cancer cells. It is commonly used in the treatment of various cancers, including urothelial carcinoma, and is known for having a more manageable side effect profile compared to other platinum compounds. The medication acts by forming cross-links in DNA strands, preventing cancer cells from dividing and multiplying.

  • Cisplatin

    A widely-used platinum-containing chemotherapy medication given through intravenous infusion that has been a cornerstone of cancer treatment for decades. It works by damaging the DNA of cancer cells, preventing them from dividing and ultimately leading to their death. In urothelial carcinoma treatment, it is often used in combination with other medications and is known for its effectiveness, though it requires careful monitoring due to potential side effects.

  • Gemcitabine

    A chemotherapy medication administered intravenously that belongs to a class of drugs called antimetabolites. It works by interfering with the cancer cells' ability to make DNA, preventing them from growing and dividing. The drug is commonly used in combination with platinum-based therapies for treating various types of cancer, including urothelial carcinoma, and has demonstrated effectiveness in both first-line and subsequent treatment settings.

Investigated diseases

Urothelial Carcinoma - A type of cancer that begins in the cells lining the urinary system, most commonly in the bladder. The disease can develop in the renal pelvis, ureter, bladder, and urethra, affecting the transitional epithelial cells that make up the inner lining of these organs. When described as locally advanced, the cancer has grown into deeper layers of the bladder wall or nearby tissues. In metastatic form, the cancer has spread beyond its original location to other parts of the body, such as lymph nodes, bones, liver, or lungs. The condition typically develops gradually, with the abnormal cells multiplying and forming tumors in the urinary system.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-516906-47-00Protocol codeDS1062-328Estimated enrolment649 patientsSponsorDaiichi Sankyo Inc.

sourced from the EU Clinical Trials Register and site verification

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