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Study of Sacituzumab Govitecan and Zimberelimab for Muscle-Invasive Bladder Cancer in Patients Unable to Take Cisplatin or Unwilling to Have Surgery

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 focuses on patients with Muscle-Invasive Bladder Cancer who are unable to receive standard cisplatin treatment or are unwilling to undergo surgery. The study evaluates a combination therapy using two medications: Sacituzumab Govitecan (also known as Trodelvy) and Zimberelimab (also known as AB122). Both medications are given through intravenous infusion, which means they are administered directly into the bloodstream.

The main purpose of this research is to determine how long patients can live without their disease getting worse or requiring additional treatments when using this drug combination. The study will monitor patients to see if the tumor becomes smaller and to evaluate how well they tolerate the treatment. The medications work in different ways - Sacituzumab Govitecan targets cancer cells directly, while Zimberelimab helps the body's immune system fight the cancer.

During the study, participants will receive regular treatments with both medications. Their condition will be monitored through various medical examinations and imaging tests to check how the cancer responds to the treatment. The treatment period may last up to 48 weeks, depending on how well patients respond to the therapy and whether they experience any side effects.

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

    Initial treatment phase

    You will receive two medications through intravenous infusion: zimberelimab and sacituzumab govitecan (Trodelvy)

    The treatment is specifically designed for patients with muscle-invasive bladder cancer who cannot receive cisplatin treatment or have chosen not to undergo surgery

  2. Step 2

    Regular health monitoring

    Your blood counts will be regularly checked to ensure they remain at required levels: hemoglobin at least 9 g/dL, white blood cells at least 1500/mm3, and platelets at least 100,000/μL

    Your liver function will be monitored through regular blood tests

    Your kidney function will be checked by measuring creatinine clearance, which should be at least 30 mL/min

  3. Step 3

    Disease assessment

    Regular examinations will be performed to check your response to treatment

    These assessments will include cystoscopy (examination of the bladder) and CT scans

    The medical team will monitor for any signs of disease progression or improvement

  4. Step 4

    Long-term follow-up

    Your progress will be tracked throughout the study period, which may continue until September 2030

    The medical team will monitor for any new developments in your condition

    Regular assessments will continue to evaluate how well the treatment is working

Who can join the trial?

15 criteria

  • Must be at least 18 years old
  • Must have adequate organ function, including:
    • Sufficient blood counts without need for transfusions
    • Proper liver function
    • Adequate kidney function
    • Normal blood clotting levels
    • For HIV-positive patients:
      • Must be on stable HIV treatment
      • Must have well-controlled HIV with adequate immune cell counts
      • Must have undetectable virus levels for at least 12 weeks
      • Women who can become pregnant and men with partners who can become pregnant must use effective birth control methods
      • Must provide written informed consent to participate in the study
      • Must have an ECOG Performance Status of 0-2 (a measure of daily living abilities)
      • Must be considered unsuitable for bladder removal surgery by medical specialists
      • Must be unable to receive cisplatin treatment due to medical reasons or unwilling to undergo bladder removal surgery
      • Must have muscle-invasive bladder cancer confirmed by tissue examination within 90 days before study entry
      • Cancer must be at stage T2-T4 with specific lymph node status (N0-N1)

Who cannot join the trial?

14 criteria

  • Age under 18 years old
  • History of other cancers in the past 5 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Presence of metastases (cancer spread) to the brain or central nervous system
  • Serious heart conditions including heart failure, unstable angina, or heart attack within the last 6 months
  • Severe kidney or liver disease that affects organ function
  • Active, uncontrolled infections requiring treatment
  • Known allergic reactions to study medications
  • Participation in other clinical trials within the last 30 days
  • Pregnancy or breastfeeding
  • Inability to follow study procedures or attend scheduled visits
  • Major surgery within 4 weeks before starting the study
  • Autoimmune diseases (conditions where the immune system attacks healthy cells) requiring systemic treatment
  • Uncontrolled high blood pressure
  • History of organ transplantation
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Investigated drugs

Sacituzumab Govitecan is a targeted medication known as an antibody-drug conjugate. It works by delivering chemotherapy directly to cancer cells that express a specific protein found in bladder cancer. This medication helps to destroy cancer cells while limiting damage to healthy cells. Zimberelimab is an immunotherapy medication that belongs to a class of drugs called PD-1 inhibitors. It works by helping your immune system recognize and fight cancer cells. This medication removes the "brakes" that cancer cells put on your immune system, allowing it to attack the tumor more effectively. These medications are used together in this trial to treat muscle-invasive bladder cancer in patients who cannot receive cisplatin chemotherapy or do not wish to undergo surgery to remove their bladder.

What is already known about the treatment

  • Sacituzumab Govitecan

    An antibody-drug conjugate medication administered through intravenous infusion, which combines a targeted antibody with a potent chemotherapy drug. It works by specifically targeting the Trop-2 protein found on cancer cells and delivering the chemotherapy component directly to these cells, making it particularly effective in treating various types of cancer including bladder cancer. This targeted therapy represents a modern approach in cancer treatment, belonging to the class of antibody-drug conjugates (ADCs) and is currently being studied in clinical trials for muscle-invasive bladder cancer patients who are not suitable for traditional cisplatin treatment.

  • Zimberelimab

    A monoclonal antibody medication administered through intravenous infusion that functions as an immune checkpoint inhibitor, specifically targeting PD-1 (programmed cell death protein 1). It works by blocking the interaction between PD-1 and its ligands, thereby enhancing T-cell response against cancer cells and boosting the body's natural immune response to fight cancer. This immunotherapy agent is being investigated in clinical trials for various cancer types, including muscle-invasive bladder cancer, and belongs to the broader class of immune checkpoint inhibitors used in modern cancer treatment.

Investigated diseases

Muscle-Invasive Bladder Cancer - A form of bladder cancer where cancer cells have grown through the bladder's muscle wall. The cancer begins in the inner lining of the bladder and progressively spreads into the thick muscle layer of the bladder wall. This condition typically develops from non-muscle-invasive bladder cancer that has progressed deeper into the bladder tissues. The cancer cells can continue to grow and potentially spread to nearby organs and lymph nodes. As the disease progresses, it may cause symptoms such as blood in urine, frequent urination, and pelvic pain.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516943-14-01Protocol codePreSaveEstimated enrolment62 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori

sourced from the EU Clinical Trials Register and site verification

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