Study on Sacituzumab Govitecan Before Surgery for Treating Non-Urothelial Muscle Invasive Bladder Cancer

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05581589

Provider View

This clinical trial is testing if the drug sacituzumab govitecan, given before surgery, can help treat patients with a specific type of bladder cancer. The drug targets cancer cells and delivers chemotherapy directly to them, potentially making surgery more effective.

Patient Parameters

Program Overview

This phase II study is exploring whether sacituzumab govitecan, administered before surgery, can effectively treat patients with non-urothelial muscle invasive bladder cancer. Sacituzumab govitecan is a targeted therapy that combines a monoclonal antibody with a chemotherapy drug. It attaches to TROP2 receptors on cancer cells, delivering chemotherapy directly to kill them. The aim is to see if this approach can enhance the effectiveness of surgery in treating muscle invasive bladder cancer.

Description

In this study, patients will receive sacituzumab govitecan through an IV over 3 hours on days 1 and 8 of each treatment cycle. This treatment will be repeated every 21 days for a total of 3 cycles, as long as the cancer does not progress and there are no severe side effects. After the last dose, patients will undergo surgery to remove the bladder and nearby lymph nodes within 2 to 6 weeks.

After completing the study treatment, patients will have follow-up visits 1 to 3 months after surgery and then every 3 to 6 months for 2 years to monitor their health and recovery.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to provide informed consent.
  • Have a confirmed diagnosis of muscle invasive bladder cancer, with specific clinical stages.
  • Cancer must not have spread to other parts of the body, confirmed by CT or MRI scans.
  • Must have a review of cancer type by a specialist pathologist.
  • Must be unfit for cisplatin chemotherapy or have refused it after counseling.
  • Eligible for bladder removal surgery and lymph node dissection.
  • Recent tumor tissue sample must be available for research.
  • Men must agree to use contraception during treatment and for 180 days after.
  • Women must not be pregnant or breastfeeding and agree to use contraception if of childbearing potential.
  • Have a performance status score of 0-2, indicating ability to perform daily activities.
  • Meet specific blood count and organ function criteria before starting treatment.
  • Agree to undergo surgery with the intent to cure the cancer.

Exclusion Criteria

  • Have any percentage of neuroendocrine or small cell cancer type.
  • Medically unfit for the study drug, bladder surgery, or tumor removal.
  • Have had recent cancer treatments or radiation therapy.
  • Have advanced or metastatic cancer based on recent imaging.
  • Have an active infection requiring antibiotics.
  • Have active hepatitis B or C infections.
  • Have any condition that could interfere with the study or is not in the patient's best interest.
  • Have a history of psychiatric or substance abuse disorders affecting cooperation.
  • Have other cancers that could interfere with the study, unless inactive or treated with curative intent.
  • Have had major surgery or significant injury recently.
  • Have active inflammatory bowel disease or recent gastrointestinal perforation.
  • Have significant heart disease or recent heart-related events.
  • Unable to comply with the study protocol or allergic to the study drug.
  • Participating in other clinical trials before surgery.
  • Women with a positive pregnancy test or active breastfeeding.
  • Have a history of organ transplant or certain genetic conditions affecting drug metabolism.

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