Study on Sacituzumab Tirumotecan Treatment Compared to Standard Care for Recurrent Ovarian Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT06824467

This clinical trial is testing a new treatment, sacituzumab tirumotecan, with or without bevacizumab, to see if it is safe and helps patients with platinum-sensitive recurrent ovarian cancer live longer without the disease worsening, compared to standard treatments.

Patient Parameters

Program Overview

The main aim of this study is to find out if the new treatment, sacituzumab tirumotecan, used with or without bevacizumab, is safe and well-tolerated by patients. Researchers also want to see if this treatment helps patients with platinum-sensitive recurrent ovarian cancer live longer without their cancer getting worse, compared to those receiving standard care.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Completed at least 4 cycles of platinum-based chemotherapy initially and 6 cycles of carboplatin-based chemotherapy in the second round of treatment.
  • Cancer is sensitive to platinum-based treatments.
  • Provided a sample of tumor tissue that hasn't been treated with radiation.
  • If HIV-positive, must have well-controlled HIV with medication.
  • If hepatitis B positive, must have been on antiviral treatment for at least 4 weeks and have no detectable virus before starting the study.
  • If previously infected with hepatitis C, must have no detectable virus at screening.
  • Must be in good general health with an ECOG performance status of 0 or 1.

Exclusion Criteria

  • Have types of ovarian cancer that are not epithelial, such as germ cell tumors or sex cord-stromal tumors.
  • Have ovarian cancer that does not respond to platinum-based treatments.
  • Have severe eye conditions like dry eye syndrome or corneal disease.
  • Have active inflammatory bowel disease or a history of it.
  • Have serious heart or blood vessel diseases.
  • Have lung diseases that required steroid treatment.
  • Have HIV with a history of certain related diseases.
  • Have had more than 2 previous treatments for ovarian cancer.
  • Have had cancer treatments or radiation recently.
  • Have another active cancer that needed treatment in the last 3 years.
  • Have cancer that has spread to the brain or spinal cord.
  • Have an active infection needing treatment.

Locations

FACILITYZIPCITYSTATE
Nebraska Methodist Hospital ( Site 0053)68114OmahaNebraska

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