Study on Sacituzumab Tirumotecan Treatment Compared to Standard Care for Recurrent Ovarian Cancer
Sponsor: Merck Sharp & Dohme LLC
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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Nebraska Methodist Hospital ( Site 0053) | 68114 | Omaha | Nebraska |
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