Study of Trastuzumab Deruxtecan with Bevacizumab vs. Bevacizumab Alone for First-line Maintenance in HER2-Expressing Ovarian Cancer
Sponsor: Daiichi Sankyo
ClinicalTrials ID:NCT06819007
This clinical trial is testing whether a combination of two drugs, Trastuzumab Deruxtecan and Bevacizumab, is more effective and safe compared to Bevacizumab alone for maintaining treatment in patients with advanced ovarian cancer that shows HER2 protein expression.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate if using Trastuzumab Deruxtecan together with Bevacizumab can better control advanced ovarian cancer that expresses the HER2 protein, compared to using Bevacizumab alone. The trial will first conduct a safety phase to ensure the combination is safe before moving to the main study phase.
Description
Before the main part of the study begins, there will be an initial phase to check the safety of using Trastuzumab Deruxtecan with Bevacizumab. This is to make sure the combination is safe for patients before comparing it to Bevacizumab alone in the main study.
Eligibility Criteria
Inclusion Criteria
- Must sign consent forms before any trial-specific procedures.
- Adults aged 18 or older.
- Diagnosed with high-grade ovarian, fallopian tube, or primary peritoneal cancer.
- Newly diagnosed with advanced stage (FIGO Stage III or IV) cancer.
- Cancer must show HER2 protein expression based on specific testing guidelines.
- Must have enough tumor tissue available for HER2 testing.
- Must have results from local genetic tests for HRD or BRCA.
- Must have received standard treatment with Bevacizumab and platinum-based chemotherapy and be eligible to continue Bevacizumab alone.
Exclusion Criteria
- Cancer of non-epithelial origin.
- Has a BRCA mutation.
- Planned to receive a PARP inhibitor as maintenance treatment.
- Severe allergic reactions to study drugs or similar medications.
- Recent history of certain serious brain or bleeding conditions.
- Active or recent bowel obstruction.
- Significant lung or breathing issues, including recent pulmonary embolism or severe lung diseases.
- History of lung inflammation requiring steroids or current lung issues.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Scripps Clinic | 92037 | La Jolla | California |
| Broward Health Medical Center | 33316 | Fort Lauderdale | Florida |
| Jupiter Medical Center | 33458 | Jupiter | Florida |
| Mount Sinai Medical Center | 33140 | Miami Beach | Florida |
| AdventHealth Cancer Institute | 32804 | Orlando | Florida |
| Nancy N. & J.C Lewis Cancer & Research Pavillion- St. Josephs/ Candler Health System | 31405 | Savannah | Georgia |
| Indiana University | 46202 | Indianapolis | Indiana |
| Trials365 LLC | 71103 | Shreveport | Louisiana |
| Greater Baltimore Medical Center | 21204 | Towson | Maryland |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
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