Study on Torvutatug Samrotecan With or Without Bevacizumab for Maintenance Treatment of Platinum-sensitive Relapsed Ovarian Cancer
Sponsor: AstraZeneca
Sponsor score: 40
ClinicalTrials ID:NCT07816666
This clinical trial is testing the effectiveness and safety of a new drug, torvutatug samrotecan, with or without bevacizumab, compared to the usual treatment for women with ovarian cancer that has returned and responds to platinum-based chemotherapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to evaluate how well the drug torvutatug samrotecan, either alone or combined with bevacizumab, works as a maintenance treatment for women whose ovarian cancer has returned but still responds to platinum-based chemotherapy. The study will compare this new treatment to the standard care currently used for such cases.
Eligibility Criteria
Inclusion Criteria
- Women with confirmed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Must provide a previous tumor sample for analysis.
- Have received at least one, but no more than two, previous cancer treatments.
- Cancer must have returned at least 6 months after the last platinum chemotherapy treatment.
- Have completed 4-6 cycles of platinum-based chemotherapy in their current treatment phase.
- If assigned to receive bevacizumab, must have had at least 3 cycles of bevacizumab with 3 cycles of platinum-based chemotherapy before starting the study.
- Cancer must not be progressing after completing the current chemotherapy.
- If they have a BRCA 1/2 mutation, must have previously received a PARP inhibitor unless unable to due to medical reasons.
Exclusion Criteria
- Have tumors that are not epithelial in origin, or have borderline, clear cell, mucinous, carcinosarcoma, or low-grade epithelial tumors.
- Have a history of lung conditions like ILD/pneumonitis that needed steroids or oxygen, or currently have these conditions.
- Have a non-healing wound, active ulcer, or bone fracture (if receiving bevacizumab).
- Have an active or ongoing bowel obstruction (if receiving bevacizumab).
- Have previously been treated with any FRα-targeted therapy or certain antibody-drug conjugates.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 99508 | Anchorage | Alaska |
| Research Site | 33133 | Miami | Florida |
| Research Site | 46260 | Indianapolis | Indiana |
| Research Site | 71103 | Shreveport | Louisiana |
| Research Site | 21044 | Columbia | Maryland |
| Research Site | 48109 | Ann Arbor | Michigan |
| Research Site | 48201 | Detroit | Michigan |
| Research Site | 12206 | Albany | New York |
| Research Site | 11706 | Bay Shore | New York |
| Research Site | 14263 | Buffalo | New York |
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