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Torvutatug Samrotecan With or Without Bevacizumab as Maintenance Treatment of Platinum-sensitive Relapsed Epithelial Ovarian Cancer
A Randomised, Open-label, Phase III Study of Torvutatug Samrotecan With or Without Bevacizumab Versus Standard of Care as Second- or Third-Line Maintenance Treatment in Participants With Platinum-sensitive Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (TREVI-OC-03)
Who can join
Ages 18 and older · Women
Full eligibility criteria
Inclusion Criteria: * Participants with confirmed histology of high-grade epithelial serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer. * Provision of an archival FFPE tumour sample * Participants who received at least one, and no more than 2 lines of prior systemic anticancer therapy. * Participants with radiologically confirmed disease relapse ≥ 6 months after their last platinum chemotherapy infusion in the previous line of treatment * Participants who received 4-6 cycles of PBC during the induction phase of their current line of treatment. * Participants assigned to bevacizumab must have received a minimum of 3 cycles of bevacizumab with 3 cycles of PBC prior to randomisation. * Participants with non-progressive disease upon completion of PBC in their current line of treatment. * Participants with documented BRCA mutation 1/2 must have received prior PARP inhibitor (unless ineligible due to contraindications, precautions, or intolerance). Exclusion Criteria: * Participants with tumours of non-epithelial origin, borderline tumours, clear cell OC, mucinous OC, carcinosarcoma, or low-grade epithelial tumours. * Participants with history of (non-infectious) ILD/pneumonitis that required steroids, or supplemental oxygen, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening * Participants with non-healing wound, active ulcer, or bone fracture (not applicable if not receiving bevacizumab) * Participants with evidence of active or ongoing bowel obstruction (not applicable if not receiving bevacizumab) * Participants with prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)
About the study
The purpose of this study is to measure the efficacy and safety of torvutatug samrotecan (torvu-sam) with or without bevacizumab compared to standard of care (SoC) as maintenance treatment in participants with platinum-sensitive relapsed ovarian cancer (PSR OC)
What is being tested
- Torvutatug samrotecan (drug)
- Bevacizumab (drug)
Sponsor: AstraZeneca · Participants: 600 · Started: Sep 24, 2026
Contact the study team
- AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479
Official record on ClinicalTrials.gov — NCT07816666
Locations in the U.S.
| Alaska | Research Site, Anchorage (Not yet recruiting) |
| Florida | Research Site, Miami (Not yet recruiting) |
| Indiana | Research Site, Indianapolis (Not yet recruiting) |
| Louisiana | Research Site, Shreveport (Not yet recruiting) |
| Maryland | Research Site, Columbia (Not yet recruiting) |
| Michigan | Research Site, Ann Arbor (Not yet recruiting) Research Site, Detroit (Not yet recruiting) |
| New York | Research Site, Albany (Not yet recruiting) Research Site, Buffalo (Not yet recruiting) Research Site, New York (Not yet recruiting) Research Site, New York (Not yet recruiting) |
| Ohio | Research Site, Cleveland (Not yet recruiting) Research Site, Cleveland (Not yet recruiting) Research Site, Mayfield Heights (Not yet recruiting) |
| Pennsylvania | Research Site, Philadelphia (Not yet recruiting) Research Site, Willow Grove (Not yet recruiting) |
| Texas | Research Site, Houston (Not yet recruiting) |
| Utah | Research Site, Salt Lake City (Not yet recruiting) |
| Virginia | Research Site, Norfolk (Not yet recruiting) |
| West Virginia | Research Site, Morgantown (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.