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Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian Cancer
A Randomised, Open-label, Phase III Study of Torvutatug Samrotecan in Combination With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Treatment in Participants With Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (TREVI-OC-02)
Who can join
Ages 18 and older · Women
Full eligibility criteria
Key Inclusion Criteria: * Participants with newly diagnosed FIGO Stage III/IV, histologically confirmed epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma * Provision of an archival FFPE tumour sample * Participants who have completed at least 6 cycles and a maximum of 8 cycles of first-line Platinum-based chemotherapy (PBC) prior to randomisation * Participants must have received a minimum of 3 cycles of bevacizumab in combination with the 3 last cycles of PBC, prior to randomisation * Participants who have completed cytoreductive surgery or have inoperable disease * Participants with non-progressive disease upon completion of front-line induction therapy * HRD negative tumour Key Exclusion Criteria: * Participants with tumours of non-epithelial origin, borderline tumours, 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 * Participants with evidence of active or ongoing bowel obstruction * Prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)
About the study
This study will evaluate the efficacy, safety and tolerability of Torvutatug samrotecan (torvu-sam) in combination with bevacizumab compared with bevacizumab monotherapy as first line maintenance treatment in patients with Homologous Recombination Deficient (HRD) negative advanced ovarian cancer.
What is being tested
- Torvutatug samrotecan (drug)
- Bevacizumab (drug)
Sponsor: AstraZeneca · Participants: 950 · Started: Sep 16, 2026
Contact the study team
- AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479
Official record on ClinicalTrials.gov — NCT07851025
Locations in the U.S.
| Florida | Research Site, Tampa (Not yet recruiting) |
| Maryland | Research Site, Baltimore (Not yet recruiting) |
| Montana | Research Site, Billings (Not yet recruiting) |
| Ohio | Research Site, Cleveland (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Oct 5, 2026. Each study sets its own eligibility; the study team decides who can join.