Torvutatug samrotecan with bevacizumab as ongoing treatment after first treatment for advanced ovarian cancer
Compares torvutatug samrotecan plus bevacizumab with bevacizumab alone in advanced ovarian cancer.
Plain-language title generated from the registry record
Registry title: Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Key facts
- Where
- Buenos Aires, Capital Federal, Ciudad de Buenos Aires, Córdoba, Rosario, Salta, Santa Fe, and Viedma, ArgentinaSee the 8 sites
- Phase
- Phase 3
Where in Argentina
- Buenos AiresBuenos Aires, ArgentinaNot yet recruiting
- Capital FederalCapital Federal, ArgentinaNot yet recruiting
- Ciudad de Buenos AiresCiudad de Buenos Aires, ArgentinaNot yet recruiting
- CórdobaCórdoba, ArgentinaNot yet recruiting
- RosarioRosario, ArgentinaNot yet recruiting
- SaltaSalta, ArgentinaNot yet recruiting
- Santa FeSanta Fe, ArgentinaNot yet recruiting
- ViedmaViedma, ArgentinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07851025EU 2026-526895-22-00
- Record updated
- 6 November 2026
- Original description
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 non-Homologous Recombination Deficient (non-HRD) positive advanced ovarian cancer.Read full original descriptionShow less
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 Non-HRD Positive Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (TREVI-OC-02)
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 non-Homologous Recombination Deficient (non-HRD) positive advanced ovarian cancer.
Inclusion: 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.
Exclusion: Prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC); 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 tumours of non-epithelial origin, borderline tumours, or low-grade epithelial tumours; BRCA1/2 mutation (germline or somatic) or HRD positive, unknown, or inconclusive tumour status; Participants with evidence of active or ongoing bowel obstruction.