NCT07851025 Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
| NCT ID | NCT07851025 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AstraZeneca |
| Condition | Epithelial Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 950 participants |
| Start Date | 2026-09-16 |
| Primary Completion | 2030-06-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 950 participants in total. It began in 2026-09-16 with a primary completion date of 2030-06-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 Key Exclusion Criteria: * 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 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07851025 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Epithelial Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07851025 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 950 participants.
Is NCT07851025 currently recruiting?
Yes, NCT07851025 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07851025 trial being conducted?
This trial is being conducted at Tamarac, United States, Tampa, United States, Baton Rouge, United States, Baltimore, United States and 11 additional locations.
Who is sponsoring the NCT07851025 clinical trial?
NCT07851025 is sponsored by AstraZeneca. The trial plans to enroll 950 participants.
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