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Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian Cancer

RecruitingPhase 3

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

Sponsor: AstraZeneca · Participants: 950 · Started: Sep 16, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07851025

Locations in the U.S.

FloridaResearch Site, Tampa (Not yet recruiting)
MarylandResearch Site, Baltimore (Not yet recruiting)
MontanaResearch Site, Billings (Not yet recruiting)
OhioResearch 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.