Torvutatug Samrotecan plus bevacizumab as first-line maintenance in Homologous Recombination Deficiency (HRD) negative advanced epithelial ovarian cancer - TREVI-OC-02
Study identifier:D8994C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:2026-526895-22-00
Recruiting
Official Title
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)
Medical condition
Epithelial ovarian cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
Torvutatug samrotecan, Bevacizumab
Sex
Female
Estimated Enrollment
950
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 16 Sept 2026
Estimated Primary Completion Date: 18 Jun 2030
Estimated Study Completion Date: 17 Aug 2033
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2026 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
European Network of Gynecological Oncological Trial Groups (ENGOT), GOG Foundation, Inc. (GOG Foundation)
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Torvutatug samrotecan + Bevacizumab Torvutatug samrotecan IV (intravenous) + Bevacizumab IV | Drug: Torvutatug samrotecan Antibody drug conjugate Other Name: AZD5335 Other Name: Torvu-sam Drug: Bevacizumab Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor Other Name: Antiangiogenic therapy |
| Active Comparator: Bevacizumab Bevacizumab IV | Drug: Bevacizumab Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor Other Name: Antiangiogenic therapy |
