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Recruiting NCT07851025

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

Conditions: Epithelial Ovarian Cancer

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 950
Sponsor: AstraZeneca

Location: Research Site Tampa Florida

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 Homologous Recombination Deficient (HRD) negative 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 * 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07851025). StuddyBuddy aggregates publicly available trial information.