Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian Cancer (TREVI-OC-02)

AstraZeneca

Status and phase: Enrolling; Phase 3

Conditions: Epithelial Ovarian Cancer

Treatments: Drug: Torvutatug samrotecan; Drug: Bevacizumab

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT07851025

D8994C00001

2026-526895-22-00 (EU Trial (CTIS) Number)

180099 (Registry Identifier)

ENGOT-ov110 (Other Identifier)

GOG-3149 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This study aims to see if torvu-sam in combination with bevacizumab allows patients to live longer without the cancer getting worse, compared to patients receiving bevacizumab.

Eligible patients will be those patients who have not progressed following completion of first line induction treatment with Platinum-based chemotherapy (PBC) and bevacizumab. All patients must be HRD-negative through pre-existing study approved local test or prospective central test and have a confirmed folate receptor alpha status determined by prospective central test.

Enrollment: 950 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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950 participants in 2 patient groups

Torvutatug samrotecan + Bevacizumab

Experimental group

Description:

Torvutatug samrotecan IV (intravenous) + Bevacizumab IV

Treatment:

Drug: Bevacizumab

Drug: Torvutatug samrotecan

Bevacizumab

Active Comparator group

Description:

Bevacizumab IV

Treatment:

Drug: Bevacizumab