Torvutatug Samrotecan With or Without Bevacizumab as Maintenance Treatment of Platinum-sensitive Relapsed Epithelial Ovarian Cancer (TREVI-OC-03)

AstraZeneca

Status and phase: Begins enrollment this month; Phase 3

Conditions: Platinum-sensitive Relapsed Fallopian Tube Cancer; Platinum-sensitive Relapsed Epithelial Ovarian Cancer; Platinum-sensitive Relapsed Primary Peritoneal Cancer

Treatments: Drug: Bevacizumab; Drug: Torvutatug samrotecan

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT07816666

D8992C00001

2026-526776-23-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The purpose of this study is to measure the efficacy and safety of torvutatug samrotecan (torvu-sam) with or without bevacizumab compared to standard of care (SoC) as maintenance treatment in participants with platinum-sensitive relapsed ovarian cancer (PSR OC)

Enrollment: 600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with confirmed histology of high-grade epithelial serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer.
• Provision of an archival FFPE tumour sample
• Participants who received at least one, and no more than 2 lines of prior systemic anticancer therapy.
• Participants with radiologically confirmed disease relapse ≥ 6 months after their last platinum chemotherapy infusion in the previous line of treatment
• Participants who received at least 6 cycles of PBC during the induction phase of their current line of treatment.
• Participants assigned to bevacizumab must have received a minimum of 3 cycles of bevacizumab with 3 cycles of PBC prior to randomisation.
• Participants with non-progressive disease upon completion of PBC in their current line of treatment.
• Participants with documented BRCA mutation 1/2 must have received prior PARP inhibitor (unless ineligible due to contraindications, precautions, or intolerance).

Exclusion criteria

• Participants with tumours of non-epithelial origin, borderline tumours, clear cell OC, mucinous OC, carcinosarcoma, 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 (not applicable if not receiving bevacizumab)
• Participants with evidence of active or ongoing bowel obstruction (not applicable if not receiving bevacizumab)
• Participants with 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: None (Open label)

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600 participants in 2 patient groups

Torvutatug samrotecan monotherapy or in combination with bevacizumab

Experimental group

Description:

Torvutatug samrotecan monotherapy intravenous (IV) or Torvutatug samrotecan IV with bevacizumab IV.

Treatment:

Drug: Torvutatug samrotecan

Drug: Bevacizumab

Observation or bevacizumab

Active Comparator group

Description:

Observation or bevacizumab IV.

Treatment:

Drug: Bevacizumab