Ireland
--:--IST
Recruiting Phase 3

Torvutatug Samrotecan With or Without Bevacizumab as Maintenance Treatment of Platinum-sensitive Relapsed Epithelial Ovarian Cancer

NCT07816666 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2026-09-24
Last updated
2026-10-16

Condition(s) studied

Platinum-sensitive Relapsed Epithelial Ovarian CancerPlatinum-sensitive Relapsed Fallopian Tube CancerPlatinum-sensitive Relapsed Primary Peritoneal Cancer

Investigational drug(s) / intervention(s)

Torvutatug samrotecan →Bevacizumab →

Torvutatug samrotecan: FRa targeting antibody drug conjugate Topoisomerase I inhibitor

Bevacizumab: Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor

Study summary

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)

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 4-6 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)

Primary outcome measure(s)

  • Progression-Free Survival (PFS) — Up to approximately 5 years
    PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review, or death due to any cause.

Trial sites (124)

FacilityCityRegionStatus
Research Site Anchorage Alaska Not Yet Recruiting
Research Site Miami Florida Not Yet Recruiting
Research Site Indianapolis Indiana Not Yet Recruiting
Research Site Shreveport Louisiana Not Yet Recruiting
Research Site Columbia Maryland Not Yet Recruiting
Research Site Ann Arbor Michigan Not Yet Recruiting
Research Site Detroit Michigan Not Yet Recruiting
Research Site Albany New York Not Yet Recruiting
Research Site Bay Shore New York Withdrawn
Research Site Buffalo New York Not Yet Recruiting
Research Site Greenlawn New York Withdrawn
Research Site New Hyde Park New York Withdrawn
Research Site New York New York Not Yet Recruiting
Research Site New York New York Not Yet Recruiting
Research Site Rego Park New York Withdrawn
Research Site Cleveland Ohio Not Yet Recruiting
Research Site Cleveland Ohio Not Yet Recruiting
Research Site Columbus Ohio Withdrawn
Research Site Mayfield Heights Ohio Not Yet Recruiting
Research Site Oklahoma City Oklahoma Withdrawn
Research Site Philadelphia Pennsylvania Not Yet Recruiting
Research Site Willow Grove Pennsylvania Not Yet Recruiting
Research Site Houston Texas Not Yet Recruiting
Research Site Salt Lake City Utah Not Yet Recruiting
Research Site Norfolk Virginia Not Yet Recruiting
Research Site Morgantown West Virginia Not Yet Recruiting
Research Site Auchenflower Australia Not Yet Recruiting
Research Site Blacktown Australia Not Yet Recruiting
Research Site Clayton Australia Not Yet Recruiting
Research Site Liverpool Australia Not Yet Recruiting
Research Site Porto Alegre Brazil Not Yet Recruiting
Research Site São Caetano do Sul Brazil Not Yet Recruiting
Research Site São José do Rio Preto Brazil Not Yet Recruiting
Research Site São José dos Campos Brazil Not Yet Recruiting
Research Site São Paulo Brazil Not Yet Recruiting
Research Site Teresina Brazil Not Yet Recruiting
Research Site Vitória Brazil Not Yet Recruiting
Research Site Abbotsford British Columbia British Columbia Not Yet Recruiting
Research Site Montreal Quebec Not Yet Recruiting
Research Site Montreal Quebec Not Yet Recruiting

+ 84 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07816666 on ClinicalTrials.gov ↗ ← All trials in Japan