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Clinical Trials in the USA / NCT07816666
Starting soon 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 USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2026-09-29
Last updated
2026-09-14

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 samrotecanBevacizumab

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 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)

Primary outcome measure(s)

Trial sites (79)

FacilityCityRegionStatus
Research Site Anchorage Alaska
Research Site Columbia Maryland
Research Site Detroit Michigan
Research Site Albany New York
Research Site Bay Shore New York
Research Site Greenlawn New York
Research Site New Hyde Park New York
Research Site New York New York
Research Site Rego Park New York
Research Site Cleveland Ohio
Research Site Cleveland Ohio
Research Site Columbus Ohio
Research Site Mayfield Heights Ohio
Research Site Philadelphia Pennsylvania
Research Site Willow Grove Pennsylvania
Research Site Morgantown West Virginia
Research Site Auchenflower Australia
Research Site Blacktown Australia
Research Site Clayton Australia
Research Site Liverpool Australia
Research Site Porto Alegre Brazil
Research Site São Caetano do Sul Brazil
Research Site São José do Rio Preto Brazil
Research Site São José dos Campos Brazil
Research Site São Paulo Brazil
Research Site Teresina Brazil
Research Site Vitória Brazil
Research Site Abbotsford British Columbia British Columbia
Research Site Montreal Quebec
Research Site Montreal Quebec
Research Site Beijing China
Research Site Guangdong Province China
Research Site Guangzhou China
Research Site Wuhan China
Research Site Bad Homburg Germany
Research Site Bonn Germany
Research Site Brandenburg Germany
Research Site Gütersloh Germany
Research Site Homburg Germany
Research Site Kassel Germany

+ 39 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 the USA