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Taking peoplePhase 3

Torvutatug Samrotecan, With or Without Bevacizumab, as Ongoing Treatment for Relapsed Ovarian Cancer

Tests torvutatug samrotecan in adults whose platinum-sensitive ovarian cancer has returned.

Plain-language title generated from the registry record
Registry title: Torvutatug Samrotecan With or Without Bevacizumab as Maintenance Treatment of Platinum-sensitive Relapsed Epithelial Ovarian Cancer

Key facts

Where
Bad Homburg, Bonn, Brandenburg, Dresden, Düsseldorf, Essen, Gütersloh, Halle, Hamburg, Homburg, Kassel, Mainz, Mannheim, Münster, Schweinfurt, Wiesbaden, and Wuppertal, GermanySee the 17 sites
Phase
Phase 3

Where in Germany

  • Bad HomburgBad Homburg, GermanyNot yet recruiting
  • BonnBonn, GermanyNot yet recruiting
  • BrandenburgBrandenburg, GermanyNot yet recruiting
  • DresdenDresden, GermanyNot yet recruiting
  • DüsseldorfDüsseldorf, GermanyNot yet recruiting
  • EssenEssen, GermanyNot yet recruiting
  • GüterslohGütersloh, GermanyNot yet recruiting
  • HalleHalle, GermanyNot yet recruiting
  • HamburgHamburg, GermanyNot yet recruiting
  • HomburgHomburg, GermanyNot yet recruiting
  • KasselKassel, GermanyNot yet recruiting
  • MainzMainz, GermanyNot yet recruiting
  • MannheimMannheim, GermanyNot yet recruiting
  • MünsterMünster, GermanyNot yet recruiting
  • SchweinfurtSchweinfurt, GermanyNot yet recruiting
  • WiesbadenWiesbaden, GermanyNot yet recruiting
  • WuppertalWuppertal, GermanyNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
AstraZeneca
Trial code
NCT07816666EU 2026-526776-23-00
Record updated
16 October 2026
Original description
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)Read full original descriptionShow less

A Randomised, Open-label, Phase III Study of Torvutatug Samrotecan With or Without Bevacizumab Versus Standard of Care as Second- or Third-Line Maintenance Treatment in Participants With Platinum-sensitive Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (TREVI-OC-03)

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)

Inclusion: 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: 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); 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 tumours of non-epithelial origin, borderline tumours, clear cell OC, mucinous OC, carcinosarcoma, or low-grade epithelial tumours.

ClinicalTrials.gov NCT07816666 · EU CTIS 2026-526776-23-00