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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
Chiba, Fukuoka, Fukushima, Gifu, Hidaka-shi, Ichihara, Kagoshima, Kobe, Kōtoku, Kurume-shi, Kyoto, Minatoku, Natori-shi, Sagamihara-shi, Shinjuku-ku, Suita-shi, Toyoake-shi, and Yokohama, JapanSee the 18 sites
Phase
Phase 3

Where in Japan

  • ChibaChiba, JapanNot yet recruiting
  • FukuokaFukuoka, JapanNot yet recruiting
  • FukushimaFukushima, JapanNot yet recruiting
  • GifuGifu, JapanNot yet recruiting
  • Hidaka-shiHidaka-shi, JapanNot yet recruiting
  • IchiharaIchihara, JapanNot yet recruiting
  • KagoshimaKagoshima, JapanNot yet recruiting
  • KobeKobe, JapanNot yet recruiting
  • KōtokuKōtoku, JapanNot yet recruiting
  • Kurume-shiKurume-shi, JapanNot yet recruiting
  • KyotoKyoto, JapanNot yet recruiting
  • MinatokuMinatoku, JapanNot yet recruiting
  • Natori-shiNatori-shi, JapanNot yet recruiting
  • Sagamihara-shiSagamihara-shi, JapanNot yet recruiting
  • Shinjuku-kuShinjuku-ku, JapanNot yet recruiting
  • Suita-shiSuita-shi, JapanNot yet recruiting
  • Toyoake-shiToyoake-shi, JapanNot yet recruiting
  • YokohamaYokohama, JapanNot 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