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Torvutatug samrotecan with bevacizumab as ongoing treatment after first treatment for advanced ovarian cancer

Compares torvutatug samrotecan plus bevacizumab with bevacizumab alone in advanced ovarian cancer.

Key facts

Who runs it
AstraZeneca
Where
Cambridge, United KingdomSee the siteAlso in 28 other countries, 172 sites
Registry title
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Status
Recruiting
Phase
Phase 3
People taking part
950 people, planned
Started
16 Sept 2026
Expected to end
29 Aug 2033
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Torvutatug samrotecan
  • Bevacizumab
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with newly diagnosed advanced ovarian, fallopian tube or primary peritoneal cancer whose tumour is non-HRD. They must have finished first-line platinum chemotherapy with bevacizumab.

Age
18 years or older
Sex
Women only
Disease stage
Newly diagnosed FIGO Stage III/IV high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer. The disease has not got worse after first-line treatment. Surgery to remove the tumour is done, or the disease cannot be operated on.
Earlier treatment
Must have finished 6 to 8 cycles of first-line platinum-based chemotherapy. Must have had at least 3 cycles of bevacizumab together with the last 3 cycles of chemotherapy. Cannot have had any FRα-targeted therapy (including MIRV) or any TOP1i antibody-drug conjugate before.
Biomarker or test result
Tumour must be non-HRD. A BRCA1/2 mutation, HRD-positive, unknown or unclear tumour status means the person cannot join. An archived tumour sample must be provided.

Main reasons for not taking part

  • Tumours that are not epithelial, borderline tumours, or low-grade epithelial tumours
  • BRCA1/2 mutation, or HRD-positive, unknown or unclear tumour status
  • Past or current lung inflammation (ILD/pneumonitis) that needed steroids or extra oxygen
  • A wound that does not heal, an active ulcer, or a bone fracture
  • Active or ongoing bowel obstruction

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Participants with newly diagnosed FIGO Stage III/IV, histologically confirmed epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma
  • Provision of an archival FFPE tumour sample
  • Participants who have completed at least 6 cycles and a maximum of 8 cycles of first-line Platinum-based chemotherapy (PBC) prior to randomisation
  • Participants must have received a minimum of 3 cycles of bevacizumab in combination with the 3 last cycles of PBC, prior to randomisation
  • Participants who have completed cytoreductive surgery or have inoperable disease
  • Participants with non-progressive disease upon completion of front-line induction therapy

Who cannot take part

  • 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 non-healing wound, active ulcer, or bone fracture
  • Participants with tumours of non-epithelial origin, borderline tumours, or low-grade epithelial tumours
  • BRCA1/2 mutation (germline or somatic) or HRD positive, unknown, or inconclusive tumour status
  • Participants with evidence of active or ongoing bowel obstruction

Where in United Kingdom

Also in 28 other countries, 172 sites

  • CambridgeHospital not named in the registryNot yet recruiting

About the trial

What the trial wants to find out

This study will evaluate the efficacy, safety and tolerability of Torvutatug samrotecan (torvu-sam) in combination with bevacizumab compared with bevacizumab monotherapy as first line maintenance treatment in patients with non-Homologous Recombination Deficient (non-HRD) positive advanced ovarian cancer.

The 2 groups in the trial

  • Torvutatug samrotecan + BevacizumabTreatment being tested

    Torvutatug samrotecan IV (intravenous) + Bevacizumab IV

    Treatment: Torvutatug samrotecan and Bevacizumab

  • BevacizumabExisting treatment, for comparison

    Bevacizumab IV

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?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Randomised, Open-label, Phase III Study of Torvutatug Samrotecan in Combination With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Treatment in Participants With Non-HRD Positive Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (TREVI-OC-02)
Plain-language title
Torvutatug samrotecan with bevacizumab as ongoing treatment after first treatment for advanced ovarian cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 November 2026