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NCT Number: NCT07816666

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

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)

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Torvutatug samrotecan

Drug

FRa targeting antibody drug conjugate Topoisomerase I inhibitor

Other names: AZD5335

Bevacizumab

Drug

Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 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.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 5 years

    OS is defined as time from randomisation until the date of death due to any cause.

  2. Second Progression-Free Survival (PFS2)

    Time frame: Up to approximately 5 years

    PFS2 is defined as time from randomisation to the earliest of the progression event (following the initial investigator-assessed progression) after first subsequent therapy, or death.

  3. Time to First Subsequent Therapy (TFST)

    Time frame: Up to approximately 5 years

    TFST is defined as time from randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.

  4. Time to Second Subsequent Therapy (TSST)

    Time frame: Up to approximately 5 years

    TSST is defined as time from randomisation until the start date of the second subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.

  5. Health-related Quality of Life (HrQoL)

    Time frame: Up to approximately 5 years

    Change from baseline and time to deterioration in global health status/quality of life (GHS/QoL), physical functioning (PF), and ovarian cancer symptoms (EORTC IL433).

  6. Number and percentage of participants with adverse events as graded by CTCAE v6 criteria

    Time frame: Up to approximately 5 years

    Adverse Event Incidence

Interested in participating?

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Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • GOG Foundation
  • Ventana Medical Systems, Inc

Registry information

Official study title

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)

Acronym: TREVI-OC-03

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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