Torvutatug Samrotecan With or Without Bevacizumab as Maintenance Treatment of Platinum-sensitive Relapsed Epithelial Ovarian Cancer (TREVI-OC-03)

September 7, 2026 updated by: AstraZeneca

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Auchenflower, Australia, 4066
        • Research Site
      • Blacktown, Australia, 2148
        • Research Site
      • Clayton, Australia, 3168
        • Research Site
      • Liverpool, Australia, 2170
        • Research Site
  • Brazil
      • Porto Alegre, Brazil, 90035903
        • Research Site
      • São Caetano do Sul, Brazil, 09541-270
        • Research Site
      • São José do Rio Preto, Brazil, 15090-000
        • Research Site
      • São José dos Campos, Brazil, 12210-030
        • Research Site
      • São Paulo, Brazil, 01327-001
        • Research Site
      • Teresina, Brazil, 64049-200
        • Research Site
      • Vitória, Brazil, 29043-260
        • Research Site
  • Canada
    • British Columbia
      • Abbotsford British Columbia, British Columbia, Canada, V2S0C2
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Research Site
      • Montreal, Quebec, Canada, H2X 0A9
        • Research Site
  • China
      • Beijing, China, 100210
        • Research Site
      • Guangdong Province, China, 510060
        • Research Site
      • Guangzhou, China, 510060
        • Research Site
      • Wuhan, China, 430030
        • Research Site
  • Germany
      • Bad Homburg, Germany, 61352
        • Research Site
      • Bonn, Germany, 53127
        • Research Site
      • Brandenburg, Germany, 14770
        • Research Site
      • Gütersloh, Germany, 33332
        • Research Site
      • Homburg, Germany, 66421
        • Research Site
      • Kassel, Germany, 34125
        • Research Site
      • Mainz, Germany, 55131
        • Research Site
      • Mannheim, Germany, 68167
        • Research Site
      • Wiesbaden, Germany, 65189
        • Research Site
  • India
      • Ahmedabad, India, 380060
        • Research Site
      • Bangalore, India, 560004
        • Research Site
      • Gurgaon, India, 122002
        • Research Site
      • Kottayam, India, 686008
        • Research Site
      • Madurai, India, 625107
        • Research Site
      • Nashik, India, 422002
        • Research Site
      • Nashik, India, 422 009
        • Research Site
      • New Delhi, India, 11029
        • Research Site
      • Vadodara, India, 391760
        • Research Site
  • Japan
      • Fukuoka, Japan, 812-8582
        • Research Site
      • Fukushima, Japan, 960-1295
        • Research Site
      • Kobe, Japan, 650-0047
        • Research Site
      • Kyoto, Japan, 612-8555
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Research Site
      • Minatoku, Japan, 105-8471
        • Research Site
      • Natori-shi, Japan, 981-1293
        • Research Site
      • Sagamihara-shi, Japan, 252-0375
        • Research Site
      • Shinjuku-ku, Japan, 160-0023
        • Research Site
      • Suita-shi, Japan, 565-0871
        • Research Site
      • Toyoake-shi, Japan, 470-1192
        • Research Site
      • Yokohama, Japan, 236-0004
        • Research Site
  • South Korea
      • Goyang-si, South Korea, 10408
        • Research Site
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 03722
        • Research Site
      • Seoul, South Korea, 135-710
        • Research Site
      • Seoul, South Korea, 5505
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
      • Tainan, Taiwan, 70403
        • Research Site
      • Taipei, Taiwan, 10449
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10210
        • Research Site
      • Bangkok, Thailand, 10330
        • Research Site
      • Bangkok, Thailand, 10700
        • Research Site
      • Hat Yai, Thailand, 90110
        • Research Site
      • Muang, Thailand, 50200
        • Research Site
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Research Site
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Research Site
    • New York
      • Albany, New York, United States, 12206
        • Research Site
      • Bay Shore, New York, United States, 11706
        • Research Site
      • Greenlawn, New York, United States, 11740
        • Research Site
      • New Hyde Park, New York, United States, 11042
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
      • Rego Park, New York, United States, 11374
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Research Site
      • Cleveland, Ohio, United States, 44111
        • Research Site
      • Columbus, Ohio, United States, 43210
        • Research Site
      • Mayfield Heights, Ohio, United States, 44124
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Research Site
      • Willow Grove, Pennsylvania, United States, 19090
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Torvutatug samrotecan monotherapy or in combination with bevacizumab
Torvutatug samrotecan monotherapy intravenous (IV) or Torvutatug samrotecan IV with bevacizumab IV.
Drug: Torvutatug samrotecan
FRa targeting antibody drug conjugate Topoisomerase I inhibitor
Other Names:
  • AZD5335
Drug: Bevacizumab
Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor
Active Comparator: Observation or bevacizumab
Observation or bevacizumab IV.
Drug: Bevacizumab
Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 5 years
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.
Up to approximately 5 years
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.
Up to approximately 5 years
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.
Up to approximately 5 years
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).
Up to approximately 5 years
Number and percentage of participants with adverse events as graded by CTCAE v6 criteria
Time Frame: Up to approximately 5 years
Adverse Event Incidence
Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 29, 2026

Primary Completion (Estimated)

September 26, 2028

Study Completion (Estimated)

October 27, 2031

Study Registration Dates

First Submitted

September 7, 2026

First Submitted That Met QC Criteria

September 7, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 7, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8992C00001
  • 2026-526776-23-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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