NCT07816666 · AstraZeneca
Torvutatug Samrotecan With or Without Bevacizumab as Maintenance Treatment of Platinum-sensitive Relapsed Epithelial Ovarian Cancer
(TREVI-OC-03)
What this study is about
The purpose of this study is to measure the effectiveness and safety of torvutatug samrotecan (torvu-sam) with or without bevacizumab compared to the usual treatment (SoC) as maintenance treatment in participants with platinum-sensitive relapsed ovarian cancer (PSR OC)
View original scientific 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)
Interventions
DRUG
Torvutatug samrotecan
FRa targeting antibody drug conjugate Topoisomerase I inhibitor
DRUG
Bevacizumab
Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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 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)
Where
- Anchorage, Alaska
- Miami, Florida
- Indianapolis, Indiana
- Shreveport, Louisiana
- Columbia, Maryland
- Ann Arbor, Michigan
- Detroit, Michigan
- Albany, New York
- Bay Shore, New York
- Buffalo, New York
- Greenlawn, New York
- New Hyde Park, New York
And 12 more locations — see the full list below.
Collaborators
GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Ventana Medical Systems, Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 16, 2026 · Source of record for eligibility and locations