NCT07851025 · AstraZeneca
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian Cancer
(TREVI-OC-02)
What this study is about
This study will evaluate the effectiveness, safety and how well patients handle the treatment of Torvutatug samrotecan (torvu-sam) in combination with bevacizumab compared with bevacizumab treatment given alone as first line maintenance treatment in patients with Homologous Recombination Deficient (HRD) negative advanced ovarian cancer.
View original scientific description
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 Homologous Recombination Deficient (HRD) negative advanced ovarian cancer.
Interventions
DRUG
Torvutatug samrotecan
Antibody drug conjugate
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 the time from randomization to radiographic progression as assessed by BICR per RECIST v1.1, 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 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
- HRD negative tumour Key
Exclusion criteria
- Participants with tumours of non-epithelial origin, borderline tumours, 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
- Participants with evidence of active or ongoing bowel obstruction
- Prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)
Where
- Tampa, Florida
- Baltimore, Maryland
- Billings, Montana
- Cleveland, Ohio
Collaborators
European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation
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 1, 2026 · Source of record for eligibility and locations