Torvutatug samrotecan
DrugFRa targeting antibody drug conjugate Topoisomerase I inhibitor
Other names: AZD5335
NCT Number: NCT07816666
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)
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Phase 3
Research Site, Auchenflower, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FRa targeting antibody drug conjugate Topoisomerase I inhibitor
Other names: AZD5335
Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor
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.
Time frame: Up to approximately 5 years
OS is defined as time from randomisation until the date of death due to any cause.
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.
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.
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.
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).
Time frame: Up to approximately 5 years
Adverse Event Incidence
Trial opening soon.
Get NotifiedAstraZeneca
Industry
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
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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