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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
FRa targeting antibody drug conjugate Topoisomerase I inhibitor
Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor
Progression-Free Survival (PFS)
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
Overall Survival (OS)
OS is defined as time from randomisation until the date of death due to any cause.
Time frame: Up to approximately 5 years
Second Progression-Free Survival (PFS2)
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
Time to First Subsequent Therapy (TFST)
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
Time to Second Subsequent Therapy (TSST)
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
Health-related Quality of Life (HrQoL)
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
Number and percentage of participants with adverse events as graded by CTCAE v6 criteria
AstraZeneca Clinical Study Information Center
CONTACT
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Research Site
Anchorage, Alaska, United States
Research Site
Columbia, Maryland, United States
Research Site
Detroit, Michigan, United States
Research Site
Albany, New York, United States
Research Site
Bay Shore, New York, United States
Research Site
Greenlawn, New York, United States
Research Site
New Hyde Park, New York, United States
Research Site
New York, New York, United States
Research Site
Rego Park, New York, United States
Research Site
Cleveland, Ohio, United States
...and 69 more locations
Adverse Event Incidence
Time frame: Up to approximately 5 years