This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \[IHC\] 3+/2+/1+) advanced high-grade epithelial ovarian cancer.
A non-randomized safety run-in phase will be conducted prior to randomization phase to assess the safety of T-DXd in combination with bevacizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
582
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W
Progression Free Survival by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ population
Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.
Time frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
Overall Survival in the HER2 IHC 3+/2+ population
Time interval from the date of randomization to the date of death due to any cause.
Time frame: From date of randomization to death due to any cause, up to approximately 72 months
Progression Free Survival by BICR in the HER2 IHC 3+/2+/1+ population
Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.
Time frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
Overall Survival in the HER2 IHC 3+/2+/1+ population
Time interval from the date of randomization to the date of death due to any cause.
Time frame: From date of randomization to death due to any cause, up to approximately 72 months
Progression Free Survival by the investigator in HER2 IHC 3+/2+ population
Time from randomization to time of objective radiographic disease progression as assessed by the investigator based on RECIST v1.1 or death due to any cause.
Time frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
Progression Free Survival by the investigator in HER2 IHC 3+/2+/1+ population
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RECRUITING...and 128 more locations
Time from randomization to time of objective radiographic disease progression as assessed by the investigator based on RECIST v1.1 or death due to any cause.
Time frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months