A phase 2, open-label, Multicenter, Randomized study of Trastuzumab Deruxtecan versus investigator’s choice chemotherapy in recurrent ovarian cancer that progressed on prior PARP inhibitor therapy: TROY (APGOT-OV14)

Condition studied

Ovarian cancer

Investigational medicinal product(s)

Every trial of Trastuzumab deruxtecan and Bevacizumab across our registers →

Eligibility

Primary endpoint

Progression Free Survival (PFS) in HER2 IHC 1+/2+/3+ population Defined as the time from the date of randomization until first documentation of disease progression, as determined by investigator assessment based on RECIST 1.1, or death due to any cause, whichever occurs first.

Endpoint detail

Progression Free Survival (PFS) in HER2 IHC 2+/3+ population. Defined as the time from the date of randomization until first documentation of disease progression, as determined by investigator assessment based on RECIST 1.1, or death due to any cause, whichever occurs first., Objective Response Rate (ORR) by investigator in HER2 2+/3+ population. Defined as the proportion of patients who have best overall response of either complete response (CR) or partial response (PR), as investigator assessment based on RECIST 1.1, Objective Response Rate (ORR) by investigator in HER2 1+/2+/3+ population. Defined as the proportion of patients who have best overall response of either complete response (CR) or partial response (PR), as investigator assessment based on RECIST 1.1, Disease control rate (DCR) by investigator in HER2 2+/3+ population. Defined as the proportion of patients who have best overall response of CR, PR, or stable disease (SD) by APGOT-OV14– TROY – Protocol – Version 2.0_27Jun2025 Page 27 on 110 investigator assessment per RECIST 1.1 . SD must be achieved at ≥ 7 weeks after randomization to be considered best overall response., Disease control rate (DCR) by investigator in HER2 1+/2+/3+ population. Defined as the proportion of patients who have best overall response of CR, PR, or stable disease (SD) by investigator assessment per RECIST 1.1 . SD must be achieved at ≥ 7 weeks after randomization to be considered best overall response., Clinical benefit rate (CBR) by investigator in HER2 2+/3+ population. Defined as the proportion of patients who have best overall response of CR, PR, or stable disease (SD) by investigator assessment per RECIST 1.1 . (duration of SD ≥ 23 weeks after randomization), Clinical benefit rate (CBR) by investigator in HER2 1+/2+/3+ population. Defined as the proportion of patients who have best overall response of CR, PR, or stable disease (SD) by investigator assessment per RECIST 1.1 . (duration of SD ≥ 23 weeks after randomization), Duration of Response Rate (DoR) by investigator in HER2 2+/3+ population. Measured from the time of initial response until documented tumor progression., Duration of Response Rate (DoR) by investigator in HER2 1+/2+/3+ population. Measured from the time of initial response until documented tumor progression., Safety endpoints. Total number of participants in the Safety Analysis Set with any TEAEs, SAEs, AESIs, assessed by CTCAE v5.0 (by investigators) and changes from baseline in vital sings, clinical laboratory results, ECGs, and ECHO/MUGA collected between the first dose and final database lock, Time to first subsequent treatment (TFST) Time to second Subsequent Treatment (TSST) in HER2 2+/3+ population. Defined as the time from the date of randomization to date of the first and second subsequent anticancer therapy or death., Time to first subsequent treatment (TFST) Time to second Subsequent Treatment (TSST) in HER2 1+/2+/3+ population. Defined as the time from the date of randomization to date of the first and second subsequent anticancer therapy or death., Progression free survival 2 (PFS2) measured by investigator in HER2 2+/3+ population. Defined by the time from initial randomization to the second objective disease progression (ie, after the first subsequent therapy) or death., Progression free survival 2 (PFS2) measured by investigator in HER2 1+/2+/3+ population. Defined by the time from initial randomization to the second objective disease progression (ie, after the first subsequent therapy) or death., OS in the HER2 IHC 2+/3+ population. Measured as the time from the date of randomization to the date of death, OS in the HER2 IHC 1+/2+/3+ population. Measured as the time from the date of randomization to the date of death., Response rate of subsequent therapies. Defined as the proportion of patients who have best overall response of either complete response (CR) or partial response (PR), as investigator assessment based on RECIST 1.1.