A Randomized, Open-Label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan with Bevacizumab Compared with Platinum Doublet with Bevacizumab in Participants with Platinum-Sensitive Ovarian Cancer

Condition studied

Ovarian Neoplasms

Investigational medicinal product(s)

Every trial of Doxorubicin, Gemcitabine, Paclitaxel and Bevacizumab across our registers →

Eligibility

Primary endpoint

PFS, defined as the time from the date of randomization to the date of first documented PD per RECIST 1.1 by BICR or death from any cause, whichever occurs first

Endpoint detail

OS, defined as the time from the date of randomization to the date of death due to any cause, PFS, defined as the time from the date of randomization to the date of first documented PD per RECIST 1.1 by investigator assessment or death from any cause, whichever occurs first, PFS2, defined as the time from the date of randomization to the date of documented investigator assessed clinical or radiological progression following first subsequent anticancer therapy and after the progression event used for the primary variable PFS, or death from any cause, whichever occurs first, ORR, defined as the percentage of participants with a CR or PR per RECIST 1.1 by investigator assessment, DoR, defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by investigator assessment to the date of first documented PD per RECIST 1.1 by investigator assessment or death from any cause, whichever occurs first, ORR, defined as the percentage of participants with a CR or PR per RECIST 1.1 by BICR, DoR, defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by BICR assessment to the date of first documented PD per RECIST 1.1 by BICR assessment or death from any cause, whichever occurs first, TFST, defined as the time from the date of randomization to the date of initiation of subsequent therapy or death from any cause, whichever occurs first, TSST, defined as the time from the date of randomization to the date of initiation of second subsequent therapy or death from any cause, whichever occurs first, Incidence of TEAEs, AESIs, TESAEs Incidence of TEAEs leading to dose modifications (e.g., dose delay) or study intervention discontinuation Changes in vital signs, laboratory tests (hematology and clinical chemistry), and ECG, Change from baseline in global health status/QOL, physical functioning, role functioning domains as assessed by the EORTC QLQ-C30, Change from baseline in abdominal/gastrointestinal symptoms as assessed by the EORTC QLQ-OV28, TTD defined as the time from the date of randomization to the date of the first confirmed clinically meaningful deterioration on any of the following domains of the EORTC QLQC30: Global Health Status/QOL, Physical Functioning and Role Functioning domains of the EORTC QLQ-C30, TTD defined as the time from the date of randomization to the date of the first confirmed clinically meaningful deterioration on the abdominal/GI symptom domain of the EORTC QLQ-OV28, PK concentration of Mo-Rez, Incidence of ADA and nAb and summary of ADA titers