This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) in combination with bevacizumab works in treating platinum-sensitive ovarian cancer compared to standard treatments by checking whether it makes cancers smaller or disappear completely and if it helps participants live longer. The study also assesses whether Mo-Rez in combination with bevacizumab is safe and tolerated well by participants compared to standard treatments and aims to provide a better understanding of the main side effects of Mo-Rez.
Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed Consent Form (ICF).
Has epithelial ovarian, primary peritoneal, or fallopian-tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid, clear cell carcinoma, or carcinosarcoma.
Adjuvant ± neoadjuvant is considered one line of therapy.
Maintenance therapy (e.g., bevacizumab, Poly ADP-ribose polymerase inhibitor [PARPi]) will be considered as part of the preceding line of therapy (i.e., not counted independently).
Plans to undergo interval secondary cytoreductive surgery for recurrent PSOC during induction therapy (platinum doublet and bevacizumab).
Has a malignancy (except disease under study) that has progressed or required active treatment within the past 36 months prior to the date of randomization, except for basal cell or squamous cell carcinomas of the skin or in situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease, or that is otherwise considered cured by the investigator.
Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Has untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases). Participants with previously treated and clinically stable brain/CNS metastases and who have completed all corticosteroid therapy for ≥14 days prior to the date of C1D1 are not excluded from participation.
Parallel
Mocertatug rezetecan (Mo-Rez)
DrugMocertatug rezetecan will be administered
Carboplatin
DrugCarboplatin will be administered
Paclitaxel
DrugPaclitaxel will be administered
Gemcitabine
DrugGemcitabine will be administered
Pegylated liposomal doxorubicin (PLD)
DrugPLD will be administered
Bevacizumab
DrugBevacizumab will be administered
Progression Free Survival (PFS) by BICR
PFS is defined as the time from the date of randomization to the date of first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first.
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
PFS by investigator assessment
PFS is 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.
Time to Second Progression (PFS2)
PFS2 is defined as the time from the date of randomization to the date of first documented investigator-assessed clinical or radiographical progression following the first subsequent anticancer therapy and after the progression event used for the primary variable PFS, or death from any cause, whichever occurs first.
Objective response rate (ORR) by investigator assessment
ORR is defined as the percentage of participants with a complete response (CR) or partial response (PR) per RECIST 1.1 by investigator assessment.
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GlaxoSmithKline
Lead sponsor
GOG, ENGOT, APGOT
Collaborator
