This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) alone or in combination with bevacizumab works in treating ovarian cancer compared to bevacizumab alone or active observation (AO). The study also assesses whether Mo-Rez is safe and tolerated well by participants in comparison to bevacizumab alone OR AO and will help provide a better understanding of the main side effects of the drugs.
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 newly diagnosed Stage III/IV (2014 FIGO staging) [Berek, 2021] epithelial ovarian, primary peritoneal or fallopian tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid, clear cell carcinoma, carcinosarcoma or mixed histology.
Has completed first-line platinum-based chemotherapy cycles. Inclusion of IV regimens at Q3W cycles, consolidation regimens and Intravenous (IV)/ Intraperitoneal (IP) and Hyperthermic intraperitoneal chemotherapy (HIPEC) regimens are acceptable. In the event of history of platinum or paclitaxel allergy, alternative agents are allowed (in consultation with the sponsor). At least cycles of first-line chemotherapy must be completed with or without bevacizumab.
Has Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) response determined by investigator after the completion of first-line treatment must be Complete response (CR), Partial response (PR), No evidence of disease (NED), or Stable disease (SD).
Has Ovarian cancer (OC) with germline or somatic pathogenic/likely pathogenic Breast cancer gene (BRCA)1/2 mutation or evidence of homologous repair deficiency as per local or central test.
Has a malignancy (except disease under study) that has progressed or required active treatment within the past 36 months prior to 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.
First-line Poly adenosine diphosphate-ribosylation (ADP) ribose polymerase inhibitor(s) (PARPi) for maintenance is a treatment option for participants, as determined by the Principal Investigator.
Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
Parallel
Mocertatug rezetecan
DrugMocertatug rezetecan will be administered
Bevacizumab
DrugBevacizumab will be administered
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of first documented Progressive Disease (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 Progressive disease (PD) per RECIST 1.1 by investigator or death from any cause, whichever occurs first
Time to first subsequent therapy (TFST)
TFST is 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
Time to second subsequent therapy (TSST)
TSST is 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
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GlaxoSmithKline
Lead sponsor
ENGOT, GOG, APGOT
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
