The primary purpose of the study is to evaluate the efficacy of R-DXd with or without bevacizumab as maintenance therapy compared with standard of care (SOC) in participants with platinum-sensitive ovarian cancer (PSOC) as measured by progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR).
Adult participants with assigned female sex at birth.
Participants with histologically or cytologically documented high-grade (Grade 3) serous or endometrioid epithelial ovarian cancer (OVC), primary peritoneal cancer, or fallopian tube cancer.
Has an homologous recombinant deficiency (HRD) or breast cancer gene (BRCA) test result using a validated or approved test as per applicable regulations available.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Non-serous or non-endometrioid high-grade epithelial histology, or non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e., germ cell tumors) or low-grade/borderline OVC.
Major surgery less than (<)28 days.
Radiation therapy less than equal to (≤)28 days (if palliative stereotactic radiation therapy without abdominal radiation, ≤14 days).
Systemic anticancer therapy (including but not limited to antibody-drug therapy, retinoid therapy, and hormonal therapy) <28 days or 5 half-lives, whichever is shorter, before starting trial intervention or current participation in other therapeutic investigational procedures.
Parallel
R-DXd
DrugR-DXd will be administered as an intravenous (IV) infusion.
Bevacizumab
DrugBevacizumab will be administered as an IV infusion.
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
PFS is defined as the time (month) from the date of randomization to the earlier date of the first objective documentation of radiographic disease progression as assessed by BICR per RECIST v1.1 or death due to any cause.
Overall Survival (OS)
OS is defined as the time (month) from the date of randomization to the date of death due to any cause.
PFS as Assessed by Investigator per RECIST v1.1
PFS is defined as the time (month) from the date of randomization to the earlier date of the first objective documentation of radiological disease progression as assessed by the investigator per RECIST v1.1 or death due to any cause.
Progression Free Survival 2 (PFS2)
PFS2 is defined as the time (in months) from the date of randomization to the earlier date of the second disease progression, or death due to any cause.
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
TEAEs are defined as those adverse events (AEs) with a start or worsening date during the on-treatment period (from the first dose date to 70 days after the last dose date of study treatment).
Click on the lead sponsor to view all of their trials.
Daiichi Sankyo
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
