IGYO18058 / Tesaro-FIRST / Richard Moore
Research Question:
Does the drug TSR-042 help the survival of patients with ovarian cancer?
Basic Study Information
Purpose:
Ovarian cancer is a heterogeneous disease, characterized by complex molecular and
genetic changes. The high expression of vascular endothelial growth factor (VEGF)
receptor, programmed death receptor ligands 1 (PD-L1) expression, and deoxyribonucleic
acid (DNA) damage in ovarian tumors provide several targets for treatment and maintenance
of disease response. Given the unmet medical need of participants with advanced or
metastatic ovarian cancer, this study design will enable investigators to provide
participants with current SOC for ovarian cancer for the duration of the study. This
is a global, multicenter, randomized, double-blind, controlled Phase 3 study that
will primarily compare progressive survival rate of PD-L1 positive patients and also
to compare progression-free survival (PFS) of all participants with Stage III or IV
high-grade nonmucinous epithelial ovarian cancer treated with platinum-based combination
therapy, dostarlimab, and niraparib to SOC platinum-based combination therapy. The
currently recommended SOC therapy for the first line treatment of Stage III or IV
ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent
and maintenance bevacizumab. Participants will receive SOC during the chemotherapy
Run-In period (cycle 1) before randomization to study treatment (cycle 2). Concurrent
bevacizumab use must be determined prior to randomization at cycle 2. Approximately
1228 participants will be enrolled into the study and the duration of the study will
be approximately 78 months.
Location: University of Rochester Medical Center
Study Reference #: IGYO18058
Lead Researcher (Principal Investigator)
Lead Researcher:
Richard Moore
Study Contact Information
Study Coordinator: Amber Johnson
Email: amber_johnson@urmc.rochester.edu
Additional Study Details
Trial Not Found
The study you are looking for is not active at this time.
Return to Search