Molecular details
Biomarker: FRalfa pos
Biomarker criteria: Mandatory
Prescreening: Local
Additional study population requirements: Inclusion criteria:
Prior BRCA testing on the tumor or prior germline testing is required for eligibility. If not done prior, tumor or germline testing will need to be done at study entry. Somatic and germline BRCA-positive patients must have received prior treatment with a PARPi.
Patients must provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRa positivity; FRa-expressing tumors will be defined and classified by the Ventana FOLR1 Assay into low, medium, and high expressions defined as 25%-49%, 50%-74%, and = 75% of tumor cells with PS2+ staining intensity, respectively. Patients must have confirmation of FRa positivity of = 25% of tumor staining at = 2+ intensity for entry into the study.
