OVARIAN: RECURRENT: PLATINUM SENSITIVE: 3rd LINE: FOLATE-RECEPTOR+: GLORIOSA

Study snapshot

Title: ImmunoGen GLORIOSA ovarian folate receptor positive plat sensitive
Malignancy: Ovarian, Fallopian Tube, Primary Peritoneal
Stage: Stage 4
Disease setting: Metastatic/Palliative
Line of therapy: 3rd Line
Investigational agent: Mirvetuximab soravtansine plus bevacizumab
Drug class: Ab drug conjugate against folate receptor alpha + VEG-F inhibitor
Principal investigator: Todd Tillmanns, MD
Sponsor: Immunogen, Inc.
Path: High grade serous ovarian/primary peritoneal/fallopean tube cancer
Randomized: Yes
ClinicalTrials.gov ID: NCT05445778

ECOG PS 0-1
Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
If patients are BRCA positive, must have received treatment with PARP inhibitors
Must be folate receptor alpha positive as defined by FRa positivity of >75% of tumor membrane staining at 2+ intensity or higher.
Disease must have relapsed after 1 line of platinum-based therapy and must be platinum-sensitive defined as progression greater than 6 months from last dose of primary platinum therapy
Must be appropriate for, currently be on, or have completed platinum-based triplet therapy in the second line. Must have received no less than 4 and no greater than 8 cycles in the second line
Must have receirved, be currently be receiving, or be planned to receive paclitaxel, gemcitabine, pegylated lipsomal doxorubicin as the partner drug to platinum based therapy
After completion of platinum based triple therapy and before randomization, patient must have achieved a CR, pR, or SD
Before randomization must have either a) measurable disease, b) persistently elevated CA-125 or c) no evidence of disease and normalization of CA-125
No endometrioid, clear cell, mucinous, or sarcomatous histology
No more than 1 line of prior chemotherapy before planned triplet therapy
No PD while on triple therapy
No cirrhotic liver disease
No severe cardiac disease
No history of bowel obstruction, abdominal fistula, or GI perforation
No folate deficiency
No other malignancy within 3 years