Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients must have confirmation of FRα positivity by the Ventana FOLR1 Assay.
Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer (GLORIOSA)
IMGN857-0421, Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab (GLORIOSA)
Fallopian tube cancer, Ovarian cancer, Peritoneal cancer
All genders
18+
Recruiting now
Overview
Principal Investigator: Sarah Paraghamian, MD
Contact Us
Latoya Lashley
Study details
Inclusion Criteria
- 1. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 2. Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
- 3. Patients must be willing to provide an archival tumor tissue block or slides, or must undergo a procedure to obtain a new biopsy using a low-risk, medically routine procedure for IHC confirmation of high FRα expression (reported as "positive") as defined by the Ventana FOLR1 Assay. Patients must be confirmed FRα-high as defined by FRα positivity of ≥ 75% of tumor membrane staining at ≥ 2+ intensity (PS2+) for entry into the study.
Exclusion Criteria
- 1. Patients with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor
- 2. More than one line of prior chemotherapy before current/planned triplet therapy.
- 3. Patients with PD while on or following platinum-based triplet therapy
Study Requirements
Patients randomized to MIRV plus bevacizumab as maintenance (Arm 1) will receive MIRV plus bevacizumab every 3 weeks until disease progression or unacceptable toxicity. Experimental Arm 1: Mirvetuximab Soravtansine (MIRV) plus Bevacizumab - Participants will receive MIRV plus Bevacizumab every 3 weeks. Patients randomized to single-agent bevacizumab as maintenance (Arm 2) will receive bevacizumab Q3W until disease progression or unacceptable toxicity. The study will enroll patients whose tumor samples are FRα-high. All patients must have had prior germline or somatic tumor breast cancer susceptibility gene (BRCA) testing or be tested at study entry. All patients will have received a minimum of 4 cycles and a maximum of 8 cycles of a standard platinum-based triplet therapy to include at least 3 cycles of bevacizumab. Tumor assessments, including radiological assessments by CT/MRI scans, will be performed in both groups within 3 to 8 weeks of completion of triplet therapy and before randomization to evaluate response to triplet therapy. Starting on Cycle 1 Day 1 of maintenance therapy, subsequent radiological assessments will be conducted every 9 weeks for 72 weeks, and subsequently every 18 weeks. In addition, after discontinuation of maintenance treatment, all patients will be followed for survival every 4 months.