Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers (PICCOLO)

PICCOLO is a Phase 2, multicenter, open label study designed to evaluate the safety and efficacy of MIRV in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression. Mirvetuximab Soravtansine (MIRV) is an investigational drug 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 for the treatment of subjects with recurrent platinum-sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression.

Inclusion Criteria

• Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
• Patients must have a confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer
• Patients must have platinum-sensitive disease defined as radiographic progression greater than 6 months from last dose of most recent platinum therapy Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression

Exclusion Criteria

• Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumor
• Patients with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow
• Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and/or monocular vision

Study Requirements

The study is designed to evaluate the safety and efficacy of Mirvetuximab Soravtansine (MIRV) in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression. Approximately 75 patients will be enrolled. 

All patients will receive single-agent MIRV at 6 mg/kg AIBW administered through IV infusion on Day 1 of every 3-week cycle.

Computerized tomography (CT) or magnetic resonance imaging (MRI) scans will be collected for sensitivity analysis.

Tumor assessments, including radiological assessment by CT/MRI scans, will be performed at Screening and subsequently every 6 weeks (± 1 week) from Cycle 1 Day 1 (C1D1) for the first 36 weeks then every 12 weeks (± 3 weeks) until study participation ends.