A randomized Phase 2, open-label study of mirvetuximab soravtansine in patients with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression testing 2 schedules of administration for dose optimization, with a separate cohort to determine starting dose in patients with moderate hepatic impairment

Objective:

Randomized Phase 2 Cohort

Primary Objectives:

• To characterize the safety of the alternative dosing schedule and the US-approved dosing schedule
• To evaluate efficacy parameters of the alternative dosing schedule and the US-approved dosing schedule

Secondary Objectives:

• To investigate the frequency of ocular disorders, peripheral neuropathy, infusion reactions, and pneumonitis with 2 schedules of administration of MIRV
• To investigate the safety profiles of 2 schedules of administration of MIRV
• To evaluate additional measures of clinical efficacy with 2 schedules of administration of MIRV
• To characterize the PK of MIRV in the alternative dosing schedule, compare PK with the US-approved dosing schedule, and reassess the existing ER models
• To assess doses based on body surface area (BSA) that are equivalent to doses based on AIBW

Hepatic Impairment Cohort

Primary Objectives:

• To determine the starting dose of MIRV in patients with moderate hepatic impairment

Secondary Objectives:

• To determine the safety profile of MIRV in patients with moderate hepatic impairment