A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with Mirvetuximab Soravtansine in Subjects with Ovarian Cancer (FLORENZA)

Condition studied

Ovarian Cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

Substudy 1 and 2 and 3: Number of Participants with TEAEs (any grade, Grade ≥ 3), Substudy 1 and 2 nad 3: Number of Participants with TEAEs leading to discontinuation, Substudy 1 and 2 and 3: Number of Participants with Ocular AEs (any grade, Grade ≥ 2), Substudy 1 and 2 and 3: Overall Response (OR) as assessed by the investigator per RECIST v1.1, Substudy 1: Progression free survival (PFS) as assessed by the investigator per RECIST v1.1

Endpoint detail

Substudy 1 and 2 and 3: CA-125 response per Gynecologic Cancer Intergroup (GCIG) Criteria, Substudy 1 and 2 and 3: Duration of Response (DOR) as assessed by the investigator per RECIST v1.1, Substudy 1 and 2 and 3: Number of Participants with Peripheral neuropathy AEs (any grade, Grade ≥ 2), Substudy 1 and 2 and 3: Number of Participants with Pneumonitis/ Interstitial Lung Disease (ILD) (any grade), Substudy 2 and 3: PFS as assessed by the investigator per RECIST v1.1