Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Prior treatment

• Patients who have previously been treated with a systemic anti-cancer therapy
• Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
• Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV
• Myocardial infarction ≤ 6 months prior to first dose
• Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
• Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis
• Patients with prior hypersensitivity to monoclonal antibodies (mAb)
• Patients who received prior treatment with MIRV or other FRα-targeting agents

Other illness

• History of hepatitis B or C infection (whether or not on active antiviral therapy)
• History of human immunodeficiency virus (HIV) infection
• Patients with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
• Patients with clinically significant cardiac disease including, but not limited to, any of the following:
• Unstable angina pectoris
• Uncontrolled congestive heart failure (New York Heart Association \> class II)
• Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
• Uncontrolled cardiac arrhythmias
• Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
• Patients with a history of other malignancy within 3 years prior to enrollment Note: patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible

Age

• 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

Other

• Patients with low-grade serous, endometrioid, clear cell, or mucinous histology
• Patients requiring use of folate-containing supplements (eg, folate deficiency)
• Women who are pregnant or breastfeeding
• Patients with untreated or symptomatic central nervous system (CNS) metastases

• Patients must have biopsy-confirmed high grade serous epithelial ovarian cancer.
• Patients must present with stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy
• Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity
• Patients must have a performance status of 0 or 1.
• Patient's tumor must be positive for FRα expression as defined by a score of PS2+ intensity in \>75% of cells
• Patients must have adequate hematologic, liver and kidney functions defined as:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1,500/μL)
• Platelet count ≥ 100 x 109/L (100,000/μL) without platelet transfusion in the prior 10 days
• Hemoglobin ≥ 9.0 g/dL
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
• Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 x ULN)
• Serum albumin ≥ 2 g/dL
• Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements
• Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) (as defined in Section 5.8.6 while on MIRV and for at least 4 months after the last dose
• WCBP must have a negative pregnancy test within the 4 days prior to the first dose of MIRV