Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy for Folate Receptor Alpha Positive Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Inclusion Criteria

• Patients must have biopsy-confirmed epithelial ovarian cancer prior to treatment with mirvetuximab soravtansine (MIRV). * Note: Patients may sign consent prior to a histologic diagnosis in order to obtain tissue for folate receptor alpha (FRalpha) testing as long as there is a reasonable suspicion for advanced ovarian cancer by the treating oncologist (i.e., radiographic evidence of carcinomatosis, omental caking, or pleural effusions; CA-125/ carcinoembryonic antigen [CEA] ratio >= 25; and/or malignant ascites).
• Patients must present with stage III or IV disease and be eligible 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 FRalpha positivity.
• Patients must have a performance status of 0, 1, or 2.
• Patient’s tumor must be positive for FRalpha expression as defined by a score of 2+ in 75% of cells.
• Absolute neutrophil count (ANC) >= 1.5 x 10 ^ 9/L (1,500/uL).
• Platelet count >= 100 x 10 ^ 9/L (100,000/uL) 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 or their legally authorized representative 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 have a negative pregnancy test within 4 days prior to the first dose of carboplatin and must agree to immediately begin using highly effective contraceptive method(s) until at least 6 months after the last dose of the study drugs.

Exclusion Criteria

• Patients who have previously been treated with a systemic anti-cancer therapy.
• Patients with low-grade serous, endometrioid, clear cell, or mucinous histology.
• 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.
• Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following: * History of hepatitis B or C infection (whether or not on active antiviral therapy) * History of human immunodeficiency virus (HIV) infection * Any other concurrent infectious disease requiring intravenous (IV) antibiotics within 2 weeks prior to the first dose of MIRV.
• 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: * Myocardial infarction =< 6 months prior to first dose * Unstable angina pectoris * Uncontrolled congestive heart failure (New York Heart Association > class II) * Uncontrolled >= grade 3 hypertension (per Common Terminology Criteria for Adverse Events [CTCAE]) * Uncontrolled cardiac arrhythmias.
• Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment.
• Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C).
• Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis.
• Patients requiring use of folate-containing supplements (eg, folate deficiency).
• Patients with prior hypersensitivity to monoclonal antibodies (mAb).
• Women who are pregnant or breastfeeding.
• Patients who received prior treatment with MIRV or other FRalpha-targeting agents.
• Patients with untreated or symptomatic central nervous system (CNS) metastases.
• 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.