Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer

Exclusion Criteria

• •1. Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above types, or low-grade/ borderline ovarian tumor
• •2. More than one line of prior chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:
• •1. Neoadjuvant ± adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.
• •2. Maintenance therapy (eg, bevacizumab, PARPi) will be considered part of the preceding line of therapy (ie, not counted independently).
• •3. Participants with prior wide-field radiotherapy affecting at least 20% of the bone marrow
• •4. Participants with \> Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
• •5. Participants 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, or monocular vision
• •6. Participants with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
• •1. Active hepatitis B virus (HBV) or hepatitis C virus (HCV)or C infection (whether or not on active antiviral therapy)
• •2. HIV infection if inclusion clarifying eligibility for HIV positive participants is not met
• •3. Active cytomegalovirus infection
• •4. Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of carboplatin plus MIRV Note: Testing at screening is not required for the above infections unless clinically indicated.
• •7. Participants with a history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
• •8. Participants with clinically significant cardiac disease including, but not limited to, any of the following:
• •1. Myocardial infarction ≤ 6 months prior to first dose
• •2. Unstable angina pectoris
• •3. Uncontrolled congestive heart failure (New York Heart Association \> class II)
• •4. Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
• •5. Uncontrolled cardiac arrhythmias
• •9. Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
• •10. Participants with a history of cirrhotic liver disease (Child-Pugh Class B or C)
• •11. Participants with a previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis (exception: Grade 1 noninfectious pneumonitis diagnosed on or within 6 weeks after treatment with an immunotherapeutic agent used in the treatment of their malignancy that has resolved per investigator or resolution of the radiologic findings)
• •12. Participants requiring use of folate-containing supplements (eg, folate deficiency)
• •13. Participants with prior hypersensitivity to monoclonal antibodies (mAb)
• •14. Females who are pregnant or breastfeeding
• •15. Participants who received prior treatment with MIRV or other FRαtargeting agents
• •16. Participants with untreated or symptomatic central nervous system metastases
• •17. Participants with a history of other malignancy within 3 years before enrollment Note: Participants 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.
• •18. Prior known hypersensitivity reactions or known contraindications to study drugs or any of their excipients