A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

Exclusion Criteria

• •4. Participants must have progressed radiographically on or after their most recent line of anticancer therapy.
• •5. Participants 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 Folate Receptor α (FRα) positivity
• •6. Participant's tumor must be positive for FRα expression as defined by the Ventana FOLR1 Assay
• •7. Participants must have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator)
• •8. Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, including at least 1 line of therapy containing bevacizumab, and for whom single-agent therapy is appropriate as the next line of treatment:
• •1. Adjuvant ± neoadjuvant considered 1 line of therapy
• •2. Maintenance therapy (e.g., bevacizumab, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors) will be considered part of the preceding line of therapy (i.e., not counted independently)
• •3. Therapy changed due to toxicity in the absence of progression will be considered part of the same line (i.e., not counted independently)
• •4. Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
• •9. Participants must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
• •10. Participants must have completed prior therapy within the specified times below:
• •1. Systemic antineoplastic therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to first dose of MIRV
• •2. Focal radiation completed at least 2 weeks prior to first dose of MIRV
• •11. Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia)
• •12. Participants must have completed any major surgery at least 4 weeks prior to first dose of MIRV and have recovered or stabilized from the side effects of prior surgery
• •13. Participants must have adequate hematologic, liver and kidney functions defined as:
• •1. Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (1,500/μL) without G-CSF in the prior 10 days or long-acting WBC growth factors in the prior 20 days
• •2. Platelet count ≥ 100 x 10\^9/L (100,000/μL) without platelet transfusion in the prior 10 days
• •3. Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 21 days
• •4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
• •5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
• •1. Male participants
• •2. Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumor
• •3. Participants with primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum-containing chemotherapy
• •4. Participants with prior wide-field radiotherapy (RT) affecting at least 20 percent of the bone marrow
• •5. Participants with \> Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
• •6. 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, and /or monocular vision
• •7. Participants with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
• •1. Active hepatitis B or C infection (whether or not on active antiviral therapy)
• •2. Human immunodeficiency virus (HIV) infection
• •3. Active cytomegalovirus infection
• •4. Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV
• •Note: Testing at screening is not required for the above infections unless clinically indicated
• •8. Participants with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
• •9. 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
• •10. Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
• •11. Participants with a history of cirrhotic liver disease (Child-Pugh Class B or C)
• •12. Participants with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis
• •13. Participants requiring use of folate-containing supplements (eg, folate deficiency)
• •14. Participants with prior hypersensitivity to monoclonal antibodies (mAb)
• •15. Women who are pregnant or breastfeeding
• •16. Participants who received prior treatment with MIRV or other FRα-targeting agents
• •17. Participants with untreated or symptomatic central nervous system (CNS) metastases
• •18. Participants with a history of other malignancy within 3 years prior to 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
• •19. Prior known hypersensitivity reactions to study drugs and/or any of their excipients