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

Inclusion Criteria:

1. Must be ≥ 18 years of age.

2. Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.

3. Must have a confirmed diagnosis of high-grade serous epithelial ovarian, primaryperitoneal, or fallopian tube cancer.

4. Must have relapsed after 1 prior line of platinum-based chemotherapy.

5. Must have platinum-sensitive disease defined as radiographic progression greaterthan 6 months from last dose of platinum-based chemotherapy. Note: Progressionshould be calculated from the date of the last administered dose of platinum therapyto the date of the radiographic imaging showing progression.

6. If available locally and is the standard of care, breast cancer susceptibility gene (BRCA) testing on the tumor or prior germline testing is required for eligibility,and will need to be done prior to study entry. Somatic and germline BRCA-positiveparticipants must have received prior treatment with a poly adenosinephosphate-ribose polymerase inhibitor (PARPi) unless documented as clinicallycontraindicated.

7. Must have at least 1 lesion that meets the definition of measurable disease byRECIST v1.1 (radiologically measured by the investigator).

8. Must provide an archival tumor tissue block or slides, or undergo procedure toobtain a new biopsy using a low-risk, medically routine procedure forimmunohistochemistry (IHC) confirmation of FRα positivity; FRα-expressing tumorswill be defined and classified by the Ventana FOLR1 Assay into low, medium, and highexpressions defined as 25%-49%, 50%-74%, and ≥ 75% of tumor cells with PS2+ stainingintensity, respectively. Must have confirmation of FRα positivity of ≥ 25% of tumorstaining at ≥ 2+ intensity for entry into the study.

9. Must have stabilized or recovered (Grade 1 or baseline) from all priortherapy-related toxicities (except alopecia) and have discontinued any maintenancetherapy at least 4 weeks before the first dose of carboplatin plus MIRV.

10. Must have completed any major surgery at least 4 weeks before the first dose ofcarboplatin plus MIRV and have recovered or stabilized from the side effects ofprior surgery before the first dose of carboplatin plus MIRV.

11. Must have adequate hematologic, liver, and kidney functions defined as:

12. Absolute neutrophil count ≥ 1.5 × 10^9/ liter(L) (1500/ microliter [μL])without granulocyte colony-stimulating factor or long-acting white blood cellgrowth factors in the 10 days prior to the Cycle 1 Day 1 (C1D1) dose

13. Platelet count ≥ 100 × 109/L (100,000/μL) without platelet transfusion in the 10 days prior to the C1D1 dose

14. Hemoglobin ≥ 9.0 grams/deciliter (g/dL) without packed red blood celltransfusion in the 14 days prior to the C1D1 dose

15. Serum creatinine ≤ 1.5 × upper limit of normal (ULN)

16. Aspartate aminotransferase and alanine aminotransferase ≤ 3.0 × ULN

17. Serum bilirubin ≤ 1.5 × ULN (participants with documented diagnosis of Gilbertsyndrome are eligible if total bilirubin < 3.0 × ULN)

18. Serum albumin ≥ 2 g/dL

19. Must be willing and able to sign the informed consent form (ICF) and to adhere tothe protocol requirements.

20. Females of childbearing potential (FCBP) must agree to use highly effectivecontraceptive method(s) while on study medication and for at least 3 months afterthe last dose of MIRV and 6 months after the last dose of carboplatin.

21. FCBP must have a negative pregnancy test within the 4 days prior to the C1D1 dose.

Exclusion Criteria:

1. Participants with endometrioid, clear cell, mucinous, or sarcomatous histology,mixed tumors containing any of the above types, or low-grade/ borderline ovariantumor

2. More than one line of prior chemotherapy. Lines of prior anticancer therapy arecounted with the following considerations:

3. Neoadjuvant ± adjuvant therapies are considered 1 line of therapy if theneoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise,they are counted as 2 prior regimens.

4. Maintenance therapy (eg, bevacizumab, PARPi) will be considered part of thepreceding line of therapy (ie, not counted independently).

5. Participants with prior wide-field radiotherapy affecting at least 20% of the bonemarrow

6. Participants with > Grade 1 peripheral neuropathy per Common Terminology Criteriafor Adverse Events (CTCAE)

7. Participants with active or chronic corneal disorders, history of cornealtransplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degenerationrequiring intravitreal injections, active diabetic retinopathy with macular edema,macular degeneration, presence of papilledema, or monocular vision

8. Participants with serious concurrent illness or clinically relevant activeinfection, including, but not limited to the following:

9. Active hepatitis B virus (HBV) or hepatitis C virus (HCV)or C infection (whether or not on active antiviral therapy)

10. HIV infection if inclusion clarifying eligibility for HIV positive participantsis not met

11. Active cytomegalovirus infection

12. Any other concurrent infectious disease requiring IV antibiotics within 2 weeksprior to the first dose of carboplatin plus MIRV Note: Testing at screening isnot required for the above infections unless clinically indicated.

13. Participants with a history of multiple sclerosis or other demyelinating diseaseand/or Lambert-Eaton syndrome (paraneoplastic syndrome)

14. Participants with clinically significant cardiac disease including, but not limitedto, any of the following:

15. Myocardial infarction ≤ 6 months prior to first dose

16. Unstable angina pectoris

17. Uncontrolled congestive heart failure (New York Heart Association > class II)

18. Uncontrolled ≥ Grade 3 hypertension (per CTCAE)

19. Uncontrolled cardiac arrhythmias

20. Participants with a history of hemorrhagic or ischemic stroke within 6 months priorto enrollment

21. Participants with a history of cirrhotic liver disease (Child-Pugh Class B or C)

22. Participants with a previous clinical diagnosis of noninfectious interstitial lungdisease, including noninfectious pneumonitis (exception: Grade 1 noninfectiouspneumonitis diagnosed on or within 6 weeks after treatment with an immunotherapeuticagent used in the treatment of their malignancy that has resolved per investigatoror resolution of the radiologic findings)

23. Participants requiring use of folate-containing supplements (eg, folate deficiency)

24. Participants with prior hypersensitivity to monoclonal antibodies (mAb)

25. Females who are pregnant or breastfeeding

26. Participants who received prior treatment with MIRV or other FRαtargeting agents

27. Participants with untreated or symptomatic central nervous system metastases

28. Participants with a history of other malignancy within 3 years before enrollmentNote: 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.

29. Prior known hypersensitivity reactions or known contraindications to study drugs orany of their excipients