Summary

IMGN853-0420 is a multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab
soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha
positive, recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or
fallopian tube cancer following 1 prior line of platinum-based chemotherapy.

Objectives

This Phase 2 study is designed to evaluate the efficacy and safety of MIRV in combination
with carboplatin followed by MIRV continuation in FRa-positive patients with recurrent
platinum-sensitive ovarian cancer (PSOC) following 1 prior line of platinum-based
chemotherapy. Upon completion of carboplatin plus MIRV combination chemotherapy (6 cycles),
patients without progressive disease will continue on single-agent MIRV. Patients must have
confirmation of FRa positivity by the Ventana FOLR1 Assay.

Eligibility

1. Patients must be = 18 years of age.
2. Patients must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
3. Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
4. Patients must have relapsed after 1 prior line of platinum-based chemotherapy.
5. Patients must have platinum-sensitive disease defined as radiographic progression greater than 6 months from last dose of platinum-based chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.
6. Prior BRCA testing on the tumor or prior germline testing is required for eligibility. If not done prior, tumor or germline testing will need to be done at study entry. Somatic and germline BRCA-positive patients must have received prior treatment with a PARPi.
7. Patients must have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).
8. Patients must 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 FRa positivity; FRa-expressing tumors will be defined and classified by the Ventana FOLR1 Assay into low, medium, and high expressions defined as 25%-49%, 50%-74%, and = 75% of tumor cells with PS2+ staining intensity, respectively. Patients must have confirmation of FRa positivity of = 25% of tumor staining at = 2+ intensity for entry into the study.
9. Patients must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia) and have discontinued any maintenance therapy at least 4 weeks before the first dose of carboplatin plus MIRV.
10. Patients must have completed any major surgery at least 4 weeks before the first dose of carboplatin plus MIRV and have recovered or stabilized from the side effects of prior surgery before the first dose of carboplatin plus MIRV.
11. Patients must have adequate hematologic, liver, and kidney functions defined as:
12. Absolute neutrophil count = 1.5 × 109/L (1500/µL) without granulocyte colony-stimulating factor or long-acting white blood cell growth factors in the 10 days prior to the 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 g/dL without packed red blood cell transfusion in the 14 days prior to the C1D1 dose
15. Serum creatinine = 1.5 × ULN
16. Aspartate aminotransferase and alanine aminotransferase = 3.0 × ULN
17. Serum bilirubin = 1.5 × ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 × ULN)
18. Serum albumin = 2 g/dL
19. Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements.
20. Females of childbearing potential (FCBP) must agree to use highly effective contraceptive method(s) while on study medication and for at least 3 months after the 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.

Treatment Sites in Georgia