Brief Summary
Ovarian cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay.
Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 2 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. Approximately 320 participants will be enrolled in the study at 100 sites around the world.
Participants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused Bev alone. The total study duration will be approximately 40 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood teststesting done to measure the levels of certain substances in the blood, and scans.
Intervention / Treatment
- Drug: Mirvetuximab Soravtansine
- Drug: Bevacizumab
- Drug: Carboplatin
Inclusion Criteria
- Substudy 1 and 2: Confirmed high or medium folate receptor alpha (FRa) expression by Ventana folate receptor 1 (FOLR1) Assay.
- Substudy 1 and 2: Participants must have an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group performance status of 0 or 1.
- Substudy 1: Participants must have a confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
- Substudy 1: Tumor must be confirmed HRD test negative (HRP), determined by a local homologous recombination deficient (HRD) test.
- Substudy 2: Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
- Substudy 2: Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells.
- Substudy 2: Participants must have platinum-sensitive disease defined as radiographic progression greater than 6 months from the last dosethe amount of medication taken of platinum-based chemotherapy.
- Substudy 2: Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.