A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine

Launched by ABBVIE · Nov 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Mirvetuximab Soravtansine (MIRV) for women with advanced high-grade ovarian, primary peritoneal, or fallopian tube cancers that have not responded to standard platinum-based chemotherapy (this is known as platinum-resistant cancer). The treatment works by specifically targeting cancer cells that have a protein called folate receptor alpha (FRα), delivering a drug directly to these cells to help kill them. The study will include about 110 participants, and they will be divided into two groups to receive MIRV on different schedules.

To be eligible for this trial, participants need to have a confirmed diagnosis of high-grade serous epithelial ovarian cancer or similar types, and their tumors must show a high level of FRα. Participants should have had at least one previous platinum-based treatment and experienced disease progression after that. During the study, participants will need to visit the hospital or clinic regularly for assessments, blood tests, and scans to monitor their health and response to the treatment. This trial may involve more visits and tests than standard care, but it aims to provide new options for women facing challenging cancer situations.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Both Cohorts
• • Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
• * Participants with platinum-resistant disease:
• • Participants with 1 prior line of platinum-based therapy who have received ≥ 4 cycles of platinum and had a response (complete response (CR) or partial response (PR)) followed by radiological progressive disease (PD) between \> 3 months and ≤ 6 months after the date of the last dose of platinum.
• • Participants with 2 or 3 prior lines of platinum-based therapy who had radiological PD
• • 6 months after the date of the last dose of platinum.
• • Participants with progression diagnosed radiographically on or after their most recent line of therapy.
• • Participants with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• • Participants with ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).
• • Participants with a tumor that is positive for folate receptor alpha (FRα) expression as determined by the Ventana folate receptor 1 (FOLR1) assay (≥ 75% of tumor staining at 2+ intensity).
• Exclusion Criteria:
• • Both Cohorts
• • Participants with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or borderline ovarian tumor.
• • Participants with primary platinum-refractory disease, defined as disease that did not respond (complete response (CR) or partial response (PR)) or that progressed radiographically within 3 months of the last dose of first-line platinum-containing chemotherapy.
• • Participants with serious concurrent illness or clinically relevant active infection as outlined in the protocol
• • Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to randomization.