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
Trial Information
Current as of July 09, 2025
Recruiting
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.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sarasota, Florida, United States
Edgewood, Kentucky, United States
Pittsburgh, Pennsylvania, United States
Chermside, Queensland, Australia
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported