Study on Mirvetuximab Soravtansine for Treating Advanced Ovarian, Peritoneal, or Fallopian Tube Cancers Resistant to Platinum Therapy
Sponsor: AbbVie
ClinicalTrials ID:NCT06682988
This clinical trial is testing a new drug, Mirvetuximab Soravtansine, to see if it is safe and effective for patients with advanced ovarian, peritoneal, or fallopian tube cancers that have not responded well to platinum-based treatments. The study focuses on cancers with high levels of a protein called folate receptor alpha.
Patient Parameters
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Program Overview
The study aims to evaluate the safety and effectiveness of Mirvetuximab Soravtansine, a new drug designed to target and kill cancer cells in patients with advanced ovarian, peritoneal, or fallopian tube cancers that are resistant to platinum-based treatments. This drug works by attaching to a protein called folate receptor alpha, which is found in high levels on certain cancer cells, and delivering a cell-killing agent directly to them. The study includes two groups: one where participants receive the drug on different schedules, and another to determine the right dose for those with liver issues. About 110 participants will be involved, and the study will last around 24 months. Participants will have regular hospital or clinic visits for check-ups, blood tests, and scans.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- Cancer must be resistant to platinum-based treatments, meaning it returned or progressed after initial treatment.
- Must have had at least one prior line of platinum-based therapy with a response, followed by cancer progression within 3 to 6 months after the last dose.
- Must have cancer progression shown by scans after the most recent treatment.
- Must be in good general health with an ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have at least one tumor that can be measured by scans.
- Tumor must show high levels of folate receptor alpha, as determined by a specific test.
Exclusion Criteria
- Have a type of cancer that is not high-grade serous epithelial, such as endometrioid, clear cell, mucinous, or sarcomatous types, or mixed tumors with these types.
- Have cancer that did not respond to the first platinum-based treatment or progressed within 3 months of the last dose.
- Have a serious illness or active infection that is clinically significant.
- Have had a stroke (bleeding or blockage in the brain) within the last 6 months.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| First Physicians Group /ID# 272180 | 34239 | Sarasota | Florida |
| St. Elizabeth Medical Center - Edgewood /ID# 272113 | 41017 | Edgewood | Kentucky |
| Baptist Health Lexington /ID# 272211 | 40503 | Lexington | Kentucky |
| UMass Memorial Medical Center /ID# 272122 | 01605 | Worcester | Massachusetts |
| Karmanos Cancer Institute - Detroit /ID# 272112 | 48201 | Detroit | Michigan |
| Allegheny Health Network West Penn Hospital /ID# 272267 | 15244 | Pittsburgh | Pennsylvania |
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