Study on Mirvetuximab Soravtansine with Carboplatin for Second-line Treatment of Folate Receptor Alpha Positive, Platinum-sensitive Ovarian Cancer
Sponsor: AbbVie
ClinicalTrials ID:NCT05456685
This clinical trial is testing a combination of the drugs Mirvetuximab Soravtansine and Carboplatin to treat ovarian cancer that has returned after initial treatment and is sensitive to platinum-based chemotherapy. The study focuses on patients whose cancer cells have a specific marker called folate receptor alpha.
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Program Overview
This study is exploring the effectiveness and safety of using Mirvetuximab Soravtansine (MIRV) together with Carboplatin in treating ovarian cancer that has come back after one round of platinum-based chemotherapy and is sensitive to it. The trial is for patients whose cancer cells show a marker called folate receptor alpha (FRα). After completing six cycles of the combination treatment, patients whose cancer has not progressed will continue with just MIRV. To participate, patients must have their cancer tested to confirm it has the FRα marker.
Description
This Phase 2 study is designed to evaluate how well the drug Mirvetuximab Soravtansine (MIRV) works when combined with Carboplatin in treating ovarian cancer that has returned after initial treatment and is sensitive to platinum-based chemotherapy. The study focuses on patients whose cancer cells have a specific marker called folate receptor alpha (FRα). Participants will first receive a combination of MIRV and Carboplatin for six cycles. If the cancer does not progress, they will continue with MIRV alone. To join the study, patients must have their cancer tested to confirm it has the FRα marker. The study aims to determine if this treatment approach can effectively manage the cancer while monitoring for any side effects.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
- Must have cancer that has returned after one round of platinum-based chemotherapy.
- Cancer must be platinum-sensitive, meaning it has not progressed for more than six months after the last platinum treatment.
- If available, BRCA gene testing is required, and those with BRCA mutations must have tried a specific type of treatment unless it's not suitable for them.
- Must have at least one measurable tumor.
- Must provide a tumor sample to confirm the presence of the FRα marker.
- Must have recovered from any previous treatments and surgeries.
- Must have adequate blood, liver, and kidney function.
- Must agree to use effective birth control during the study and for a specified time after treatment.
- Must have a negative pregnancy test before starting treatment.
Exclusion Criteria
- Cannot have certain types of ovarian cancer or more than one previous chemotherapy treatment.
- Cannot have had extensive radiation therapy affecting the bone marrow.
- Cannot have severe nerve damage or certain eye conditions.
- Cannot have serious illnesses or infections, including active hepatitis or HIV.
- Cannot have a history of certain neurological or heart conditions.
- Cannot have had a stroke or severe liver disease recently.
- Cannot be taking folate supplements.
- Cannot have had allergic reactions to similar drugs.
- Cannot be pregnant or breastfeeding.
- Cannot have had previous treatment with MIRV or similar drugs.
- Cannot have untreated or symptomatic brain metastases.
- Cannot have had another cancer within the last three years, except for certain low-risk cancers.
- Cannot have known allergies to the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Arizona Cancer Center /ID# 268906 | 85704 | Tucson | Arizona |
| Women'S Cancer Research Network - Cogi /ID# 268912 | 93710 | Fresno | California |
| Providence - St. Jude Medical /ID# 268911 | 92835-3826 | Fullerton | California |
| Moores Cancer Center /ID# 268888 | 92037 | La Jolla | California |
| USC Norris Comprehensive Cancer Center /ID# 268964 | 90033 | Los Angeles | California |
| University of California Los Angeles Medical Center /ID# 268883 | 90095 | Los Angeles | California |
| Hoag Memorial Hospital Presbyterian /ID# 268907 | 92663 | Newport Beach | California |
| UC Davis Comprehensive Cancer Center /ID# 269085 | 95817 | Sacramento | California |
| Scripps Md Anderson - Prebys Cancer Center /ID# 268966 | 92103 | San Diego | California |
| California Pacific Medical Center - Van Ness Campus /ID# 268886 | 94109 | San Francisco | California |
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