Study on the Effectiveness of Carboplatin and Mirvetuximab Soravtansine for Advanced Ovarian, Fallopian Tube, or Peritoneal Cancer
Sponsor: AbbVie
ClinicalTrials ID:NCT06890338
This clinical trial is testing a new treatment combining carboplatin and mirvetuximab soravtansine to see if it can safely and effectively treat advanced-stage ovarian, fallopian tube, or peritoneal cancer that expresses a specific protein called folate receptor alpha (FRα).
Patient Parameters
| Parameter | Options |
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Program Overview
This study aims to evaluate the safety and effectiveness of a new treatment using carboplatin and mirvetuximab soravtansine for patients with advanced-stage ovarian, fallopian tube, or peritoneal cancer that shows the folate receptor alpha (FRα) protein. Mirvetuximab Soravtansine is an experimental drug designed to target and kill cancer cells by delivering a cell-killing agent directly to them. The study will involve about 140 participants across 80 sites in the U.S. Participants will receive the treatment through an IV every 21 days for up to 6 to 9 cycles, with the study lasting around 3 years. Participants may need to visit the hospital or clinic regularly for check-ups, blood tests, and scans.
Eligibility Criteria
Inclusion Criteria
- Must have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must be considered suitable for chemotherapy before surgery by the doctor.
- Must have a confirmed diagnosis of high-grade serous ovarian, fallopian tube, or peritoneal cancer.
- Cancer must be at stage III or IV and show the folate receptor alpha (FRα) protein in at least 75% of tumor cells.
- Must have measurable disease according to specific medical criteria.
Exclusion Criteria
- Cannot have certain types of tumors, such as endometrioid, clear cell, or mucinous tumors.
- Cannot have a history of specific lung diseases or have been treated with certain cancer therapies before, except for one cycle of carboplatin.
- Cannot have certain eye conditions or a history of eye surgeries that are not fully healed.
- Cannot have had another cancer within the last 3 years, except for certain skin cancers or cervical/breast carcinoma in situ.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham (UAB) Hospital /ID# 274793 | 35294 | Birmingham | Alabama |
| California Pacific Medical Center /ID# 275329 | 94109 | San Francisco | California |
| Ridley Tree Cancer Center /ID# 275219 | 93105 | Santa Barbara | California |
| Danbury Hospital, Western Connecticut Health Network /ID# 274783 | 06810 | Danbury | Connecticut |
| Norwalk Hospital /ID# 274561 | 06856 | Norwalk | Connecticut |
| Jupiter Medical Center /ID# 276616 | 33458 | Jupiter | Florida |
| Mount Sinai Medical Center /ID# 274868 | 33140 | Miami | Florida |
| OSF St. Francis Medical Center /ID# 274752 | 61637-0001 | Peoria | Illinois |
| Women'S Cancer Care /ID# 276469 | 70433 | Covington | Louisiana |
| University Medical Center New Orleans /ID# 274755 | 70112 | New Orleans | Louisiana |
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