A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
Condition(s) studied
Investigational drug(s) / intervention(s)
Carboplatin: Intravenous (IV) infusion
Mirvetuximab Soravtansine: Intravenous (IV) infusion
Bevacizumab: Intravenous (IV) infusion (per investigator's discretion)
Study summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC).
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States.
Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years .
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Eligibility
Primary outcome measure(s)
- Objective Response (OR) by Independent Central Review (ICR) — Up to Approximately 3 years
OR is defined as the best overall response of radiographic complete response (CR) or partial response (PR) as assessed by ICR using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including interval debulking surgery (IDS).
Trial sites (73)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham (UAB) Hospital /ID# 274793 | Birmingham | Alabama | Recruiting |
| Usa Mitchell Cancer Institute /ID# 276022 | Mobile | Alabama | Recruiting |
| Kaiser Permanente - Irvine /ID# 276924 | Irvine | California | Recruiting |
| UCLA - University of California Los Angeles Medical Center /ID# 274566 | Los Angeles | California | Recruiting |
| Scripps Md Anderson - Prebys Cancer Center /ID# 276891 | San Diego | California | Recruiting |
| California Pacific Medical Center - Van Ness Campus /ID# 275329 | San Francisco | California | Recruiting |
| Ridley Tree Cancer Center /ID# 275219 | Santa Barbara | California | Active Not Recruiting |
| Danbury Hospital, Western Connecticut Health Network /ID# 274783 | Danbury | Connecticut | Recruiting |
| Yale University School of Medicine /ID# 275794 | New Haven | Connecticut | Recruiting |
| Norwalk Hospital /ID# 274561 | Norwalk | Connecticut | Recruiting |
| Jupiter Medical Center /ID# 276616 | Jupiter | Florida | Recruiting |
| Mount Sinai Medical Center /ID# 274868 | Miami Beach | Florida | Completed |
| Rush Md Anderson Cancer Center /ID# 274926 | Chicago | Illinois | Recruiting |
| University of Chicago Medical Center /ID# 274796 | Chicago | Illinois | Recruiting |
| OSF St. Francis Medical Center /ID# 274752 | Peoria | Illinois | Recruiting |
| Carle Foundation Hospital /ID# 276470 | Urbana | Illinois | Recruiting |
| Parkview Research Center /ID# 274338 | Fort Wayne | Indiana | Recruiting |
| Indiana University Melvin and Bren Simon Cancer Center /ID# 275492 | Indianapolis | Indiana | Recruiting |
| Baptist Health Lexington /ID# 275218 | Lexington | Kentucky | Recruiting |
| Norton Cancer Institute - St. Matthews /ID# 276173 | Louisville | Kentucky | Recruiting |
| Women'S Cancer Care /ID# 276469 | Covington | Louisiana | Recruiting |
| University Medical Center New Orleans /ID# 274755 | New Orleans | Louisiana | Recruiting |
| Willis-Knighton Medical Center /ID# 274310 | Shreveport | Louisiana | Recruiting |
| University of Maryland, Baltimore /ID# 275308 | Baltimore | Maryland | Recruiting |
| Holy Cross Hospital /ID# 275872 | Silver Spring | Maryland | Recruiting |
| University of Minnesota - Minneapolis /ID# 275718 | Minneapolis | Minnesota | Recruiting |
| Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780 | Saint Louis Park | Minnesota | Recruiting |
| University Of Mississippi Medical Center /ID# 276342 | Jackson | Mississippi | Recruiting |
| Cox Medical Center South /ID# 274826 | Springfield | Missouri | Recruiting |
| Mercy David C. Pratt Cancer Center /ID# 275655 | St Louis | Missouri | Recruiting |
| The Center Of Hope /ID# 274313 | Reno | Nevada | Recruiting |
| Dartmouth-Hitchcock Medical Center /ID# 274676 | Lebanon | New Hampshire | Recruiting |
| John Theurer Cancer Center /ID# 275756 | Hackensack | New Jersey | Recruiting |
| Rutgers Cancer Institute of New Jersey /ID# 274358 | New Brunswick | New Jersey | Recruiting |
| Holy Name Medical Center /ID# 276240 | Teaneck | New Jersey | Recruiting |
| Optimum Clinical Research Group /ID# 274583 | Albuquerque | New Mexico | Recruiting |
| Imbert Cancer Center /ID# 275634 | Bay Shore | New York | Recruiting |
| Northwell Health Cancer Institute At Huntington /ID# 276814 | Greenlawn | New York | Recruiting |
| Northwell Health Center for Advanced Medicine. /ID# 275641 | Lake Success | New York | Recruiting |
| Columbia University Irving Medical Center /ID# 276156 | New York | New York | Recruiting |
+ 33 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06890338 on ClinicalTrials.gov ↗ ← All trials in the USA