NCT06890338RecruitingPhase 2
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.
A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects With FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 20 Mar 2025
- Start date
- 21 Nov 2025
- Primary completion date
- Feb 2030
- Lead sponsor
- AbbVie
- Diseases
- Ovarian cancer
- NCT number
- NCT06890338
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 140
- From 21 Nov 2025 to the primary completion date, Feb 2030
- 73 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis.
- Previously treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin
- Participants with the following ocular history and/or concurrent disorders:
- History of corneal transplantation;
- Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery;
- Confluent superficial punctate keratopathy (SPK) not expected to resolve to non-confluence or better within the screening window with standard of care (SOC) intervention;
- Active or chronic clinically significant (\>= Grade 3) corneal dystrophy (e.g., Fuchs dystrophy);
- Active ocular conditions requiring ongoing treatment/monitoring, such as glaucoma, which is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema or an ocular condition with high risk of retinal detachment;
- Monocular vision with visual acuity in the worse eye, worse than 20/200 or visual fields less than 20 degrees (i.e., functional blindness in at least one eye).
Other illness
- History of other malignancy within 3 years prior to signing study consent. -- Note: Participants with tumors with a negligible risk for metastasis or death (e.g., adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible.
Other
- Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor.
Who the study is looking for
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Be judged by the investigator and/or treating physician to be an appropriate candidate to receive neoadjuvant chemotherapy.
- Diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer.
- Participant meets the following disease criteria:
- Stage III or IV disease by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system, and
- Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of \>= 75% of viable tumor cells with moderate \>= 2+ membrane staining by the Ventana Folate Receptor Alpha (VENTANA FOLR1) assay, FOLR1 Eligibility Testing - Ventana FOLR1 (FOLR1-2.1) RxDx - Commercial or Central, and
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (73)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Optimum Clinical Research Group /ID# 274583 Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| Texas Oncology - Austin Central /ID# 275046 Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| University of Maryland, Baltimore /ID# 275308 Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Imbert Cancer Center /ID# 275634 Coordinator of this site? Confirm its status | Bay Shore | United States | Recruiting |
| St. Lukes University Hospital /ID# 274362 Coordinator of this site? Confirm its status | Bethlehem | United States | Recruiting |
| University of Alabama at Birmingham (UAB) Hospital /ID# 274793 Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| University of North Carolina Medical Center /ID# 275307 Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Atrium Health Levine Cancer Institute /ID# 274557 Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| UVA Health University Hospital /ID# 275309 Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| University of Chicago Medical Center /ID# 274796 Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Rush Md Anderson Cancer Center /ID# 274926 Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Cleveland Clinic - Cleveland /ID# 276133 Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Metrohealth Medical Center - Cleveland /ID# 276664 Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Cleveland Clinic - Cleveland /ID# 278274 Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Cleveland Clinic - Cleveland /ID# 278273 Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| The Mark H Zangmeister Center /ID# 275106 Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Women'S Cancer Care /ID# 276469 Coordinator of this site? Confirm its status | Covington | United States | Recruiting |
| Danbury Hospital, Western Connecticut Health Network /ID# 274783 Coordinator of this site? Confirm its status | Danbury | United States | Recruiting |
| Oncology Associates of Oregon, P.C. /ID# 275006 Coordinator of this site? Confirm its status | Eugene | United States | Recruiting |
| Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 276456 Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Sanford Fargo Medical Center - Fargo /ID# 275489 Coordinator of this site? Confirm its status | Fargo | United States | Recruiting |
| Parkview Research Center /ID# 274338 Coordinator of this site? Confirm its status | Fort Wayne | United States | Recruiting |
| Texas Oncology - Fort Worth Cancer Center /ID# 275043 Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Northwell Health Cancer Institute At Huntington /ID# 276814 Coordinator of this site? Confirm its status | Greenlawn | United States | Recruiting |
| East Carolina University - Brody School of Medicine /ID# 275770 Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| John Theurer Cancer Center /ID# 275756 Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| Houston Methodist Hospital /ID# 274568 Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Indiana University Melvin and Bren Simon Cancer Center /ID# 275492 Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Kaiser Permanente - Irvine /ID# 276924 Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| University Of Mississippi Medical Center /ID# 276342 Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
| Jupiter Medical Center /ID# 276616 Coordinator of this site? Confirm its status | Jupiter | United States | Recruiting |
| Kettering Medical Center /ID# 274365 Coordinator of this site? Confirm its status | Kettering | United States | Recruiting |
| Northwell Health Center for Advanced Medicine. /ID# 275641 Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
| Dartmouth-Hitchcock Medical Center /ID# 274676 Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
| Baptist Health Lexington /ID# 275218 Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| UCLA - University of California Los Angeles Medical Center /ID# 274566 Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Norton Cancer Institute - St. Matthews /ID# 276173 Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Mount Sinai Medical Center /ID# 274868 Coordinator of this site? Confirm its status | Miami Beach | United States | Completed |
| University of Minnesota - Minneapolis /ID# 275718 Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Usa Mitchell Cancer Institute /ID# 276022 Coordinator of this site? Confirm its status | Mobile | United States | Recruiting |
| West Virginia University School of Medicine /ID# 274556 Coordinator of this site? Confirm its status | Morgantown | United States | Recruiting |
| Rutgers Cancer Institute of New Jersey /ID# 274358 Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Yale University School of Medicine /ID# 275794 Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| University Medical Center New Orleans /ID# 274755 Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Columbia University Irving Medical Center /ID# 276156 Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Virginia Oncology Associates- Norfolk (Brock) /ID# 275227 Coordinator of this site? Confirm its status | Norfolk | United States | Recruiting |
| Norwalk Hospital /ID# 274561 Coordinator of this site? Confirm its status | Norwalk | United States | Recruiting |
| OSF St. Francis Medical Center /ID# 274752 Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 275612 Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| West Penn Hospital /ID# 276028 Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Women & Infants Hospital /ID# 274716 Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
| Northwell Health Queens Cancer Center /ID# 274850 Coordinator of this site? Confirm its status | Rego Park | United States | Recruiting |
| The Center Of Hope /ID# 274313 Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Carilion Roanoke Memorial Hospital /ID# 274684 Coordinator of this site? Confirm its status | Roanoke | United States | Recruiting |
| Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780 Coordinator of this site? Confirm its status | Saint Louis Park | United States | Recruiting |
| Texas Oncology - San Antonio Medical Center - Research Drive /ID# 275090 Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Scripps Md Anderson - Prebys Cancer Center /ID# 276891 Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| California Pacific Medical Center - Van Ness Campus /ID# 275329 Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Ridley Tree Cancer Center /ID# 275219 Coordinator of this site? Confirm its status | Santa Barbara | United States | Active, not recruiting |
| Willis-Knighton Medical Center /ID# 274310 Coordinator of this site? Confirm its status | Shreveport | United States | Recruiting |
| Holy Cross Hospital /ID# 275872 Coordinator of this site? Confirm its status | Silver Spring | United States | Recruiting |
| Avera Cancer Institute - Sioux Falls /ID# 276226 Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Sanford Cancer Center /ID# 274901 Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Providence Sacred Heart Medical Center & Children'S Hospital /ID# 274585 Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| Cox Medical Center South /ID# 274826 Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Mercy David C. Pratt Cancer Center /ID# 275655 Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Holy Name Medical Center /ID# 276240 Coordinator of this site? Confirm its status | Teaneck | United States | Recruiting |
| Texas Oncology - The Woodlands /ID# 275015 Coordinator of this site? Confirm its status | The Woodlands | United States | Recruiting |
| Compass Oncology - West - Tigard /ID# 275101 Coordinator of this site? Confirm its status | Tigard | United States | Recruiting |
| Texas Oncology - Northeast Texas /ID# 275057 Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
| Carle Foundation Hospital /ID# 276470 Coordinator of this site? Confirm its status | Urbana | United States | Recruiting |
| Good Samaritan Hospital Medical Center /ID# 274938 Coordinator of this site? Confirm its status | West Islip | United States | Recruiting |
| Atrium Health Wake Forest Baptist Medical Center /ID# 276952 Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.