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.

Recruiting now · Phase 2

Conditions studied: Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Neoadjuvant

In brief

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.

Key facts

Study ID: NCT06890338
Run by: AbbVie
People needed: 140
Starts: 2025-11-21
Expected to finish: 2030-02-01
Last updated by the study team: 2026-07-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor.
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).
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.

Where it is running

Usa Mitchell Cancer Institute /ID# 276022 — Mobile, Alabama, United States (enrolling)
University of Alabama at Birmingham (UAB) Hospital /ID# 274793 — Birmingham, Alabama, United States (enrolling)
Scripps Md Anderson - Prebys Cancer Center /ID# 276891 — San Diego, California, United States (enrolling)
California Pacific Medical Center - Van Ness Campus /ID# 275329 — San Francisco, California, United States (enrolling)
University of California Los Angeles Medical Center /ID# 274566 — Los Angeles, California, United States (enrolling)
Danbury Hospital, Western Connecticut Health Network /ID# 274783 — Danbury, Connecticut, United States (enrolling)
Yale University School of Medicine /ID# 275794 — New Haven, Connecticut, United States (enrolling)
Norwalk Hospital /ID# 274561 — Norwalk, Connecticut, United States (enrolling)
Jupiter Medical Center /ID# 276616 — Jupiter, Florida, United States (enrolling)
Mount Sinai Medical Center /ID# 274868 — Miami Beach, Florida, United States (enrolling)
Rush Md Anderson Cancer Center /ID# 274926 — Chicago, Illinois, United States (enrolling)
OSF St. Francis Medical Center /ID# 274752 — Peoria, Illinois, United States (enrolling)
Carle Foundation Hospital /ID# 276470 — Urbana, Illinois, United States (enrolling)
Parkview Research Center /ID# 274338 — Fort Wayne, Indiana, United States (enrolling)
Indiana University Melvin and Bren Simon Cancer Center /ID# 275492 — Indianapolis, Indiana, United States (enrolling)
Baptist Health Lexington /ID# 275218 — Lexington, Kentucky, United States (enrolling)
Norton Cancer Institute - St. Matthews /ID# 276173 — Louisville, Kentucky, United States (enrolling)
Women'S Cancer Care /ID# 276469 — Covington, Louisiana, United States (enrolling)
University Medical Center New Orleans /ID# 274755 — New Orleans, Louisiana, United States (enrolling)
Trials 365 /ID# 274310 — Shreveport, Louisiana, United States (enrolling)
University of Maryland, Baltimore /ID# 275308 — Baltimore, Maryland, United States (enrolling)
Holy Cross Hospital /ID# 275872 — Silver Spring, Maryland, United States (enrolling)
University of Minnesota - Minneapolis /ID# 275718 — Minneapolis, Minnesota, United States (enrolling)
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780 — Saint Louis Park, Minnesota, United States (enrolling)
University Of Mississippi Medical Center /ID# 276342 — Jackson, Mississippi, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.