Study of Carboplatin and Mirvetuximab Soravtansine for Ovarian, Fallopian Tube, or Peritoneal Cancer

This study is looking at how safe and effective a combination of two drugs, carboplatin and mirvetuximab soravtansine, is for people with newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer. These cancers must have a protein called folate receptor alpha (FRα). Mirvetuximab soravtansine is an investigational drug that targets cancer cells with FRα. The study aims to see if this treatment can shrink tumors. You may be able to join if you are an adult woman with one of these cancers, have a good general health status, and your doctor thinks you are a good candidate for this type of chemotherapy. The study plans to enroll about 140 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 140 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study, objective response, will be measured for up to approximately 3 years.

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NCT06890338

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
PHASE2Ages 18+InterventionalTreatment
AbbVie
~140 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:CarboplatinMirvetuximab SoravtansineBevacizumab

At a glance

Recruiting sites
67 of 68 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response (OR) by Independent Central Review (ICR)
Measured over Up to Approximately 3 years
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Neoadjuvant
68 sites across 28 states
Ohio6
Texas6
California4
New York4
North Carolina4
Virginia4
Connecticut3
Illinois3
  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

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Eligibility criteria

Inclusion

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.

Exclusion

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.
  • 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).