Combining carboplatin with mirvetuximab soravtansine before surgery for FRα-positive advanced serous ovarian, fallopian tube, or primary peritoneal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm Phase 2 neoadjuvant trial enrolling adults with newly diagnosed FIGO stage III–IV high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that express folate receptor alpha (FRα) by a prespecified IHC cutoff. About 140 participants at roughly 80 U.S. sites will receive intravenous mirvetuximab soravtansine combined with carboplatin (and per protocol additions such as bevacizumab where allowed) prior to interval debulking surgery. The study uses imaging and RECIST 1.1 measurable disease criteria, plus safety monitoring, to measure anti-tumor activity and tolerability of the neoadjuvant combination. Centralized FRα testing is required to confirm eligibility.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• University of Alabama at Birmingham (UAB) Hospital /ID# 274793
  Birmingham, Alabama, United States Recruiting
• Usa Mitchell Cancer Institute /ID# 276022
  Mobile, Alabama, United States Recruiting
• Kaiser Permanente - Irvine /ID# 276924
  Irvine, California, United States Recruiting
• UCLA - University of California Los Angeles Medical Center /ID# 274566
  Los Angeles, California, United States Recruiting
• Scripps Md Anderson - Prebys Cancer Center /ID# 276891
  San Diego, California, United States Recruiting
• California Pacific Medical Center - Van Ness Campus /ID# 275329
  San Francisco, California, United States Recruiting

+23 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.