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Combining carboplatin with mirvetuximab soravtansine before surgery for FRα-positive advanced serous 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

Phase 2 Interventional AbbVie · NCT06890338

This will test whether giving mirvetuximab soravtansine with carboplatin before surgery helps people with newly diagnosed FRα-positive advanced-stage serous ovarian, fallopian tube, or primary peritoneal cancer.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment140 (estimated)
Ages18 Years and up
SexFemale
SponsorAbbVie Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation, mirvetuximab
Locations61 sites (Birmingham, Alabama and 60 other locations)
Trial IDNCT06890338 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with newly diagnosed high-grade serous FIGO stage III–IV ovarian, fallopian tube, or primary peritoneal cancer who are FRα-positive by the required IHC cutoff, have measurable disease, an ECOG 0–2, and are considered appropriate for neoadjuvant chemotherapy.

Not a fit: Patients with non-serous histologies (for example endometrioid, clear cell, mucinous), low or absent FRα expression, or who are not candidates for neoadjuvant chemotherapy or interval surgery are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the combination could shrink tumors before surgery and increase the chance of a more complete debulking and improved outcomes.

How similar studies have performed: Earlier clinical work with mirvetuximab soravtansine has shown anti-tumor activity in FRα-positive ovarian cancer, but combining it with neoadjuvant carboplatin in newly diagnosed patients is less well studied.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal CancerNeoadjuvantInterval Debulking SurgeryMirvetuximab SoravtansineMIRVIMGN853
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.