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Mirvetuximab soravtansine for platinum-resistant high-grade ovarian, fallopian tube, and primary peritoneal cancer with high folate receptor-alpha

A Randomized Phase 2, Open-label Study of Mirvetuximab Soravtansine in Patients With Platinum-resistant Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-alpha Expression Testing 2 Schedules of Administration for Dose Optimization, With a Separate Cohort to Determine Starting Dose in Patients With Moderate Hepatic Impairment

Phase 2 Interventional AbbVie · NCT06682988

This trial tests whether intravenous mirvetuximab soravtansine helps people with platinum-resistant high-grade ovarian, fallopian tube, or primary peritoneal cancer whose tumors have high folate receptor-alpha.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment110 (estimated)
Ages18 Years and up
SexFemale
SponsorAbbVie Industry-sponsored
Drugs / interventionschemotherapy, Mirvetuximab
Locations37 sites (Sarasota, Florida and 36 other locations)
Trial IDNCT06682988 on ClinicalTrials.gov

What this trial studies

This is a Phase 2 interventional trial testing an antibody–drug conjugate (mirvetuximab soravtansine) that targets folate receptor‑alpha (FRα) on tumor cells to deliver a cell‑killing payload. The study includes a randomized Phase 2 cohort where participants are assigned to one of two dosing schedules, and a separate hepatic impairment cohort to study drug use in patients with liver dysfunction. Key outcomes include safety (adverse events) and changes in disease activity measured radiographically using RECIST criteria. Eligible participants have platinum‑resistant high‑grade epithelial ovarian, primary peritoneal, or fallopian tube cancer with high FRα expression and an ECOG performance status of 0–1.

Who should consider this trial

Good fit: Adults with high‑grade epithelial ovarian, primary peritoneal, or fallopian tube cancer that is platinum‑resistant, whose tumors have high folate receptor‑alpha expression, with ECOG 0–1 and at least one measurable lesion are the intended participants.

Not a fit: Patients whose tumors lack high folate receptor‑alpha expression, who are platinum‑sensitive, have poor performance status, or have significant organ dysfunction are unlikely to benefit from this investigational therapy.

Why it matters

Potential benefit: If successful, this therapy could provide a targeted treatment option that shrinks tumors or slows progression for patients with FRα‑high, platinum‑resistant disease.

How similar studies have performed: Prior studies of mirvetuximab and other FRα‑targeted therapies have demonstrated clinical activity in FRα‑high ovarian cancer, but results have been mixed and definitive randomized benefit remains limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Both Cohorts

* Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
* Participants with platinum-resistant disease:

  * Participants with 1 prior line of platinum-based therapy who have received ≥ 4 cycles of platinum and had a response (complete response (CR) or partial response (PR)) followed by radiological progressive disease (PD) between \> 3 months and ≤ 6 months after the date of the last dose of platinum.
  * Participants with 2 or 3 prior lines of platinum-based therapy who had radiological PD

    * 6 months after the date of the last dose of platinum.
* Participants with progression diagnosed radiographically on or after their most recent line of therapy.
* Participants with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
* Participants with ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).
* Participants with a tumor that is positive for folate receptor alpha (FRα) expression as determined by the Ventana folate receptor 1 (FOLR1) assay (≥ 75% of tumor staining at 2+ intensity).

Exclusion Criteria:

Both Cohorts

* Participants with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or borderline ovarian tumor.
* Participants with primary platinum-refractory disease, defined as disease that did not respond (complete response (CR) or partial response (PR)) or that progressed radiographically within 3 months of the last dose of first-line platinum-containing chemotherapy.
* Participants with serious concurrent illness or clinically relevant active infection as outlined in the protocol
* Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to randomization.

Where this trial is running

Sarasota, Florida and 36 other locations

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 Advanced High-Grade Epithelial OvarianPrimary PeritonealFallopian Tube CancersHigh Folate Receptor-Alpha ExpressionPlatinum ResistantMirvetuximab 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.