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

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 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.

Why it matters

Who can join: the full rules

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 it's running

• First Physicians Group /ID# 272180
  Sarasota, Florida, United States Recruiting
• St. Elizabeth Medical Center - Edgewood /ID# 272113
  Edgewood, Kentucky, United States Recruiting
• Baptist Health Lexington /ID# 272211
  Lexington, Kentucky, United States Recruiting
• UMass Memorial Medical Center - Belmont Street /ID# 272122
  Worcester, Massachusetts, United States Recruiting
• Karmanos Cancer Institute - Detroit /ID# 272112
  Detroit, Michigan, United States Recruiting
• Allegheny Health Network West Penn Hospital /ID# 272267
  Pittsburgh, Pennsylvania, United States Recruiting

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PARP inhibitor with or without an angiogenesis inhibitor for HRD advanced ovarian, fallopian-tube, or primary peritoneal cancer

  This trial will test whether adding the angiogenesis drug bevacizumab to a PARP inhibitor helps people with homologous recombination deficient (HRD) stage III–IV ovarian, fallopian-tube, or primary peritoneal cancer.

  Recruiting Phase 2/3 N.N. Alexandrov National Cancer Centre · Minsk, Lesnoy · NCT07472140

• Aitua plus Nab-Paclitaxel and Carboplatin before surgery for advanced high-grade serous ovarian cancer

  This trial tests whether adding the PD-1/CTLA-4 bispecific antibody Aitua to standard neoadjuvant chemotherapy helps achieve complete tumor removal before interval debulking surgery in newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer patients who are not expected to be debulked to no visib

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07432594

• Giving TORL-1-23 with chemotherapy before initial surgery for advanced ovarian, fallopian tube, and primary peritoneal cancer

  This study will test whether adding TORL-1-23 to standard paclitaxel and carboplatin before initial surgery helps women with advanced (FIGO III/IV) ovarian, fallopian tube, or primary peritoneal cancer whose tumors are CLDN6-positive.

  Recruiting at 7 sites Phase 1/2 TORL Biotherapeutics, LLC · Fullerton, California and 6 other locations · NCT07322094

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

  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.

  Recruiting at 71 sites Phase 2 AbbVie · Birmingham, Alabama and 72 other locations · NCT06890338

• Carboplatin and Mirvetuximab for Advanced Ovarian Cancer Treatment

  This study is testing if a combination of carboplatin and mirvetuximab can help women with advanced ovarian cancer do better after their initial chemotherapy before surgery.

  Recruiting at 9 sites Phase 2 University of Alabama at Birmingham · Birmingham, Alabama and 8 other locations · NCT04606914

• Real-world use of mirvetuximab soravtansine in FRα-positive platinum-resistant ovarian, fallopian tube, and peritoneal cancer

  This study tests how mirvetuximab soravtansine works in real-world adults with FRα-positive platinum-resistant ovarian, fallopian tube, or peritoneal cancer.

  Recruiting AbbVie · Vienna · NCT07896421

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.