OncoMatch/Clinical Trials/NCT06682988
A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine
Is NCT06682988 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Mirvetuximab Soravtansine for advanced high-grade epithelial ovarian cancer.
Treatment: Mirvetuximab Soravtansine — Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα). Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide. The total study duration will be approximately 24 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Ovarian Cancer
Biomarker criteria
Required: FOLR1 expression (≥ 75% of tumor staining at 2+ intensity)
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)
Disease stage
Grade: high-grade
high-grade serous epithelial ovarian cancer; measurable disease by RECIST v1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: platinum-based chemotherapy
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.
Cannot have received: platinum-based chemotherapy
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- First Physicians Group /ID# 272180 · Sarasota, Florida
- St. Elizabeth Medical Center - Edgewood /ID# 272113 · Edgewood, Kentucky
- Baptist Health Lexington /ID# 272211 · Lexington, Kentucky
- UMass Memorial Medical Center - Belmont Street /ID# 272122 · Worcester, Massachusetts
- Karmanos Cancer Institute - Detroit /ID# 272112 · Detroit, Michigan
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06682988 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior platinum-based chemotherapy disqualifies patients from enrollment.
Does this trial require FOLR1?
Yes, FOLR1 expression is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify