NCT06682988 · AbbVie
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
What this study is about
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 effectiveness 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 experimental antibody drug conj
View original scientific description
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).
Interventions
DRUG
Mirvetuximab Soravtansine
intravenous (IV) infusion
Primary outcome measures
Randomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs)
Time frame: Up to Approximately 24 months
An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related.
Randomized Phase 2 Cohort: Percentage of Participants who Achieved Objective response rate (ORR)
Time frame: Up to Approximately 24 months
ORR is defined as best response of confirmed complete response (CR) or partial response (PR), as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Hepatic Impairment Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine
Time frame: Up to Approximately 24 months
Cmax of MIRV
Hepatic Impairment Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine
Time frame: Up to Approximately 24 months
AUC of MIRV
Hepatic Impairment Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine
Time frame: Up to Approximately 24 months
Ctrough of MIRV
Hepatic Impairment Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine
Time frame: Up to Approximately 24 months
Vss) of MIRV
Hepatic Impairment Cohort: Time to Maximal Concentration (Tmax) of Mirvetuximab Soravtansine
Time frame: Up to Approximately 24 months
Tmax of MIRV
Hepatic Impairment Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine
Time frame: Up to Approximately 24 months
t1/2 of MIRV
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Sarasota, Florida
- Edgewood, Kentucky
- Lexington, Kentucky
- Worcester, Massachusetts
- Detroit, Michigan
- Pittsburgh, Pennsylvania
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 26, 2026 · Source of record for eligibility and locations