Featured Trial

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

Study Identifier
IMGN853-0425
CT.gov Identifier
NCT06682988
EudraCT Identifier
Not available
EUCTIS ID
2024-517184-23-00
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
Sign up for trial alerts

Study Details

This study is for people with a type of cancer called platinum-resistant ovarian cancer, as well as certain cancers of the peritoneum or fallopian tubes which are sometimes difficult to treat with standard medicines. The study is investigating the efficacy and safety of an alternative treatment schedule for a US approved medicine called Mirvetuximab Soravtansine (MIRV), which is designed to find and kill cancer cells that have a high amount of a protein called folate receptor alpha (FRα). MIRV works by using an antibody, which is a kind of protein, to target the cancer cells and deliver a drug that destroys them.

Study Details

Medical Condition
  • Ovarian Cancer
  • Gynecologic Cancer - Other
  • Gynecologic Cancer - Fallopian Tube Cancer
    • Study Drug
  • Mirvetuximab Soravtansine
    • Phase
    Phase 2
    Estimated Enrollment
    110 patients

    Participating in our Clinical Trials

    The study has two main groups. In the first group (the Randomised Phase 2 Cohort), participants are divided into two treatment groups, each receiving MIRV on a different schedule—either once every 21 days, or twice every 28 days. The second group (the Hepatic Impairment Cohort) is for people with moderate liver problems and aims to find the best starting dose of MIRV for them. The whole study will last about 24 months (2 years), but an individual’s participation may be less. Patients will continue to get the study medicine until their cancer gets worse, they experience side effects that are too serious, they choose to stop, they pass away, or the sponsor decides to end the study.

    Participants in the study will be monitored for up to two years from the start of their treatment. Those who are still doing well on the treatment after two years may have the option to continue receiving MIRV through typical channels, or through an expanded access program, if it is available/permitted.

    Study Participant Requirements

    Sex
    Female
    Age
    18+ years

    Key Inclusion and Exclusion Criteria

    Participants must:

    • Be 18 or older
    • Have a confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer
    • Be diagnosed with platinum-resistant disease:
      • Have 1 prior line of platinum-based therapy who have received ≥ 4 cycles of platinum and had a response (CR or PR) followed by radiological PD between > 3 months and ≤ 6 months after the date of the last dose of platinum.
      • Have 2 or 3 prior lines of platinum-based therapy who had radiological PD ≤ 6 months after the date of the last dose of platinum.
    • Have a tumor that is positive for FRα expression as determined by the Ventana FOLR1 (FOLR1 2.1) RxDx (commercial) assay the Ventana FOLR1 (FOLR1-2.1) IUO assay, or the Ventana FOLR1 (FOLR-2.1) CDx assay (hereafter referred to collectively as the Ventana FOLR1 assay) (≥ 75% of tumor staining at 2+ intensity).

    Participants must not:

    • Have endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors; or low-grade or borderline ovarian tumor.
    • Have primary platinum-refractory disease, defined as disease that did not respond (CR or PR) or that progressed radiographically within 3 months of the last dose of first-line platinum-containing chemotherapy
    • Had prior treatment with MIRV or other FRα-targeting agents

    Inclusion and 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.

    Study Locations

    Location
    Status
    Location
    First Physicians Group /ID# 272180
    Sarasota, Florida, United States, 34239
    Status
    Recruiting
    Location
    St. Elizabeth Medical Center - Edgewood /ID# 272113
    Edgewood, Kentucky, United States, 41017
    Status
    Recruiting
    Location
    Baptist Health Lexington /ID# 272211
    Lexington, Kentucky, United States, 40503
    Status
    Recruiting
    Location
    UMass Memorial Medical Center - Belmont Street /ID# 272122
    Worcester, Massachusetts, United States, 01605
    Status
    Recruiting
    Location
    Karmanos Cancer Institute - Detroit /ID# 272112
    Detroit, Michigan, United States, 48201
    Status
    Recruiting
    Location
    Allegheny Health Network West Penn Hospital /ID# 272267
    Pittsburgh, Pennsylvania, United States, 15244
    Status
    Recruiting
    Showing {first} - {last} of {total} Results

    MIRV-AA-0006-RM Version 2.0 13Feb2026