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Study of Mirvetuximab Soravtansine for Ovarian, Peritoneal, or Fallopian Tube Cancers

This study is testing a drug called Mirvetuximab Soravtansine for advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers that have not responded to platinum-based chemotherapy (platinum-resistant). Mirvetuximab Soravtansine is designed to target cancer cells that have high levels of a protein called folate receptor alpha (FRα). The main goals are to see how safe the drug is (looking at side effects, especially eye-related ones) and how well it shrinks tumors. You may be eligible if you are a woman aged 18 or older with one of these cancers, and your cancer has high FRα expression and is platinum-resistant. The study plans to enroll 110 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 110 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 24 months to assess side effects and tumor response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
AbbVie
~110 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:Mirvetuximab Soravtansine

At a glance

Recruiting sites
52 of 52 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Randomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs)
Measured over Up to Approximately 24 months
+7 more outcomes measured

Conditions

Advanced High-Grade Epithelial Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancers

Explore related trials

Fallopian Tube CarcinomaHigh-Grade Serous Epithelial Ovarian CancerPrimary Peritoneal CancerFOSL1 wt Allele

Where it's being run

52 sites across 37 states
Spain6
Seoul Teugbyeolsi5
Gyeonggido3
Kentucky2
New South Wales2
Queensland2
Victoria2
Florida1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Randomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs)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)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 SoravtansineUp to Approximately 24 months

    Cmax of MIRV

  • Hepatic Impairment Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab SoravtansineUp to Approximately 24 months

    AUC of MIRV

  • Hepatic Impairment Cohort: Trough Concentration (Ctrough) of Mirvetuximab SoravtansineUp to Approximately 24 months

    Ctrough of MIRV

  • Hepatic Impairment Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab SoravtansineUp to Approximately 24 months

    Vss) of MIRV

  • Hepatic Impairment Cohort: Time to Maximal Concentration (Tmax) of Mirvetuximab SoravtansineUp to Approximately 24 months

    Tmax of MIRV

  • Hepatic Impairment Cohort: Terminal Half-Life (t1/2) of Mirvetuximab SoravtansineUp to Approximately 24 months

    t1/2 of MIRV