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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-28

Study Completion Date

2028-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced High-Grade Epithelial Ovarian Primary Peritoneal Fallopian Tube Cancers High Folate Receptor-Alpha Expression Platinum Resistant

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Advanced High-Grade Epithelial Ovarian Primary Peritoneal Fallopian Tube Cancers High Folate Receptor-Alpha Expression Platinum Resistant Mirvetuximab Soravtansine MIRV IMGN853

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Randomized Phase 2 Cohort: Arm A

Participants will receive Mirvetuximab Soravtansine at the standard dose on Day 1 of a 21-day cycle.

Group Type EXPERIMENTAL

Mirvetuximab Soravtansine

Intervention Type DRUG

intravenous (IV) infusion

Randomized Phase 2 Cohort: Arm B

Participants will receive Mirvetuximab Soravtansine at a lower dose than the standard dose on Day 1 and Day 15 of a 28-day cycle .

Group Type EXPERIMENTAL

Mirvetuximab Soravtansine

Intervention Type DRUG

intravenous (IV) infusion

Hepatic Impairment Cohort : Mirvetuximab Soravtansine

Participants will receive Mirvetuximab Soravtansine on Day 1 of a 21-day cycle. Different doses will be given to groups of patients to identify a safe and effective dose.

Group Type EXPERIMENTAL

Mirvetuximab Soravtansine

Intervention Type DRUG

intravenous (IV) infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mirvetuximab Soravtansine

intravenous (IV) infusion

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MIRV IMGN853

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

First Physicians Group /ID# 272180

Sarasota, Florida, United States

Site Status RECRUITING

St. Elizabeth Medical Center - Edgewood /ID# 272113

Edgewood, Kentucky, United States

Site Status RECRUITING

Baptist Health Lexington /ID# 272211

Lexington, Kentucky, United States

Site Status RECRUITING

UMass Memorial Medical Center /ID# 272122

Worcester, Massachusetts, United States

Site Status RECRUITING

Karmanos Cancer Institute - Detroit /ID# 272112

Detroit, Michigan, United States

Site Status RECRUITING

Allegheny Health Network West Penn Hospital /ID# 272267

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Blacktown Hospital /ID# 272182

Blacktown, New South Wales, Australia

Site Status RECRUITING

Newcastle Private Hosptial /ID# 272213

Lambton Heights, New South Wales, Australia

Site Status RECRUITING

Royal Brisbane and Women's Hospital /ID# 272123

Brisbane, Queensland, Australia

Site Status RECRUITING

Icon Cancer Centre Chermside /ID# 272220

Chermside, Queensland, Australia

Site Status RECRUITING

Ballarat Base Hospital /ID# 272240

Ballarat, Victoria, Australia

Site Status RECRUITING

Monash Health - Monash Medical Centre /ID# 272234

Clayton, Victoria, Australia

Site Status RECRUITING

Sir Charles Gairdner Hospital /ID# 272116

Nedlands, Western Australia, Australia

Site Status RECRUITING

Algemeen Ziekenhuis klina /ID# 272127

Brasschaat, Antwerpen, Belgium

Site Status RECRUITING

AZ Maria Middelares /ID# 272186

Ghent, Oost-Vlaanderen, Belgium

Site Status RECRUITING

National Cancer Center /ID# 272265

Goyang-si, Gyeonggido, South Korea

Site Status RECRUITING

CHA Bundang Medical Center /ID# 271590

Seongnam, Gyeonggido, South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital /ID# 271594

Seongnam-si, Gyeonggido, South Korea

Site Status RECRUITING