A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

September 7, 2026 updated by: AbbVie

A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects With FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

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 neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC).

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). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States.

Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years .

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham (UAB) Hospital /ID# 274793
      • Mobile, Alabama, United States, 36604
        • Recruiting
        • Usa Mitchell Cancer Institute /ID# 276022
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles Medical Center /ID# 274566
      • San Diego, California, United States, 92103
        • Recruiting
        • Scripps Md Anderson - Prebys Cancer Center /ID# 276891
      • San Francisco, California, United States, 94109
        • Recruiting
        • California Pacific Medical Center - Van Ness Campus /ID# 275329
      • Santa Barbara, California, United States, 93105
        • Active, not recruiting
        • Ridley Tree Cancer Center /ID# 275219
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Recruiting
        • Danbury Hospital, Western Connecticut Health Network /ID# 274783
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University School of Medicine /ID# 275794
      • Norwalk, Connecticut, United States, 06856
        • Recruiting
        • Norwalk Hospital /ID# 274561
    • Florida
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Jupiter Medical Center /ID# 276616
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center /ID# 274868
        • Contact:
          • Site Coordinator
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Rush Md Anderson Cancer Center /ID# 274926
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center /ID# 274796
      • Peoria, Illinois, United States, 61637-0001
        • Recruiting
        • OSF St. Francis Medical Center /ID# 274752
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Foundation Hospital /ID# 276470
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Recruiting
        • Parkview Research Center /ID# 274338
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Melvin and Bren Simon Cancer Center /ID# 275492
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health Lexington /ID# 275218
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Norton Cancer Institute - St. Matthews /ID# 276173
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Women'S Cancer Care /ID# 276469
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans /ID# 274755
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Trials 365 /ID# 274310
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland, Baltimore /ID# 275308
      • Silver Spring, Maryland, United States, 20910
        • Recruiting
        • Holy Cross Hospital /ID# 275872
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455-0341
        • Recruiting
        • University of Minnesota - Minneapolis /ID# 275718
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University Of Mississippi Medical Center /ID# 276342
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Cox Medical Center South /ID# 274826
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy David C. Pratt Cancer Center /ID# 275655
    • Nevada
      • Reno, Nevada, United States, 89511
        • Recruiting
        • The Center Of Hope /ID# 274313
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth-Hitchcock Medical Center /ID# 274676
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center /ID# 275756
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey /ID# 274358
      • Teaneck, New Jersey, United States, 07666
        • Recruiting
        • Holy Name Medical Center /ID# 276240
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • Optimum Clinical Research Group /ID# 274583
    • New York
      • Bay Shore, New York, United States, 11706
        • Recruiting
        • Imbert Cancer Center /ID# 275634
      • Greenlawn, New York, United States, 11740
        • Recruiting
        • Northwell Health Cancer Institute At Huntington /ID# 276814
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health Center for Advanced Medicine. /ID# 275641
      • Rego Park, New York, United States, 11374
        • Recruiting
        • Northwell Health Queens Cancer Center /ID# 274850
      • West Islip, New York, United States, 11795
        • Recruiting
        • Good Samaritan Hospital Medical Center /ID# 274938
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina Medical Center /ID# 275307
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Atrium Health Levine Cancer Institute /ID# 274557
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University - Brody School of Medicine /ID# 275770
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Atrium Health Wake Forest Baptist Medical Center /ID# 276952
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Recruiting
        • Sanford Fargo Medical Center - Fargo /ID# 275489
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic - Cleveland /ID# 276133
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic - Cleveland /ID# 278273
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic - Cleveland /ID# 278274
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • Metrohealth Medical Center - Cleveland /ID# 276664
      • Columbus, Ohio, United States, 43219
        • Recruiting
        • The Mark H Zangmeister Center /ID# 275106
      • Kettering, Ohio, United States, 45429
        • Recruiting
        • Kettering Medical Center /ID# 274365
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Oncology Associates of Oregon, P.C. /ID# 275006
      • Tigard, Oregon, United States, 97223
        • Recruiting
        • Compass Oncology - West - Tigard /ID# 275101
        • Contact:
          • Site Coordinator
          • Phone Number: (971) 708-7600
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St. Lukes University Hospital /ID# 274362
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 275612
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women & Infants Hospital /ID# 274716
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute - Sioux Falls /ID# 276226
      • Sioux Falls, South Dakota, United States, 57104
        • Recruiting
        • Sanford Cancer Center /ID# 274901
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Oncology - Austin Central /ID# 275046
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Texas Oncology - Fort Worth Cancer Center /ID# 275043
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital /ID# 274568
        • Contact:
          • Site Coordinator
          • Phone Number: 713.441.3250
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology - San Antonio Medical Center - Research Drive /ID# 275090
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Texas Oncology - The Woodlands /ID# 275015
      • Tyler, Texas, United States, 75702
        • Recruiting
        • Texas Oncology - Northeast Texas /ID# 275057
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • UVA Health University Hospital /ID# 275309
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 276456
      • Norfolk, Virginia, United States, 23502-2800
        • Recruiting
        • Virginia Oncology Associates- Norfolk (Brock) /ID# 275227
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Roanoke Memorial Hospital /ID# 274684
    • Washington
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center & Children'S Hospital /ID# 274585
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University School of Medicine /ID# 274556

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Be judged by the investigator and/or treating physician to be an appropriate candidate to receive neoadjuvant chemotherapy.
  • Diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer.

  • Participant meets the following disease criteria:

    • Stage III or IV disease by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system, and
    • Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of >= 75% of viable tumor cells with moderate >= 2+ membrane staining by the Ventana Folate Receptor Alpha (VENTANA FOLR1) assay, FOLR1 Eligibility Testing - Ventana FOLR1 (FOLR1-2.1) RxDx - Commercial or Central, and
    • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria.

Exclusion Criteria:

  • Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor.
  • Previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis.
  • Previously treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin

  • Participants with the following ocular history and/or concurrent disorders:

    • History of corneal transplantation;
    • Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery;
    • Confluent superficial punctate keratopathy (SPK) not expected to resolve to non-confluence or better within the screening window with standard of care (SOC) intervention;
    • Active or chronic clinically significant (>= Grade 3) corneal dystrophy (e.g., Fuchs dystrophy);
    • Active ocular conditions requiring ongoing treatment/monitoring, such as glaucoma, which is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema or an ocular condition with high risk of retinal detachment;
    • Monocular vision with visual acuity in the worse eye, worse than 20/200 or visual fields less than 20 degrees (i.e., functional blindness in at least one eye).
  • History of other malignancy within 3 years prior to signing study consent. -- Note: Participants with tumors with a negligible risk for metastasis or death (e.g., adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carboplatin + Mirvetuximab Soravtansine
Participants will receive carboplatin in combination with mirvetuximab soravtansine on Day 1 of a 21-day cycle per dose +/- Bevacizumab per investigator's discretion.
Drug: Carboplatin
Intravenous (IV) infusion
Drug: Mirvetuximab Soravtansine
Intravenous (IV) infusion
Other Names:
  • IMGN853
  • MIRV
  • ELAHERE™
Drug: Bevacizumab
Intravenous (IV) infusion (per investigator's discretion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response (OR) by Independent Central Review (ICR)
Time Frame: Up to Approximately 3 years
OR is defined as the best overall response of radiographic complete response (CR) or partial response (PR) as assessed by ICR using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including interval debulking surgery (IDS).
Up to Approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Adverse Events (AE)
Time Frame: Up to Approximately 3 years
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Up to Approximately 3 years
Percentage of Participants with AEs leading to study drug discontinuation or dose modification
Time Frame: Up to Approximately 3 years
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Up to Approximately 3 years
Disease Control by ICR
Time Frame: Up to Approximately 3 years
Disease control defined as CR, PR, or stable disease (SD) as assessed by ICR per RECIST Version 1.1 prior to subsequent anticancer therapy including IDS.
Up to Approximately 3 years
Disease control by Investigator
Time Frame: Up to Approximately 3 years
Disease control defined as CR, PR, or stable disease (SD) as assessed by investigator per RECIST Version 1.1 prior to subsequent anticancer therapy including IDS.
Up to Approximately 3 years
Percentage of Participants With CA-125 Confirmed Response Per Gynecologic Cancer Intergroup (GCIG) Criteria
Time Frame: Up to Approximately 3 years
The GCIG CA-125 response was defined as at least 50% reduction in CA-125.
Up to Approximately 3 years
Percentage of Participants that Underwent Interval debulking surgery (IDS)
Time Frame: Up to Approximately 3 years
Percentage of participants that underwent IDS during the course of the study treatment
Up to Approximately 3 years
Objective Response (OR) by Investigator
Time Frame: Up to Approximately 3 years
OR is defined as the best overall response of radiographic CR or PR as assessed by investigator using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including IDS.
Up to Approximately 3 years
Progression-Free Survival (PFS) by investigator
Time Frame: Up to Approximately 3 years
PFS by investigator, defined as the time from the date of C1D1 until PD per RECIST v1.1 as assessed by investigator or death from any cause, whichever occurs first.
Up to Approximately 3 years
Percentage of participants with complete tumor cytoreduction at IDS
Time Frame: Up to Approximately 3 years
Complete tumor cytoreduction is defined as the absence of macroscopically visible residual disease at the end of the surgery
Up to Approximately 3 years
Percentage of participants with Incomplete Tumor Cytoreduction at IDS
Time Frame: Up to Approximately 3 years
Defined as macroscopically visible residual tumor (≤ 1 cm or > 1cm) at the end of surgery.
Up to Approximately 3 years
Change from baseline in disease-related symptoms as measured by the NCCN-FACT Ovarian Symptom Index (NFOSI-18) disease symptom subscale - physical (DRS-P)
Time Frame: Up to Approximately 3 years
The NFOSI-18 provides a total score that sums all 18 items, plus 2 multi-item scales that assess physical disease-related symptoms (DRS-P; 9 items) and general function/well-being (F/WB; 3 items).
Up to Approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Collaborators

GOG Foundation

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2025

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 24, 2025

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 7, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M25-231
  • GOG-3115 (Other Identifier: GOG)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe