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.

NCT06890338 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: M25-231GOG-3115
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 64

Brief Summary

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.

Conditions

Fallopian Tube Cancer; Epithelial Ovarian Cancer; Primary Peritoneal Cancer; Neoadjuvant

Keywords

Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; Neoadjuvant; Interval Debulking Surgery; Mirvetuximab Soravtansine; MIRV; IMGN853; ELAHERE(R); Carboplatin; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Objective Response (OR) by Independent Central Review (ICR)

  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 Outcomes (11)

• Percentage of Participants with Adverse Events (AE)

  Up to Approximately 3 years

• Percentage of Participants with AEs leading to study drug discontinuation or dose modification

  Up to Approximately 3 years

• Objective Response (OR) by Investigator

  Up to Approximately 3 years

• Disease Control by ICR

  Up to Approximately 3 years

• Disease control by Investigator

  Up to Approximately 3 years

Study Arms (1)

Carboplatin + Mirvetuximab Soravtansine

EXPERIMENTAL

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; Drug: Mirvetuximab Soravtansine; Drug: Bevacizumab

Interventions

Carboplatin DRUG

Intravenous (IV) infusion

Carboplatin + Mirvetuximab Soravtansine

Mirvetuximab Soravtansine DRUG

Intravenous (IV) infusion

Also known as: MIRV, IMGN853, ELAHERE™

Carboplatin + Mirvetuximab Soravtansine

Bevacizumab DRUG

Intravenous (IV) infusion (per investigator's discretion)

Carboplatin + Mirvetuximab Soravtansine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead
• GOG Foundation: collaborator

Study Sites (64)

University of Alabama at Birmingham (UAB) Hospital /ID# 274793

Birmingham, Alabama, 35294, United States

RECRUITING

Usa Mitchell Cancer Institute /ID# 276022

Mobile, Alabama, 36604, United States

RECRUITING

University of California Los Angeles Medical Center /ID# 274566

Los Angeles, California, 90095, United States

RECRUITING

Scripps Md Anderson - Prebys Cancer Center /ID# 276891

San Diego, California, 92103, United States

RECRUITING

California Pacific Medical Center /ID# 275329

San Francisco, California, 94109, United States

RECRUITING

Ridley Tree Cancer Center /ID# 275219

Santa Barbara, California, 93105, United States

ACTIVE NOT RECRUITING

Danbury Hospital, Western Connecticut Health Network /ID# 274783

Danbury, Connecticut, 06810, United States

RECRUITING

Yale University School of Medicine /ID# 275794

New Haven, Connecticut, 06510, United States

RECRUITING

Norwalk Hospital /ID# 274561

Norwalk, Connecticut, 06856, United States

RECRUITING

Jupiter Medical Center /ID# 276616

Jupiter, Florida, 33458, United States

RECRUITING

Mount Sinai Medical Center /ID# 274868

Miami Beach, Florida, 33140, United States

RECRUITING

Rush Md Anderson Cancer Center /ID# 274926

Chicago, Illinois, 60607, United States

RECRUITING

OSF St. Francis Medical Center /ID# 274752

Peoria, Illinois, 61637-0001, United States

RECRUITING

Parkview Research Center /ID# 274338

Fort Wayne, Indiana, 46845, United States

RECRUITING

Indiana University Melvin and Bren Simon Cancer Center /ID# 275492

Indianapolis, Indiana, 46202, United States

RECRUITING

Baptist Health Lexington /ID# 275218

Lexington, Kentucky, 40503, United States

RECRUITING

Norton Cancer Institute - St. Matthews /ID# 276173

Louisville, Kentucky, 40207, United States

RECRUITING

Women'S Cancer Care /ID# 276469

Covington, Louisiana, 70433, United States

RECRUITING

University Medical Center New Orleans /ID# 274755

New Orleans, Louisiana, 70112, United States

RECRUITING

Trials 365 /ID# 274310

Shreveport, Louisiana, 71103, United States

RECRUITING

University of Maryland, Baltimore /ID# 275308

Baltimore, Maryland, 21201, United States

RECRUITING

Holy Cross Hospital /ID# 275872

Silver Spring, Maryland, 20910, United States

RECRUITING

University of Minnesota - Minneapolis /ID# 275718

Minneapolis, Minnesota, 55455-0341, United States

RECRUITING

Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780

Saint Louis Park, Minnesota, 55416, United States

RECRUITING

University Of Mississippi Medical Center /ID# 276342

Jackson, Mississippi, 39216, United States

RECRUITING

Cox Medical Center South /ID# 274826

Springfield, Missouri, 65807, United States

RECRUITING

Mercy Hospital St. Louis /ID# 275655

St Louis, Missouri, 63141, United States

RECRUITING

The Center Of Hope /ID# 274313

Reno, Nevada, 89511, United States

RECRUITING

Dartmouth-Hitchcock Medical Center /ID# 274676

Lebanon, New Hampshire, 03756, United States

RECRUITING

Rutgers Cancer Institute of New Jersey /ID# 274358

New Brunswick, New Jersey, 08901, United States

RECRUITING

Holy Name Medical Center /ID# 276240

Teaneck, New Jersey, 07666, United States

RECRUITING

Optimum Clinical Research Group /ID# 274583

Albuquerque, New Mexico, 87109, United States

RECRUITING

Imbert Cancer Center /ID# 275634

Bay Shore, New York, 11706, United States

RECRUITING

Northwell Health Cancer Institute At Huntington /ID# 276814

Greenlawn, New York, 11740, United States

RECRUITING

Northwell Health Center for Advanced Medicine. /ID# 275641

Lake Success, New York, 11042, United States

RECRUITING

Northwell Health Queens Cancer Center /ID# 274850

Rego Park, New York, 11374, United States

RECRUITING

University of North Carolina Medical Center /ID# 275307

Chapel Hill, North Carolina, 27514, United States

RECRUITING

East Carolina University - Brody School of Medicine /ID# 275770

Greenville, North Carolina, 27834, United States

RECRUITING

Atrium Health Wake Forest Baptist Medical Center /ID# 276952

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Sanford Fargo Medical Center - Fargo /ID# 275489

Fargo, North Dakota, 58102, United States

RECRUITING

Cleveland Clinic - Cleveland /ID# 276133

Cleveland, Ohio, 44195, United States

RECRUITING

Cleveland Clinic - Cleveland /ID# 278273

Cleveland, Ohio, 44195, United States

RECRUITING

Cleveland Clinic - Cleveland /ID# 278274

Cleveland, Ohio, 44195, United States

RECRUITING

The Mark H Zangmeister Center /ID# 275106

Columbus, Ohio, 43219, United States

RECRUITING

Kettering Medical Center /ID# 274365

Kettering, Ohio, 45429, United States

RECRUITING

Oncology Associates of Oregon, P.C. /ID# 275006

Eugene, Oregon, 97401, United States

RECRUITING

Compass Oncology - West - Tigard /ID# 275101

Tigard, Oregon, 97223, United States

RECRUITING

St. Lukes University Hospital /ID# 274362

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

University of Pennsylvania /ID# 275612

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Women & Infants Hospital /ID# 274716

Providence, Rhode Island, 02905, United States

RECRUITING

Sanford Cancer Center /ID# 274901

Sioux Falls, South Dakota, 57104, United States

RECRUITING

Avera Cancer Institute - Sioux Falls /ID# 276226

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Texas Oncology - Austin Central /ID# 275046

Austin, Texas, 78731, United States

RECRUITING

Texas Oncology - Fort Worth Cancer Center /ID# 275043

Fort Worth, Texas, 76104, United States

RECRUITING

Houston Methodist Hospital /ID# 274568

Houston, Texas, 77030, United States

RECRUITING

Texas Oncology - San Antonio Medical Center - Research Drive /ID# 275090

San Antonio, Texas, 78240, United States

RECRUITING

Texas Oncology - The Woodlands /ID# 275015

The Woodlands, Texas, 77380, United States

RECRUITING

Texas Oncology - Northeast Texas /ID# 275057

Tyler, Texas, 75702, United States

RECRUITING

UVA Health University Hospital /ID# 275309

Charlottesville, Virginia, 22903, United States

RECRUITING

Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 276456

Fairfax, Virginia, 22031, United States

RECRUITING

Virginia Oncology Associates- Norfolk (Brock) /ID# 275227

Norfolk, Virginia, 23502-2800, United States

RECRUITING

Carilion Roanoke Memorial Hospital /ID# 274684

Roanoke, Virginia, 24014, United States

RECRUITING

Providence Sacred Heart Medical Center & Children'S Hospital /ID# 274585

Spokane, Washington, 99204, United States

RECRUITING

West Virginia University School of Medicine /ID# 274556

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

Carboplatin; mirvetuximab soravtansine; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 24, 2025
• Study Start: November 21, 2025
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (64)