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RECRUITING

NCT06890338

PHASE2

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.

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-11-21

Completion Date

2030-02

Last Updated

2026-02-24

Healthy Volunteers

Conditions

Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Neoadjuvant

Interventions

DRUG

Carboplatin

Intravenous (IV) infusion

DRUG

Mirvetuximab Soravtansine

Intravenous (IV) infusion

DRUG

Bevacizumab

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

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * 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, 27 and * Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of \>= 75% of viable tumor cells with moderate (2+) and/or strong (3+) membrane staining by the AbbVie specified vendor with the Ventana Folate Receptor Alpha (FOLR1) assay, 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.

Locations (50)

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

Birmingham, Alabama, United States

Usa Mitchell Cancer Institute /ID# 276022

Mobile, Alabama, United States

Scripps Mercy Hospital /ID# 276891

San Diego, California, United States

California Pacific Medical Center /ID# 275329

San Francisco, California, United States

Ridley Tree Cancer Center /ID# 275219

Santa Barbara, California, United States

Danbury Hospital, Western Connecticut Health Network /ID# 274783

Danbury, Connecticut, United States

Norwalk Hospital /ID# 274561

Norwalk, Connecticut, United States

Jupiter Medical Center /ID# 276616

Jupiter, Florida, United States

Mount Sinai Medical Center /ID# 274868

Miami, Florida, United States

Rush Md Anderson Cancer Center /ID# 274926

Chicago, Illinois, United States

OSF St. Francis Medical Center /ID# 274752

Peoria, Illinois, United States

Parkview Research Center /ID# 274338

Fort Wayne, Indiana, United States

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

Indianapolis, Indiana, United States

Baptist Health Lexington /ID# 275218

Lexington, Kentucky, United States

Women'S Cancer Care /ID# 276469

Covington, Louisiana, United States

University Medical Center New Orleans /ID# 274755

New Orleans, Louisiana, United States

Trials 365 /ID# 274310

Shreveport, Louisiana, United States

Holy Cross Hospital /ID# 275872

Silver Spring, Maryland, United States

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

Saint Louis Park, Minnesota, United States

Cox Medical Center South /ID# 274826

Springfield, Missouri, United States

The Center Of Hope /ID# 274313

Reno, Nevada, United States

Rutgers Cancer Institute of New Jersey /ID# 274358

New Brunswick, New Jersey, United States

Holy Name Medical Center /ID# 276240

Teaneck, New Jersey, United States

Optimum Clinical Research Group /ID# 274583

Albuquerque, New Mexico, United States

Imbert Cancer Center /ID# 275634

Bay Shore, New York, United States

Northwell Health Cancer Institute At Huntington /ID# 276814

Greenlawn, New York, United States

Northwell Health Center for Advanced Medicine. /ID# 275641

Lake Success, New York, United States

Northwell Health Queens Cancer Center /ID# 274850

Rego Park, New York, United States

University of North Carolina Medical Center /ID# 275307

Chapel Hill, North Carolina, United States

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

Greenville, North Carolina, United States

Sanford Fargo Medical Center - Fargo /ID# 275489

Fargo, North Dakota, United States

The Mark H Zangmeister Center /ID# 275106

Columbus, Ohio, United States

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

Eugene, Oregon, United States

Northwest Cancer Specialists /ID# 275101

Portland, Oregon, United States

St. Lukes University Hospital /ID# 274362

Bethlehem, Pennsylvania, United States

University of Pennsylvania /ID# 275612

Philadelphia, Pennsylvania, United States

Women & Infants Hospital /ID# 274716

Providence, Rhode Island, United States

Sanford Cancer Center /ID# 274901

Sioux Falls, South Dakota, United States

Avera Cancer Institute - Sioux Falls /ID# 276226

Sioux Falls, South Dakota, United States

Texas Oncology - Austin Central /ID# 275046

Austin, Texas, United States

Texas Oncology - Fort Worth Cancer Center /ID# 275043

Fort Worth, Texas, United States

Houston Methodist Hospital /ID# 274568

Houston, Texas, United States

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

San Antonio, Texas, United States

Texas Oncology - The Woodlands /ID# 275015

The Woodlands, Texas, United States

Texas Oncology - Northeast Texas /ID# 275057

Tyler, Texas, United States

UVA Health University Hospital /ID# 275309

Charlottesville, Virginia, United States

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

Fairfax, Virginia, United States

Carilion Clinic Gynecologic Oncology /ID# 274684

Roanoke, Virginia, United States

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

Spokane, Washington, United States

West Virginia University School of Medicine /ID# 274556

Morgantown, West Virginia, United States

Clinical Research Directory

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.

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (50)