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

Status: Recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham (UAB) Hospital /ID# 274793
RECRUITING
Birmingham
California
California Pacific Medical Center /ID# 275329
RECRUITING
San Francisco
Ridley Tree Cancer Center /ID# 275219
RECRUITING
Santa Barbara
Connecticut
Danbury Hospital, Western Connecticut Health Network /ID# 274783
RECRUITING
Danbury
Norwalk Hospital /ID# 274561
RECRUITING
Norwalk
Florida
Jupiter Medical Center /ID# 276616
RECRUITING
Jupiter
Mount Sinai Medical Center /ID# 274868
RECRUITING
Miami
Illinois
OSF St. Francis Medical Center /ID# 274752
RECRUITING
Peoria
Louisiana
Women'S Cancer Care /ID# 276469
RECRUITING
Covington
University Medical Center New Orleans /ID# 274755
RECRUITING
New Orleans
Trials 365 /ID# 274310
RECRUITING
Shreveport
Minnesota
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780
RECRUITING
Saint Louis Park
Missouri
Cox Medical Center South /ID# 274826
RECRUITING
Springfield
North Carolina
University of North Carolina Medical Center /ID# 275307
RECRUITING
Chapel Hill
New Jersey
Rutgers Cancer Institute of New Jersey /ID# 274358
RECRUITING
New Brunswick
Nevada
The Center Of Hope /ID# 274313
RECRUITING
Reno
New York
Imbert Cancer Center /ID# 275634
RECRUITING
Bay Shore
Northwell Health Cancer Institute At Huntington /ID# 276814
RECRUITING
Greenlawn
Northwell Health Center for Advanced Medicine. /ID# 275641
RECRUITING
Lake Success
Northwell Health Queens Cancer Center /ID# 274850
RECRUITING
Rego Park
Ohio
The Mark H Zangmeister Center /ID# 275106
RECRUITING
Columbus
Oregon
Oncology Associates of Oregon, P.C. /ID# 275006
RECRUITING
Eugene
Northwest Cancer Specialists /ID# 275101
RECRUITING
Portland
Pennsylvania
St. Lukes University Hospital /ID# 274362
RECRUITING
Bethlehem
University of Pennsylvania /ID# 275612
RECRUITING
Philadelphia
Rhode Island
Women & Infants Hospital /ID# 274716
RECRUITING
Providence
Texas
Texas Oncology - Austin Central /ID# 275046
RECRUITING
Austin
Houston Methodist Hospital /ID# 274568
RECRUITING
Houston
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 275090
RECRUITING
San Antonio
Texas Oncology - The Woodlands /ID# 275015
RECRUITING
The Woodlands
Texas Oncology - Northeast Texas /ID# 275057
RECRUITING
Tyler
Virginia
UVA Health University Hospital /ID# 275309
RECRUITING
Charlottesville
Carilion Clinic /ID# 274684
RECRUITING
Roanoke
Washington
Providence Sacred Heart Medical Center & Children'S Hospital /ID# 274585
RECRUITING
Spokane
West Virginia
West Virginia University School of Medicine /ID# 274556
RECRUITING
Morgantown
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-11-21
Estimated Completion Date: 2030-02
Participants
Target number of participants: 140
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: AbbVie
Collaborators: GOG Foundation

This content was sourced from clinicaltrials.gov

Similar Clinical Trials