Actively Recruiting
A Single-Arm Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine for Women With FRb1-Expressing Advanced Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Led by AbbVie · Updated on 2026-05-29
140
Participants Needed
64
Research Sites
N/A
Total Duration
On this page
Sponsors
A
AbbVie
Lead Sponsor
G
GOG Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment using carboplatin and mirvetuximab soravtansine in adult women with advanced-stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that expresses folate receptor alpha (FRb1). This single-arm Phase 2 study focuses on patients with stage III or IV disease who have measurable tumors and high FRb1 expression. The investigational drug mirvetuximab soravtansine is designed to target and kill cancer cells carrying this receptor. Participants will receive intravenous infusions of mirvetuximab soravtansine combined with carboplatin on the first day of each 21-day cycle. Bevacizumab may also be given based on the investigator's decision. This treatment will continue for 6 to 9 cycles over the course of the study, which is expected to last approximately three years. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, and scans to monitor their response to treatment and any side effects. Researchers will evaluate tumor response through imaging and other measures over up to three years, also tracking disease control, progression-free survival, and symptom changes. Safety will be closely monitored throughout the study period.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Diagnosed with biopsy-confirmed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Stage III or IV disease by the FIGO staging system
- Folate Receptor Alpha (FRb1) expression in at least 75% of tumor cells with moderate or higher membrane staining as tested by Ventana FOLR1 assay
- Measurable disease by RECIST Version 1.1 criteria
- Judged by investigator or treating physician to be appropriate for neoadjuvant chemotherapy
You will not qualify if you...
- Tumor types including endometrioid, clear cell, mucinous, sarcomatous histology, mixed tumors containing these types, or low-grade/borderline ovarian tumors
- History of noninfectious interstitial lung disease or pneumonitis
- Prior anticancer therapy for current cancer except one cycle of carboplatin
- Certain eye conditions including history of corneal transplantation, recent or active eye surgeries, severe corneal disease, uncontrolled glaucoma, wet age-related macular degeneration, diabetic retinopathy with macular edema, macular degeneration, papilledema, or risk of retinal detachment
- Monocular vision with visual acuity worse than 20/200 or visual fields less than 20 degrees
- History of other malignancies within 3 years before consent, except for certain low-risk skin or cervical cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Repeated 21-day cycles until completion of planned neoadjuvant chemotherapy
Participants receive carboplatin in combination with mirvetuximab soravtansine intravenously on Day 1 of each 21-day cycle. Bevacizumab may also be given depending on the investigator's discretion.
1 visit per 21-day cycle for infusion
Trial Site Locations
Total: 64 locations
1
University of Alabama at Birmingham (UAB) Hospital /ID# 274793
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Usa Mitchell Cancer Institute /ID# 276022
Mobile, Alabama, United States, 36604
Actively Recruiting
3
University of California Los Angeles Medical Center /ID# 274566
Los Angeles, California, United States, 90095
Actively Recruiting
4
Scripps Md Anderson - Prebys Cancer Center /ID# 276891
San Diego, California, United States, 92103
Actively Recruiting
5
California Pacific Medical Center /ID# 275329
San Francisco, California, United States, 94109
Actively Recruiting
6
Ridley Tree Cancer Center /ID# 275219
Santa Barbara, California, United States, 93105
Active, Not Recruiting
7
Danbury Hospital, Western Connecticut Health Network /ID# 274783
Danbury, Connecticut, United States, 06810
Actively Recruiting
8
Yale University School of Medicine /ID# 275794
New Haven, Connecticut, United States, 06510
Actively Recruiting
9
Norwalk Hospital /ID# 274561
Norwalk, Connecticut, United States, 06856
Actively Recruiting
10
Jupiter Medical Center /ID# 276616
Jupiter, Florida, United States, 33458
Actively Recruiting
11
Mount Sinai Medical Center /ID# 274868
Miami Beach, Florida, United States, 33140
Actively Recruiting
12
Rush Md Anderson Cancer Center /ID# 274926
Chicago, Illinois, United States, 60607
Actively Recruiting
13
OSF St. Francis Medical Center /ID# 274752
Peoria, Illinois, United States, 61637-0001
Actively Recruiting
14
Parkview Research Center /ID# 274338
Fort Wayne, Indiana, United States, 46845
Actively Recruiting
15
Indiana University Melvin and Bren Simon Cancer Center /ID# 275492
Indianapolis, Indiana, United States, 46202
Actively Recruiting
16
Baptist Health Lexington /ID# 275218
Lexington, Kentucky, United States, 40503
Actively Recruiting
17
Norton Cancer Institute - St. Matthews /ID# 276173
Louisville, Kentucky, United States, 40207
Actively Recruiting
18
Women'S Cancer Care /ID# 276469
Covington, Louisiana, United States, 70433
Actively Recruiting
19
University Medical Center New Orleans /ID# 274755
New Orleans, Louisiana, United States, 70112
Actively Recruiting
20
Trials 365 /ID# 274310
Shreveport, Louisiana, United States, 71103
Actively Recruiting
21
University of Maryland, Baltimore /ID# 275308
Baltimore, Maryland, United States, 21201
Actively Recruiting
22
Holy Cross Hospital /ID# 275872
Silver Spring, Maryland, United States, 20910
Actively Recruiting
23
University of Minnesota - Minneapolis /ID# 275718
Minneapolis, Minnesota, United States, 55455-0341
Actively Recruiting
24
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
25
University Of Mississippi Medical Center /ID# 276342
Jackson, Mississippi, United States, 39216
Actively Recruiting
26
Cox Medical Center South /ID# 274826
Springfield, Missouri, United States, 65807
Actively Recruiting
27
Mercy Hospital St. Louis /ID# 275655
St Louis, Missouri, United States, 63141
Actively Recruiting
28
The Center Of Hope /ID# 274313
Reno, Nevada, United States, 89511
Actively Recruiting
29
Dartmouth-Hitchcock Medical Center /ID# 274676
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
30
Rutgers Cancer Institute of New Jersey /ID# 274358
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
31
Holy Name Medical Center /ID# 276240
Teaneck, New Jersey, United States, 07666
Actively Recruiting
32
Optimum Clinical Research Group /ID# 274583
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
33
Imbert Cancer Center /ID# 275634
Bay Shore, New York, United States, 11706
Actively Recruiting
34
Northwell Health Cancer Institute At Huntington /ID# 276814
Greenlawn, New York, United States, 11740
Actively Recruiting
35
Northwell Health Center for Advanced Medicine. /ID# 275641
Lake Success, New York, United States, 11042
Actively Recruiting
36
Northwell Health Queens Cancer Center /ID# 274850
Rego Park, New York, United States, 11374
Actively Recruiting
37
University of North Carolina Medical Center /ID# 275307
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
38
East Carolina University - Brody School of Medicine /ID# 275770
Greenville, North Carolina, United States, 27834
Actively Recruiting
39
Atrium Health Wake Forest Baptist Medical Center /ID# 276952
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
40
Sanford Fargo Medical Center - Fargo /ID# 275489
Fargo, North Dakota, United States, 58102
Actively Recruiting
41
Cleveland Clinic - Cleveland /ID# 276133
Cleveland, Ohio, United States, 44195
Actively Recruiting
42
Cleveland Clinic - Cleveland /ID# 278273
Cleveland, Ohio, United States, 44195
Actively Recruiting
43
Cleveland Clinic - Cleveland /ID# 278274
Cleveland, Ohio, United States, 44195
Actively Recruiting
44
The Mark H Zangmeister Center /ID# 275106
Columbus, Ohio, United States, 43219
Actively Recruiting
45
Kettering Medical Center /ID# 274365
Kettering, Ohio, United States, 45429
Actively Recruiting
46
Oncology Associates of Oregon, P.C. /ID# 275006
Eugene, Oregon, United States, 97401
Actively Recruiting
47
Compass Oncology - West - Tigard /ID# 275101
Tigard, Oregon, United States, 97223
Actively Recruiting
48
St. Lukes University Hospital /ID# 274362
Bethlehem, Pennsylvania, United States, 18015
Actively Recruiting
49
University of Pennsylvania /ID# 275612
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
50
Women & Infants Hospital /ID# 274716
Providence, Rhode Island, United States, 02905
Actively Recruiting
51
Sanford Cancer Center /ID# 274901
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
52
Avera Cancer Institute - Sioux Falls /ID# 276226
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
53
Texas Oncology - Austin Central /ID# 275046
Austin, Texas, United States, 78731
Actively Recruiting
54
Texas Oncology - Fort Worth Cancer Center /ID# 275043
Fort Worth, Texas, United States, 76104
Actively Recruiting
55
Houston Methodist Hospital /ID# 274568
Houston, Texas, United States, 77030
Actively Recruiting
56
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 275090
San Antonio, Texas, United States, 78240
Actively Recruiting
57
Texas Oncology - The Woodlands /ID# 275015
The Woodlands, Texas, United States, 77380
Actively Recruiting
58
Texas Oncology - Northeast Texas /ID# 275057
Tyler, Texas, United States, 75702
Actively Recruiting
59
UVA Health University Hospital /ID# 275309
Charlottesville, Virginia, United States, 22903
Actively Recruiting
60
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 276456
Fairfax, Virginia, United States, 22031
Actively Recruiting
61
Virginia Oncology Associates- Norfolk (Brock) /ID# 275227
Norfolk, Virginia, United States, 23502-2800
Actively Recruiting
62
Carilion Roanoke Memorial Hospital /ID# 274684
Roanoke, Virginia, United States, 24014
Actively Recruiting
63
Providence Sacred Heart Medical Center & Children'S Hospital /ID# 274585
Spokane, Washington, United States, 99204
Actively Recruiting
64
West Virginia University School of Medicine /ID# 274556
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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