Epithelial Ovarian CancerPhase 2NCT06890338
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.
A Phase 2 study testing Carboplatin, Mirvetuximab Soravtansine and Bevacizumab in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by AbbVie at 73 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- Carboplatin, Mirvetuximab Soravtansine and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 73 sitesUnited States
- Study dates
- 21 Nov 2025to Feb 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
73 sites in 1 country. Contact the study team or a site near you to ask about taking part.
73 sites in 1 country
United States73 sites, 71 recruiting
- Recruiting
Optimum Clinical Research Group /ID# 274583
Albuquerque, New Mexico, 87109
- Recruiting
Texas Oncology - Austin Central /ID# 275046
Austin, Texas, 78731
- Recruiting
University of Maryland, Baltimore /ID# 275308
Baltimore, Maryland, 21201
- Recruiting
Imbert Cancer Center /ID# 275634
Bay Shore, New York, 11706
- Recruiting
St. Lukes University Hospital /ID# 274362
Bethlehem, Pennsylvania, 18015
- Recruiting
University of Alabama at Birmingham (UAB) Hospital /ID# 274793
Birmingham, Alabama, 35294
- Recruiting
University of North Carolina Medical Center /ID# 275307
Chapel Hill, North Carolina, 27514
- Recruiting
Atrium Health Levine Cancer Institute /ID# 274557
Charlotte, North Carolina, 28204
- Recruiting
UVA Health University Hospital /ID# 275309
Charlottesville, Virginia, 22903
- Recruiting
Rush Md Anderson Cancer Center /ID# 274926
Chicago, Illinois, 60607
- Recruiting
University of Chicago Medical Center /ID# 274796
Chicago, Illinois, 60637
- Recruiting
Metrohealth Medical Center - Cleveland /ID# 276664
Cleveland, Ohio, 44109
- Recruiting
Cleveland Clinic - Cleveland /ID# 276133
Cleveland, Ohio, 44195
- Recruiting
Cleveland Clinic - Cleveland /ID# 278273
Cleveland, Ohio, 44195
- Recruiting
Cleveland Clinic - Cleveland /ID# 278274
Cleveland, Ohio, 44195
- Recruiting
The Mark H Zangmeister Center /ID# 275106
Columbus, Ohio, 43219
- Recruiting
Women'S Cancer Care /ID# 276469
Covington, Louisiana, 70433
- Recruiting
Danbury Hospital, Western Connecticut Health Network /ID# 274783
Danbury, Connecticut, 06810
- Recruiting
Oncology Associates of Oregon, P.C. /ID# 275006
Eugene, Oregon, 97401
- Recruiting
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 276456
Fairfax, Virginia, 22031
- Recruiting
Sanford Fargo Medical Center - Fargo /ID# 275489
Fargo, North Dakota, 58102
- Recruiting
Parkview Research Center /ID# 274338
Fort Wayne, Indiana, 46845
- Recruiting
Texas Oncology - Fort Worth Cancer Center /ID# 275043
Fort Worth, Texas, 76104
- Recruiting
Northwell Health Cancer Institute At Huntington /ID# 276814
Greenlawn, New York, 11740
- Recruiting
East Carolina University - Brody School of Medicine /ID# 275770
Greenville, North Carolina, 27834
- Recruiting
John Theurer Cancer Center /ID# 275756
Hackensack, New Jersey, 07601
- Recruiting
Houston Methodist Hospital /ID# 274568
Houston, Texas, 77030
Site Coordinator, 713.441.3250
- Recruiting
Indiana University Melvin and Bren Simon Cancer Center /ID# 275492
Indianapolis, Indiana, 46202
- Recruiting
Kaiser Permanente - Irvine /ID# 276924
Irvine, California, 92618
- Recruiting
University Of Mississippi Medical Center /ID# 276342
Jackson, Mississippi, 39216
- Recruiting
Jupiter Medical Center /ID# 276616
Jupiter, Florida, 33458
- Recruiting
Kettering Medical Center /ID# 274365
Kettering, Ohio, 45429
- Recruiting
Northwell Health Center for Advanced Medicine. /ID# 275641
Lake Success, New York, 11042
- Recruiting
Dartmouth-Hitchcock Medical Center /ID# 274676
Lebanon, New Hampshire, 03756
- Recruiting
Baptist Health Lexington /ID# 275218
Lexington, Kentucky, 40503
- Recruiting
UCLA - University of California Los Angeles Medical Center /ID# 274566
Los Angeles, California, 90095
- Recruiting
Norton Cancer Institute - St. Matthews /ID# 276173
Louisville, Kentucky, 40207
- Completed
Mount Sinai Medical Center /ID# 274868
Miami Beach, Florida, 33140
- Recruiting
University of Minnesota - Minneapolis /ID# 275718
Minneapolis, Minnesota, 55455-0341
- Recruiting
Usa Mitchell Cancer Institute /ID# 276022
Mobile, Alabama, 36604
- Recruiting
West Virginia University School of Medicine /ID# 274556
Morgantown, West Virginia, 26506
- Recruiting
Rutgers Cancer Institute of New Jersey /ID# 274358
New Brunswick, New Jersey, 08901
- Recruiting
Yale University School of Medicine /ID# 275794
New Haven, Connecticut, 06510
- Recruiting
University Medical Center New Orleans /ID# 274755
New Orleans, Louisiana, 70112
- Recruiting
Columbia University Irving Medical Center /ID# 276156
New York, New York, 10032
- Recruiting
Virginia Oncology Associates- Norfolk (Brock) /ID# 275227
Norfolk, Virginia, 23502-2800
- Recruiting
Norwalk Hospital /ID# 274561
Norwalk, Connecticut, 06856
- Recruiting
OSF St. Francis Medical Center /ID# 274752
Peoria, Illinois, 61637-0001
- Recruiting
University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 275612
Philadelphia, Pennsylvania, 19104
- Recruiting
West Penn Hospital /ID# 276028
Pittsburgh, Pennsylvania, 15224
- Recruiting
Women & Infants Hospital /ID# 274716
Providence, Rhode Island, 02905
- Recruiting
Northwell Health Queens Cancer Center /ID# 274850
Rego Park, New York, 11374
- Recruiting
The Center Of Hope /ID# 274313
Reno, Nevada, 89511
- Recruiting
Carilion Roanoke Memorial Hospital /ID# 274684
Roanoke, Virginia, 24014
- Recruiting
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780
Saint Louis Park, Minnesota, 55416
- Recruiting
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 275090
San Antonio, Texas, 78240
- Recruiting
Scripps Md Anderson - Prebys Cancer Center /ID# 276891
San Diego, California, 92103
- Recruiting
California Pacific Medical Center - Van Ness Campus /ID# 275329
San Francisco, California, 94109
- Active, not recruiting
Ridley Tree Cancer Center /ID# 275219
Santa Barbara, California, 93105
- Recruiting
Willis-Knighton Medical Center /ID# 274310
Shreveport, Louisiana, 71103
- Recruiting
Holy Cross Hospital /ID# 275872
Silver Spring, Maryland, 20910
- Recruiting
Sanford Cancer Center /ID# 274901
Sioux Falls, South Dakota, 57104
- Recruiting
Avera Cancer Institute - Sioux Falls /ID# 276226
Sioux Falls, South Dakota, 57105
- Recruiting
Providence Sacred Heart Medical Center & Children'S Hospital /ID# 274585
Spokane, Washington, 99204
- Recruiting
Cox Medical Center South /ID# 274826
Springfield, Missouri, 65807
- Recruiting
Mercy David C. Pratt Cancer Center /ID# 275655
St Louis, Missouri, 63141
- Recruiting
Holy Name Medical Center /ID# 276240
Teaneck, New Jersey, 07666
- Recruiting
Texas Oncology - The Woodlands /ID# 275015
The Woodlands, Texas, 77380
- Recruiting
Compass Oncology - West - Tigard /ID# 275101
Tigard, Oregon, 97223
Site Coordinator, (971) 708-7600
- Recruiting
Texas Oncology - Northeast Texas /ID# 275057
Tyler, Texas, 75702
- Recruiting
Carle Foundation Hospital /ID# 276470
Urbana, Illinois, 61801
- Recruiting
Good Samaritan Hospital Medical Center /ID# 274938
West Islip, New York, 11795
- Recruiting
Atrium Health Wake Forest Baptist Medical Center /ID# 276952
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read more
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.
- Being tested
- Carboplatin, Mirvetuximab Soravtansine, Bevacizumab
- Keywords
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Neoadjuvant, Interval Debulking Surgery, Mirvetuximab Soravtansine, MIRV, IMGN853, ELAHERE(R), Carboplatin, Bevacizumab
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Intravenous (IV) infusion
Mirvetuximab SoravtansineDrug
Also called MIRV, IMGN853, ELAHERE™
Intravenous (IV) infusion
BevacizumabDrug
Intravenous (IV) infusion (per investigator's discretion)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Carboplatin; Drug: Mirvetuximab Soravtansine; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to Approximately 3 years
Secondary outcomes (11)
Percentage of Participants with Adverse Events (AE)
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.
Measured: Up to Approximately 3 years
Percentage of Participants with AEs leading to study drug discontinuation or dose modification
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.
Measured: Up to Approximately 3 years
Objective Response (OR) by Investigator
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.
Measured: Up to Approximately 3 years
Disease Control by ICR
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.
Measured: Up to Approximately 3 years
Disease control by Investigator
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.
Measured: Up to Approximately 3 years
Percentage of Participants With CA-125 Confirmed Response Per Gynecologic Cancer Intergroup (GCIG) Criteria
The GCIG CA-125 response was defined as at least 50% reduction in CA-125.
Measured: Up to Approximately 3 years
Progression-Free Survival (PFS) by investigator
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.
Measured: Up to Approximately 3 years
Percentage of Participants that Underwent Interval debulking surgery (IDS)
Percentage of participants that underwent IDS during the course of the study treatment
Measured: Up to Approximately 3 years
Percentage of participants with complete tumor cytoreduction at IDS
Complete tumor cytoreduction is defined as the absence of macroscopically visible residual disease at the end of the surgery
Measured: Up to Approximately 3 years
Percentage of participants with Incomplete Tumor Cytoreduction at IDS
Defined as macroscopically visible residual tumor (≤ 1 cm or > 1cm) at the end of surgery.
Measured: 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)
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).
Measured: Up to Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start21 Nov 2025
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GOG Foundation
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890338
- Sponsor's protocol ID
- M25-231
- Other IDs
- GOG-3115
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.