Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06890338

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.

Led by AbbVie · Updated on 2026-05-13

140

Participants Needed

61

Research Sites

219 weeks

Total Duration

On this page

Sponsors

A

AbbVie

Lead Sponsor

G

GOG Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official 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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants aged 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Appropriate candidate for neoadjuvant chemotherapy as judged by investigator or treating physician
  • 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 (FRα) expression positive, defined as ≥75% of viable tumor cells with moderate (≥2+) membrane staining
  • Measurable disease by RECIST Version 1.1 criteria
Not Eligible

You will not qualify if you...

  • Tumors with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing these histologies, or low-grade/borderline ovarian tumors
  • Previous diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis
  • Prior anticancer therapy for current cancer, except one cycle of single agent carboplatin
  • History of corneal transplantation
  • Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or related complications
  • Confluent superficial punctate keratopathy not expected to improve before screening
  • Active or chronic clinically significant (≥ Grade 3) corneal dystrophy
  • Active ocular conditions needing ongoing treatment or monitoring, including uncontrolled glaucoma, wet age-related macular degeneration requiring injections, active diabetic retinopathy with macular edema, macular degeneration, papilledema, or high 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 prior to consent, except tumors with negligible risk for metastasis or death such as controlled basal-cell carcinoma, squamous-cell carcinoma of skin, or carcinoma in situ of cervix or breast

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 61 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 Mercy Hospital /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

Actively 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, 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

Cox Medical Center South /ID# 274826

Springfield, Missouri, United States, 65807

Actively Recruiting

26

The Center Of Hope /ID# 274313

Reno, Nevada, United States, 89511

Actively Recruiting

27

Dartmouth-Hitchcock Medical Center /ID# 274676

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

28

Rutgers Cancer Institute of New Jersey /ID# 274358

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

29

Holy Name Medical Center /ID# 276240

Teaneck, New Jersey, United States, 07666

Actively Recruiting

30

Optimum Clinical Research Group /ID# 274583

Albuquerque, New Mexico, United States, 87109

Actively Recruiting

31

Imbert Cancer Center /ID# 275634

Bay Shore, New York, United States, 11706

Actively Recruiting

32

Northwell Health Cancer Institute At Huntington /ID# 276814

Greenlawn, New York, United States, 11740

Actively Recruiting

33

Northwell Health Center for Advanced Medicine. /ID# 275641

Lake Success, New York, United States, 11042

Actively Recruiting

34

Northwell Health Queens Cancer Center /ID# 274850

Rego Park, New York, United States, 11374

Actively Recruiting

35

University of North Carolina Medical Center /ID# 275307

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

36

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

Greenville, North Carolina, United States, 27834

Actively Recruiting

37

Atrium Health Wake Forest Baptist Medical Center /ID# 276952

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

38

Sanford Fargo Medical Center - Fargo /ID# 275489

Fargo, North Dakota, United States, 58102

Actively Recruiting

39

Cleveland Clinic - Cleveland /ID# 276133

Cleveland, Ohio, United States, 44195

Actively Recruiting

40

Cleveland Clinic - Cleveland /ID# 278273

Cleveland, Ohio, United States, 44195

Actively Recruiting

41

Cleveland Clinic - Cleveland /ID# 278274

Cleveland, Ohio, United States, 44195

Actively Recruiting

42

The Mark H Zangmeister Center /ID# 275106

Columbus, Ohio, United States, 43219

Actively Recruiting

43

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

Eugene, Oregon, United States, 97401

Actively Recruiting

44

Northwest Cancer Specialists /ID# 275101

Portland, Oregon, United States, 97227-1800

Actively Recruiting

45

St. Lukes University Hospital /ID# 274362

Bethlehem, Pennsylvania, United States, 18015

Actively Recruiting

46

University of Pennsylvania /ID# 275612

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

47

Women & Infants Hospital /ID# 274716

Providence, Rhode Island, United States, 02905

Actively Recruiting

48

Sanford Cancer Center /ID# 274901

Sioux Falls, South Dakota, United States, 57104

Actively Recruiting

49

Avera Cancer Institute - Sioux Falls /ID# 276226

Sioux Falls, South Dakota, United States, 57105

Actively Recruiting

50

Texas Oncology - Austin Central /ID# 275046

Austin, Texas, United States, 78731

Actively Recruiting

51

Texas Oncology - Fort Worth Cancer Center /ID# 275043

Fort Worth, Texas, United States, 76104

Actively Recruiting

52

Houston Methodist Hospital /ID# 274568

Houston, Texas, United States, 77030

Actively Recruiting

53

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

San Antonio, Texas, United States, 78240

Actively Recruiting

54

Texas Oncology - The Woodlands /ID# 275015

The Woodlands, Texas, United States, 77380

Actively Recruiting

55

Texas Oncology - Northeast Texas /ID# 275057

Tyler, Texas, United States, 75702

Actively Recruiting

56

UVA Health University Hospital /ID# 275309

Charlottesville, Virginia, United States, 22903

Actively Recruiting

57

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

Fairfax, Virginia, United States, 22031

Actively Recruiting

58

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

Norfolk, Virginia, United States, 23502-2800

Actively Recruiting

59

Carilion Roanoke Memorial Hospital /ID# 274684

Roanoke, Virginia, United States, 24014

Actively Recruiting

60

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

Spokane, Washington, United States, 99204

Actively Recruiting

61

West Virginia University School of Medicine /ID# 274556

Morgantown, West Virginia, United States, 26506

Actively Recruiting

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Research Team

A

ABBVIE CALL CENTER

CONTACT

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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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. | DecenTrialz