RECRUITING

Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

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Conditions

Ovarian CancerPeritoneal CancerFallopian Tube CancerPlatinum-sensitiveFolate-receptor alpha expressionAntibody-drug conjugateCancerOvarian NeoplasmaRecurrent Platinum-SensitiveHigh-Grade OvarianADCAdult

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine + Bevacizumab as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.

Official Title

Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab

Quick Facts

Study Start:2022-12-27
Study Completion:2029-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05445778

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult women \>/=18 years old
  2. 2. Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
  3. 3. Confirmed high FRα expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1)
  4. 4. Relapsed disease after frontline (first-line) platinum-based chemotherapy and must be plantinum-sensitive
  5. 5. Willing and able to sign the informed consent form (ICF) and adhere to protocol requirements
  6. 6. Negative pregnancy test and willing to use highly effective contraceptive method(s) while on study medication and for at least 7 months after the last dose of MIRV and 6 months after the last dose of bevacizumab
  1. 1. Endometrioid, clear cell, mucinous, or sarconmatous histology; mixed tumors containing any of the above or low grade/borderline ovarian tumor
  2. 2. More than one line of prior chemotherapy before current/planned triplet therapy
  3. 3. PD (progressive disease) while on or following platinum-based therapy
  4. 4. Prior or whole-pelvis or wide-field radiotherapy
  5. 5. \> Grade 1 peripheral neuropathy
  6. 6. History of or concurrent ocular disorders
  7. 7. Grade 4 thromboembolic events
  8. 8. Not appropriate for bevacizumab treatment
  9. 9. Requiring use of folate-containing supplements
  10. 10. Prior hypersensitivity to monoclonal antibodies
  11. 11. Pregnant or breatfeeding women
  12. 12. Received prior MIRV or other FRα-targeting agents
  13. 13. Untreated or symptomatic central nervous system metastases
  14. 14. History of other malignancy within 3 years prior to signing study consent

Contacts and Locations

Study Contact

ABBVIE CALL CENTER
CONTACT
844-663-3742
abbvieclinicaltrials@abbvie.com

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

Usa Mitchell Cancer Institute /ID# 269661
Mobile, Alabama, 36604
United States
Honorhealth Virginia G. Piper Cancer Care Network - Biltmore /ID# 269987
Phoenix, Arizona, 85016
United States
City of Hope Orange County Lennar Foundation Cancer Center /ID# 269573
Irvine, California, 92618
United States
Moores Cancer Center at UC San Diego /ID# 269564
La Jolla, California, 92093
United States
University Of California Irvine Medical Center /ID# 269572
Orange, California, 92868
United States
Stanford Women'S Cancer Center /ID# 269552
Palo Alto, California, 94304
United States
Kaiser Permanente Zion Medical Center /ID# 269537
San Diego, California, 92120
United States
Kaiser Permanente - San Diego Medical Center /ID# 269540
San Diego, California, 92123
United States
Kaiser Permanente - San Marcos Medical Offices /ID# 269542
San Marcos, California, 92069
United States
Olive View-Ucla Medical Center /ID# 269584
Sylmar, California, 91342
United States
John Muir Health - Walnut Creek Medical Center /ID# 269575
Walnut Creek, California, 94598
United States
Broward General Medical Center /ID# 269577
Fort Lauderdale, Florida, 33316
United States
Regional Cancer Center /ID# 269558
Fort Myers, Florida, 33905
United States
Baptist Md Anderson Cancer Center - Jacksonville - Palm Avenue /ID# 269560
Jacksonville, Florida, 32207
United States
Mount Sinai Medical Center /ID# 269582
Miami, Florida, 33140
United States
Sarasota Memorial Hospital /ID# 269526
Sarasota, Florida, 34239
United States
Northside Hospital /ID# 269660
Atlanta, Georgia, 30342
United States
Rush University Medical Center /ID# 269583
Chicago, Illinois, 60612
United States
University of Chicago Medical Center /ID# 269546
Chicago, Illinois, 60637
United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 269110
Indianapolis, Indiana, 46202-5116
United States
St. Vincent Indianapolis Hospital /ID# 269107
Indianapolis, Indiana, 46260
United States
University of Iowa /ID# 269566
Iowa City, Iowa, 52242
United States
The University of Kansas Cancer Center - Westwood /ID# 269106
Westwood, Kansas, 66205
United States
Baptist Health Lexington /ID# 269568
Lexington, Kentucky, 40503
United States
University of Kentucky Chandler Medical Center /ID# 269536
Lexington, Kentucky, 40536
United States
Louisiana State University Health Sciences Center - New Orleans /ID# 269559
New Orleans, Louisiana, 70112
United States
Ochsner Medical Center - Jefferson Highway /ID# 269530
New Orleans, Louisiana, 70121
United States
Maine Medical Center - Scarborough Campus /ID# 269555
Scarborough, Maine, 04074
United States
Johns Hopkins Hospital /ID# 269579
Baltimore, Maryland, 21287
United States
Sinai Hospital Of Baltimore /ID# 269567
Manchester, Maryland, 21215
United States
GBMC Cancer Center /ID# 269561
Towson, Maryland, 21204-6831
United States
Tufts Medical Center /ID# 269547
Boston, Massachusetts, 02111-1552
United States
Baystate Medical Center /ID# 269544
Springfield, Massachusetts, 01199
United States
Corewell Health /ID# 269562
Grand Rapids, Michigan, 49503
United States
Minnesota Oncology - Coon Rapids Clinic /ID# 269550
Coon Rapids, Minnesota, 55433
United States
Nebraska Methodist Hospital /ID# 269580
Omaha, Nebraska, 68114
United States
The Center Of Hope /ID# 269528
Reno, Nevada, 89511
United States
Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 269576
Lebanon, New Hampshire, 03756
United States
John Theurer Cancer Center /ID# 269109
Hackensack, New Jersey, 07601
United States
The Valley Hospital /ID# 269548
Paramus, New Jersey, 07652
United States
Holy Name Medical Center /ID# 269543
Teaneck, New Jersey, 07666
United States
New York Oncology Hematology - Albany Cancer Center /ID# 269565
Albany, New York, 12206-5013
United States
Women'S Cancer Care Associates /ID# 269553
Albany, New York, 12208
United States
Northwell Health Center for Advanced Medicine /ID# 269108
Lake Success, New York, 11042
United States
NYU Laura and Isaac Perlmutter Cancer Center /ID# 269556
New York, New York, 10016
United States
Icahn School of Medicine at Mount Sinai /ID# 269529
New York, New York, 10029
United States
University of North Carolina at Chapel Hill /ID# 269563
Chapel Hill, North Carolina, 27514
United States
Duke Cancer Institute /ID# 269557
Durham, North Carolina, 27710
United States
University of Cincinnati /ID# 269578
Cincinnati, Ohio, 45267-2827
United States
The Ohio State University Comprehensive Cancer Center /ID# 269105
Columbus, Ohio, 43210-1240
United States
Kettering Medical Center /ID# 269585
Kettering, Ohio, 45429
United States
Ou Health - Stephenson Cancer Center /ID# 269525
Oklahoma City, Oklahoma, 73104
United States
Oklahoma Cancer Specialists and Research Institute /ID# 269527
Tulsa, Oklahoma, 74146
United States
Willamette Valley Cancer Institute and Research Center /ID# 269988
Eugene, Oregon, 97401
United States
Compass Oncology - Rose Quarter /ID# 270131
Portland, Oregon, 97227
United States
Oregon Health and Science University /ID# 269581
Portland, Oregon, 97239
United States
Magee-Womens Hospital of UPMC /ID# 269659
Pittsburgh, Pennsylvania, 15213-3108
United States
Allegheny Health Network West Penn Hospital /ID# 269551
Pittsburgh, Pennsylvania, 15244
United States
Asplundh Cancer Pavilion /ID# 269574
Willow Grove, Pennsylvania, 19090
United States
Sanford Cancer Center /ID# 269535
Sioux Falls, South Dakota, 57104
United States
West Cancer Center and Research Institute - Germantown /ID# 269569
Germantown, Tennessee, 38138
United States
Texas Oncology - Austin Central /ID# 269531
Austin, Texas, 78731
United States
Texas Oncology - Bedford /ID# 269571
Bedford, Texas, 76022
United States
Texas Oncology - Methodist Dallas Cancer Center /ID# 269554
Dallas, Texas, 75203
United States
Texas Oncology - Fort Worth Cancer Center /ID# 269532
Fort Worth, Texas, 76104
United States
Texas Oncology, P. A. /ID# 269549
San Antonio, Texas, 78240-5251
United States
University of Virginia Health System /ID# 269545
Charlottesville, Virginia, 22908-0816
United States
Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 269533
Norfolk, Virginia, 23502
United States
Vcu Health Adult Outpatient Pavillion /ID# 269570
Richmond, Virginia, 23219
United States
Swedish Cancer Institute /ID# 269538
Seattle, Washington, 98104-3588
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-27
Study Completion Date2029-04

Study Record Updates

Study Start Date2022-12-27
Study Completion Date2029-04

Terms related to this study

Keywords Provided by Researchers

  • Platinum-sensitive
  • Folate-receptor alpha expression
  • Antibody-drug conjugate
  • Cancer
  • Ovarian Neoplasma
  • Recurrent Platinum-Sensitive
  • High-Grade Ovarian
  • ADC
  • Adult

Additional Relevant MeSH Terms

  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer