Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Purpose
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.
Conditions
- Ovarian Cancer
- Peritoneal Cancer
- Fallopian Tube Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adult women >/=18 years old 2. Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer 3. Confirmed high FRα expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1) 4. Relapsed disease after frontline (first-line) platinum-based chemotherapy and must be plantinum-sensitive 5. Willing and able to sign the informed consent form (ICF) and adhere to protocol requirements 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
Exclusion Criteria
- Endometrioid, clear cell, mucinous, or sarconmatous histology; mixed tumors containing any of the above or low grade/borderline ovarian tumor 2. More than one line of prior chemotherapy before current/planned triplet therapy 3. PD (progressive disease) while on or following platinum-based therapy 4. Prior or whole-pelvis or wide-field radiotherapy 5. > Grade 1 peripheral neuropathy 6. History of or concurrent ocular disorders 7. Grade 4 thromboembolic events 8. Not appropriate for bevacizumab treatment 9. Requiring use of folate-containing supplements 10. Prior hypersensitivity to monoclonal antibodies 11. Pregnant or breatfeeding women 12. Received prior MIRV or other FRα-targeting agents 13. Untreated or symptomatic central nervous system metastases 14. History of other malignancy within 3 years prior to signing study consent
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm 1 |
Mirvetuximab Soravtansine (MIRV) plus Bevacizumab |
|
|
Active Comparator Arm 2 |
Bevacizumab monotherapy |
|
Recruiting Locations
Usa Mitchell Cancer Institute /ID# 269661
Mobile 4076598, Alabama 4829764 36604
Mobile 4076598, Alabama 4829764 36604
Honorhealth Virginia G. Piper Cancer Care Network - Biltmore /ID# 269987
Phoenix 5308655, Arizona 5551752 85016
Phoenix 5308655, Arizona 5551752 85016
Moores Cancer Center at UC San Diego /ID# 269564
La Jolla 5363943, California 5332921 92093
La Jolla 5363943, California 5332921 92093
University Of California Irvine Medical Center /ID# 269572
Orange 5379513, California 5332921 92868
Orange 5379513, California 5332921 92868
Kaiser Permanente Zion Medical Center /ID# 269537
San Diego 5391811, California 5332921 92120
San Diego 5391811, California 5332921 92120
Kaiser Permanente - San Diego Medical Center /ID# 269540
San Diego 5391811, California 5332921 92123
San Diego 5391811, California 5332921 92123
Kaiser Permanente - San Marcos Medical Offices /ID# 269542
San Marcos 5392368, California 5332921 92069
San Marcos 5392368, California 5332921 92069
Olive View-Ucla Medical Center /ID# 269584
Sylmar 5400784, California 5332921 91342
Sylmar 5400784, California 5332921 91342
John Muir Health - Walnut Creek Medical Center /ID# 269575
Walnut Creek 5406990, California 5332921 94598
Walnut Creek 5406990, California 5332921 94598
Broward General Medical Center /ID# 269577
Fort Lauderdale 4155966, Florida 4155751 33316
Fort Lauderdale 4155966, Florida 4155751 33316
Baptist Md Anderson Cancer Center - Jacksonville - Palm Avenue /ID# 269560
Jacksonville 4160021, Florida 4155751 32207
Jacksonville 4160021, Florida 4155751 32207
Mount Sinai Medical Center /ID# 269582
Miami 4164138, Florida 4155751 33140
Miami 4164138, Florida 4155751 33140
Sarasota Memorial Hospital /ID# 269526
Sarasota 4172131, Florida 4155751 34239
Sarasota 4172131, Florida 4155751 34239
Northside Hospital /ID# 269660
Atlanta 4180439, Georgia 4197000 30342
Atlanta 4180439, Georgia 4197000 30342
Rush University Medical Center /ID# 269583
Chicago 4887398, Illinois 4896861 60612
Chicago 4887398, Illinois 4896861 60612
University of Chicago Medical Center /ID# 269546
Chicago 4887398, Illinois 4896861 60637
Chicago 4887398, Illinois 4896861 60637
Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 269110
Indianapolis 4259418, Indiana 4921868 46202-5116
Indianapolis 4259418, Indiana 4921868 46202-5116
St. Vincent Indianapolis Hospital /ID# 269107
Indianapolis 4259418, Indiana 4921868 46260
Indianapolis 4259418, Indiana 4921868 46260
University of Iowa /ID# 269566
Iowa City 4862034, Iowa 4862182 52242
Iowa City 4862034, Iowa 4862182 52242
The University of Kansas Cancer Center - Westwood /ID# 269106
Westwood 4281639, Kansas 4273857 66205
Westwood 4281639, Kansas 4273857 66205
Baptist Health Lexington /ID# 269568
Lexington 4297983, Kentucky 6254925 40503
Lexington 4297983, Kentucky 6254925 40503
Louisiana State University Health Sciences Center - New Orleans /ID# 269559
New Orleans 4335045, Louisiana 4331987 70112
New Orleans 4335045, Louisiana 4331987 70112
Ochsner Medical Center - Jefferson Highway /ID# 269530
New Orleans 4335045, Louisiana 4331987 70121
New Orleans 4335045, Louisiana 4331987 70121
Maine Medical Center - Scarborough Campus /ID# 269555
Scarborough 4977882, Maine 4971068 04074
Scarborough 4977882, Maine 4971068 04074
Johns Hopkins Hospital /ID# 269579
Baltimore 4347778, Maryland 4361885 21287
Baltimore 4347778, Maryland 4361885 21287
Sinai Hospital Of Baltimore /ID# 269567
Manchester 4361547, Maryland 4361885 21215
Manchester 4361547, Maryland 4361885 21215
GBMC Cancer Center /ID# 269561
Towson 4371582, Maryland 4361885 21204-6831
Towson 4371582, Maryland 4361885 21204-6831
Tufts Medical Center /ID# 269547
Boston 4930956, Massachusetts 6254926 02111-1552
Boston 4930956, Massachusetts 6254926 02111-1552
Baystate Medical Center /ID# 269544
Springfield 4951788, Massachusetts 6254926 01199
Springfield 4951788, Massachusetts 6254926 01199
Corewell Health /ID# 269562
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
Minnesota Oncology - Coon Rapids Clinic /ID# 269550
Coon Rapids 5022025, Minnesota 5037779 55433
Coon Rapids 5022025, Minnesota 5037779 55433
Nebraska Methodist Hospital /ID# 269580
Omaha 5074472, Nebraska 5073708 68114
Omaha 5074472, Nebraska 5073708 68114
The Center Of Hope /ID# 269528
Reno 5511077, Nevada 5509151 89511
Reno 5511077, Nevada 5509151 89511
Dartmouth-Hitchcock Medical Center /ID# 269576
Lebanon 5088597, New Hampshire 5090174 03756
Lebanon 5088597, New Hampshire 5090174 03756
John Theurer Cancer Center /ID# 269109
Hackensack 5098706, New Jersey 5101760 07601
Hackensack 5098706, New Jersey 5101760 07601
The Valley Hospital /ID# 269548
Paramus 5102387, New Jersey 5101760 07652
Paramus 5102387, New Jersey 5101760 07652
Holy Name Medical Center /ID# 269543
Teaneck 5105262, New Jersey 5101760 07666
Teaneck 5105262, New Jersey 5101760 07666
Women'S Cancer Care Associates /ID# 269553
Albany 5106834, New York 5128638 12208
Albany 5106834, New York 5128638 12208
Northwell Health Center for Advanced Medicine /ID# 269108
Lake Success 5123853, New York 5128638 11042
Lake Success 5123853, New York 5128638 11042
NYU Laura and Isaac Perlmutter Cancer Center /ID# 269556
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10016
Icahn School of Medicine at Mount Sinai /ID# 269529
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10029
University of North Carolina at Chapel Hill /ID# 269563
Chapel Hill 4460162, North Carolina 4482348 27514
Chapel Hill 4460162, North Carolina 4482348 27514
Duke Cancer Institute /ID# 269557
Durham 4464368, North Carolina 4482348 27710
Durham 4464368, North Carolina 4482348 27710
University of Cincinnati /ID# 269578
Cincinnati 4508722, Ohio 5165418 45267-2827
Cincinnati 4508722, Ohio 5165418 45267-2827
The Ohio State University Comprehensive Cancer Center /ID# 269105
Columbus 4509177, Ohio 5165418 43210-1240
Columbus 4509177, Ohio 5165418 43210-1240
Kettering Medical Center /ID# 269585
Kettering 4515843, Ohio 5165418 45429
Kettering 4515843, Ohio 5165418 45429
Ou Health - Stephenson Cancer Center /ID# 269525
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma Cancer Specialists and Research Institute /ID# 269527
Tulsa 4553433, Oklahoma 4544379 74146
Tulsa 4553433, Oklahoma 4544379 74146
Willamette Valley Cancer Institute and Research Center /ID# 269988
Eugene 5725846, Oregon 5744337 97401
Eugene 5725846, Oregon 5744337 97401
Compass Oncology - Rose Quarter /ID# 270131
Portland 5746545, Oregon 5744337 97227
Portland 5746545, Oregon 5744337 97227
Oregon Health and Science University /ID# 269581
Portland 5746545, Oregon 5744337 97239
Portland 5746545, Oregon 5744337 97239
University Of Pittsburgh Medical Center Magee - Womens Hospital /ID# 269659
Pittsburgh 5206379, Pennsylvania 6254927 15213
Pittsburgh 5206379, Pennsylvania 6254927 15213
Allegheny Health Network West Penn Hospital /ID# 269551
Pittsburgh 5206379, Pennsylvania 6254927 15244
Pittsburgh 5206379, Pennsylvania 6254927 15244
Asplundh Cancer Pavilion /ID# 269574
Willow Grove 5219619, Pennsylvania 6254927 19090
Willow Grove 5219619, Pennsylvania 6254927 19090
Sanford Cancer Center /ID# 269535
Sioux Falls 5231851, South Dakota 5769223 57104
Sioux Falls 5231851, South Dakota 5769223 57104
West Cancer Center and Research Institute - Germantown /ID# 269569
Germantown 4624601, Tennessee 4662168 38138
Germantown 4624601, Tennessee 4662168 38138
Texas Oncology - Austin Central /ID# 269531
Austin 4671654, Texas 4736286 78731
Austin 4671654, Texas 4736286 78731
Texas Oncology - Bedford /ID# 269571
Bedford 4673094, Texas 4736286 76022
Bedford 4673094, Texas 4736286 76022
Texas Oncology - Methodist Dallas Cancer Center /ID# 269554
Dallas 4684888, Texas 4736286 75203
Dallas 4684888, Texas 4736286 75203
Texas Oncology - Fort Worth Cancer Center /ID# 269532
Fort Worth 4691930, Texas 4736286 76104
Fort Worth 4691930, Texas 4736286 76104
US Oncology Research Investigational Products Center /ID# 278746
Irving 4700168, Texas 4736286 75063
Irving 4700168, Texas 4736286 75063
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 269549
San Antonio 4726206, Texas 4736286 78240
San Antonio 4726206, Texas 4736286 78240
University of Virginia Health System /ID# 269545
Charlottesville 4752031, Virginia 6254928 22908-0816
Charlottesville 4752031, Virginia 6254928 22908-0816
Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 269533
Norfolk 4776222, Virginia 6254928 23502
Norfolk 4776222, Virginia 6254928 23502
VCU Health Adult Outpatient Pavillion /ID# 269570
Richmond 4781708, Virginia 6254928 23219
Richmond 4781708, Virginia 6254928 23219
Swedish Cancer Institute /ID# 269538
Seattle 5809844, Washington 5815135 98104-3588
Seattle 5809844, Washington 5815135 98104-3588
More Details
- NCT ID
- NCT05445778
- Status
- Recruiting
- Sponsor
- AbbVie
Detailed Description
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 the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients must have confirmation of FRα positivity by the Ventana FOLR1 Assay.