A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer
Start Date
11/13/2025
Completion Date
1/1/2029
Summary
Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay. Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 3 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. In substudy 3, arms F and G, participants will receive one of two doses of MIRV with BEV and carboplatin, followed by MIRV with BEV. Approximately 400 participants will be enrolled in the study at 100 sites around the world. Participants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused carboplatin and Bev, or IV infused Bev alone. The total study duration will be approximately 40 months. 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Mirvetuximab Soravtansine
Bevacizumab
Carboplatin
Conditions
Locations
UC San Diego Health - Moores Cancer Center /ID# 277574
La Jolla, California 92037
United States
Sansum Clinic - Solvang /ID# 277712
Solvang, California 93463
United States
University of Florida College of Medicine /ID# 278348
Gainesville, Florida 32610
United States
Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623
Orlando, Florida 32806
United States
Florida Cancer Specialists - North /ID# 278626
St. Petersburg, Florida 33705
United States
Florida Cancer Specialists - East /ID# 278605
West Palm Beach, Florida 33401
United States
Our Lady of the Lake Physician Group - Medical Oncology /ID# 277440
Baton Rouge, Louisiana 70817
United States
Maine Medical Center - Scarborough Campus /ID# 277205
Scarborough, Maine 04074
United States
Karmanos Cancer Institute - Detroit /ID# 277085
Detroit, Michigan 48201
United States
Intermountain Health - Intermountain Health West End Clinic /ID# 278470
Billings, Montana 59106
United States
Md Anderson Cancer Center At Cooper /ID# 278390
Camden, New Jersey 08103
United States
SUNY Upstate Medical University - Syracuse /ID# 277245
Syracuse, New York 13210
United States
FirstHealth of the Carolinas- Speciality Center /ID# 278636
Pinehurst, North Carolina 28374
United States
Jamescare Gynecologic Oncology At Mill Run /ID# 277951
Hilliard, Ohio 43026
United States
Willamette Valley Cancer Institute and Research Center /ID# 277714
Eugene, Oregon 97401
United States
Penn Medicine University of Pennsylvania Health System /ID# 277963
Philadelphia, Pennsylvania 19104
United States
Western Pennsylvania Gynecologic Oncology /ID# 278632
Pittsburgh, Pennsylvania 15224
United States
Avera Cancer Institute - Sioux Falls /ID# 278627
Sioux Falls, South Dakota 57105
United States
University Of Tennessee Medical Center /ID# 278225
Knoxville, Tennessee 37920
United States
Texas Oncology - Abilene - Antilley Road /ID# 277739
Abilene, Texas 79606
United States
Texas Oncology - Fort Worth Cancer Center /ID# 277989
Fort Worth, Texas 76104
United States
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 277735
San Antonio, Texas 78240
United States
Texas Oncology - The Woodlands /ID# 277926
The Woodlands, Texas 77380
United States
Texas Oncology - Northeast Texas /ID# 277737
Tyler, Texas 75702
United States
Virginia Mason Hospital and Medical Center /ID# 277259
Seattle, Washington 98101
United States
West Virginia University Hospitals /ID# 278965
Morgantown, West Virginia 26506
United States
St. George Private Hospital /ID# 276570
Kogarah, New South Wales 2217
Australia
Chris O'Brien Lifehouse /ID# 276337
Sydney, New South Wales 2050
Australia
Icon Cancer Centre Wesley /ID# 277199
Auchenflower, Queensland 4066
Australia
Burnside War Memorial Hospital /ID# 277602
Adelaide, South Australia 5065
Australia
Icon Cancer Centre Hobart /ID# 277688
Hobart, Tasmania 7000
Australia
Monash Health - Monash Medical Centre - Clayton /ID# 276984
Clayton, Victoria 3168
Australia
Barwon Health /ID# 277297
Geelong, Victoria 3220
Australia
Austin Hospital /ID# 276534
Melbourne, Victoria 3084
Australia
Epworth Hospital - Richmond /ID# 276347
Richmond, Victoria 3121
Australia
St. John Of God Subiaco Hospital /ID# 277174
Subiaco, Western Australia 6008
Australia
Cliniques Universitaires UCL Saint-Luc /ID# 276321
Brussels, Brussels Capital 1200
Belgium
AZ Maria Middelares /ID# 276325
Ghent, Oost-Vlaanderen 9000
Belgium
Universitair Ziekenhuis Leuven /ID# 276316
Leuven, Vlaams-Brabant 3000
Belgium
CHU de Liege /ID# 276500
Liège, 4000
Belgium
UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 277183
Namur, 5000
Belgium
Masarykuv Onkologicky Ustav /ID# 276080
Brno, Brno-mesto 656 53
Czechia
Vseobecna Fakultni nemocnice v Praze /ID# 276213
Prague, Praha 17 128 00
Czechia
Fakultni nemocnice Motol a Homolka /ID# 276300
Prague, Praha 5 150 06
Czechia
Fakultni nemocnice Hradec Kralove - Sokolska /ID# 276205
Hradec Králové, 500 05
Czechia
Herlev Hospital /ID# 276831
Herlev, Capital Region 2730
Denmark
Aalborg University Hospital /ID# 276435
Aalborg, North Denmark 9000
Denmark
Odense University Hospital /ID# 276462
Odense, Region Syddanmark 5000
Denmark
Strasbourg Oncologie Liberale /ID# 276698
Strasbourg, Bas-Rhin 67000
France
Centre Georges Francois Leclerc /ID# 276737
Dijon, Bourgogne-Franche-Comté 21079
France
Centre Francois Baclesse /ID# 276709
Caen, Calvados 14076
France
Hopital Prive Des Cotes D'Armor /ID# 276706
Plérin, Cotes-d Armor 22190
France
Institut Bergonie /ID# 276696
Bordeaux, Gironde 33076
France
Institut Curie -Site Saint-Cloud /ID# 276850
Saint-Cloud, Hauts-de-Seine 92210
France
Institut Godinot /ID# 276849
Reims, Marne 51726
France
CHU de Limoges site CHU Dupuytren 1 /ID# 276851
Limoges, New Aquitaine 87000
France
IUCT Oncopole /ID# 276705
Toulouse, Occitanie 31059
France
Centre Antoine-Lacassagne /ID# 276708
Nice, Provence-Alpes-Côte d'Azur Region 06189
France
Centre Leon Berard /ID# 276710
Lyon, Rhone 69373
France
Institut du Cancer Avignon Provence - Sainte Catherine /ID# 276692
Avignon, Vaucluse 84918
France
Institut Gustave Roussy /ID# 276712
Villejuif, Île-de-France Region 94800
France
National Cancer Center /ID# 276283
Goyang-si, Gyeonggido 10408
South Korea
Seoul National University Bundang Hospital /ID# 276280
Seongnam-si, Gyeonggido 13620
South Korea
Seoul National University Hospital /ID# 276182
Seoul, Seoul Teugbyeolsi 03080
South Korea
Yonsei University Health System Severance Hospital /ID# 276266
Seoul, Seoul Teugbyeolsi 03722
South Korea
Asan Medical Center /ID# 276955
Seoul, Seoul Teugbyeolsi 05505
South Korea
Samsung Medical Center /ID# 276261
Seoul, Seoul Teugbyeolsi 06351
South Korea
Korea University Guro Hospital /ID# 276194
Seoul, Seoul Teugbyeolsi 08308
South Korea
Hospital Universitario Marques de Valdecilla /ID# 276415
Santander, Cantabria 39008
Spain
Hospital Universitario Donostia /ID# 276404
Donostia / San Sebastian, Guipuzcoa 20014
Spain
Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria /ID# 276438
Las Palmas de Gran Canaria, Las Palmas 35016
Spain
Hospital Universitario Virgen del Rocio /ID# 276426
Seville, Sevilla 41013
Spain
Complejo Hospitalario Universitario A Coruna /ID# 276416
A Coruña, 15006
Spain
Hospital Universitari Vall d Hebron /ID# 276478
Barcelona, 08035
Spain
Hospital Clinic de Barcelona /ID# 276412
Barcelona, 08036
Spain
Institut Catala D Oncologia - Ico - Girona /ID# 276410
Girona, 17007
Spain
Clinica Universidad de Navarra - Madrid /ID# 276411
Madrid, 28027
Spain
Hospital Clinico San Carlos. /ID# 276407
Madrid, 28040
Spain
Instituto Valenciano de Oncologia /ID# 276413
Valencia, 46009
Spain
Hospital Clinico Universitario Lozano Blesa /ID# 276406
Zaragoza, 50009
Spain