A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine
Start Date
5/28/2025
Completion Date
4/1/2028
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 for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα). 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). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide. The total study duration will be approximately 24 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
Conditions
Locations
First Physicians Group /ID# 272180
Sarasota, Florida 34239
United States
St. Elizabeth Medical Center - Edgewood /ID# 272113
Edgewood, Kentucky 41017
United States
Baptist Health Lexington /ID# 272211
Lexington, Kentucky 40503
United States
UMass Memorial Medical Center - Belmont Street /ID# 272122
Worcester, Massachusetts 01605
United States
Karmanos Cancer Institute - Detroit /ID# 272112
Detroit, Michigan 48201
United States
Allegheny Health Network West Penn Hospital /ID# 272267
Pittsburgh, Pennsylvania 15244
United States
Memorial Hermann Texas Medical Center /ID# 272227
Houston, Texas 77030
United States
Blacktown Hospital /ID# 272182
Blacktown, New South Wales 2148
Australia
Newcastle Private Hosptial /ID# 272213
Lambton Heights, New South Wales 2305
Australia
Royal Brisbane and Women's Hospital /ID# 272123
Brisbane, Queensland 4029
Australia
Icon Cancer Centre Chermside /ID# 272220
Chermside, Queensland 4032
Australia
Ballarat Base Hospital /ID# 272240
Ballarat, Victoria 3350
Australia
Monash Health - Monash Medical Centre - Clayton /ID# 272234
Clayton, Victoria 3168
Australia
Sir Charles Gairdner Hospital /ID# 272116
Nedlands, Western Australia 6009
Australia
Algemeen Ziekenhuis klina /ID# 272127
Brasschaat, Antwerpen 2930
Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 272219
Brussels, Brussels Capital 1200
Belgium
AZ Maria Middelares /ID# 272186
Ghent, Oost-Vlaanderen 9000
Belgium
Universitair Ziekenhuis Leuven /ID# 277350
Leuven, Vlaams-Brabant 3000
Belgium
AZ-Delta /ID# 272250
Roeselare, West-Vlaanderen 8800
Belgium
Centre Francois Baclesse /ID# 272204
Caen, Calvados 14076
France
Centre Armoricain De Radiothérapie, D'Imagerie Médicale Et D'Oncologie (Cario) /ID# 272201
Plérin, Cotes-d Armor 22190
France
Institut De Cancérologie De Lorraine Alexis Vautrin /ID# 272147
Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54519
France
Centre Oscar Lambret /ID# 272183
Lille, Nord 59000
France
Centre Antoine-Lacassagne /ID# 272101
Nice, Provence-Alpes-Côte d'Azur Region 06189
France
HCL - Hopital Lyon Sud /ID# 272178
Pierre-Bénite, Rhone 69495
France
Centre Hospitalier Departemental Vendee (Chd Vendee) /ID# 272174
La Roche-sur-Yon, Vendee 85925
France
GH Diaconesses Croix Saint Simon-Hopital De La Croix Saint-Simon /ID# 272179
Paris, 75020
France
Mazowiecki Szpital Wojewodzki im. Sw. Jana Pawla II w Siedlcach Sp. z o.o. /ID# 271692
Siedlce, Masovian Voivodeship 08-110
Poland
Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku /ID# 272169
Bialystok, Podlaskie Voivodeship 15-027
Poland
National Cancer Center /ID# 272265
Goyang-si, Gyeonggido 10408
South Korea
CHA Bundang Medical Center /ID# 271590
Seongnam, Gyeonggido 13496
South Korea
Seoul National University Bundang Hospital /ID# 271594
Seongnam-si, Gyeonggido 13620
South Korea
Keimyung University Dongsan Hospital /ID# 271592
Daegu, Gyeongsangbuk-do 42601
South Korea
Seoul National University Hospital /ID# 272264
Seoul, Seoul Teugbyeolsi 03080
South Korea
Yonsei University Health System Severance Hospital /ID# 271593
Seoul, Seoul Teugbyeolsi 03722
South Korea
Asan Medical Center /ID# 272130
Seoul, Seoul Teugbyeolsi 05505
South Korea
Gangnam Severance Hospital /ID# 272217
Seoul, Seoul Teugbyeolsi 06273
South Korea
Samsung Medical Center /ID# 271591
Seoul, Seoul Teugbyeolsi 06351
South Korea
Hospital Universitario Germans Trias i Pujol /ID# 272216
Badalona, Barcelona 08916
Spain
Hospital Universitario de Jaén /ID# 272205
Jaén, Jaen 23007
Spain
Hospital Clínico Universitario Virgen de la Arrixaca /ID# 272223
El Palmar, Murcia 30120
Spain
Clinica Universidad de Navarra - Pamplona /ID# 275742
Pamplona, Navarre 31008
Spain
Hospital Universitario Virgen del Rocio /ID# 272107
Seville, Sevilla 41013
Spain
Hospital Universitario Vall de Hebron /ID# 272134
Barcelona, 08035
Spain
Hospital General Universitario Gregorio Maranon /ID# 272121
Madrid, 28007
Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 272221
Madrid, 28027
Spain
Hospital Universitario HM Sanchinarro /ID# 272190
Madrid, 28050
Spain
Hospital Clinico Universitario de Valencia /ID# 272218
Valencia, 46010
Spain
Hospital Clinico Universitario Lozano Blesa /ID# 272165
Zaragoza, 50009
Spain
Addenbrookes Hospital /ID# 272162
Cambridge, Cambridgeshire CB2 2QQ
United Kingdom
Royal Devon and Exeter Hospital /ID# 272170
Exeter, Devon EX2 5DW
United Kingdom
University College London Hospital /ID# 272115
London, Greater London NW1 2BU
United Kingdom