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Brief Title: IMGN853 With Carboplatin in Second-line Treatment of FRα Expressing, Platinum-sensitive Epithelial Ovarian Cancer
Official Title: Multicenter, Open-label, ph 2 Study of Carboplatin Plus Mirvetuximab Soravtansine Followed by Mirvetuximab Soravtansine Continuation in FRα Positive, Recurrent Platinum-sensitive, High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Following 1 Prior Line of Platinum-based Chemotherapy
Study ID: NCT05456685
Brief Summary: IMGN853-0420 is a multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following 1 prior line of platinum-based chemotherapy.
Detailed Description: This Phase 2 study is designed to evaluate the efficacy and safety of MIRV in combination with carboplatin followed by MIRV continuation in FRα-positive patients with recurrent platinum-sensitive ovarian cancer (PSOC) following 1 prior line of platinum-based chemotherapy. Upon completion of carboplatin plus MIRV combination chemotherapy (6 cycles), patients without progressive disease will continue on single-agent MIRV. Patients must have confirmation of FRα positivity by the Ventana FOLR1 Assay.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Arizona Cancer Center, Tucson, Arizona, United States
Providence Medical Foundation, Fullerton, California, United States
Scripps MD Anderson Cancer Center, La Jolla, California, United States
University of California San Diego (UCSD) - Moores Cancer Center, La Jolla, California, United States
University of Southern California, Los Angeles, California, United States
University of California, Los Angeles, California, United States
Hoag Hospital, Newport Beach, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
California Pacific Medical Center, San Francisco, California, United States
Smilow Cancer Hospital, New Haven, Connecticut, United States
AdventHealth Orlando - Cancer Institute, Orlando, Florida, United States
Sarasota Memorial Health Care System, Sarasota, Florida, United States
H Lee Moffitt Cancer Center, Tampa, Florida, United States
Emory University, Atlanta, Georgia, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
Northwestern University - Kishwaukee Cancer Center, DeKalb, Illinois, United States
Northwestern University - Delnor Cancer Center, Geneva, Illinois, United States
Northwestern University - Warrenville Cancer Center, Warrenville, Illinois, United States
Women's Cancer Care, Covington, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Center of Hope, Reno, Nevada, United States
MD Anderson Cancer Center at Cooper, Camden, New Jersey, United States
Holy Name Medical Center, Teaneck, New Jersey, United States
New Mexico Cancer Care Alliance / University of New Mexico CCC, Albuquerque, New Mexico, United States
Presbyterian Rust Medical Center/Jorgensen Cancer Center, Rio Rancho, New Mexico, United States
Columbia University Medical Center, New York, New York, United States
Northwell Health, Whitestone, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Duke Cancer Center, Durham, North Carolina, United States
OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Women & Infants Hospital of Rhode Island, Providence, Rhode Island, United States
Medical University of South Carolina - Hollings Cancer Center, Charleston, South Carolina, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Kadlec Clinic Hematology/Oncology, Kennewick, Washington, United States
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
UZLeuven, Leuven, , Belgium
CHU de Liege, Liège, , Belgium
BC Cancer Vancouver, Vancouver, British Columbia, Canada
CIUSSS de l'IIe-de-Montreal, Montréal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada
McGill University Health Centre, Montréal, Quebec, Canada
Ciussse-Chus, Sherbrooke, Quebec, Canada
LTD "High Technology Hospital Medcenter", Batumi, , Georgia
LLC American Hospital Network, Tbilisi, , Georgia
Israel Georgian Medical Research Clinic Healthycore, Tbilisi, , Georgia
JSC Vian - Caraps Medline, Tbilisi, , Georgia
Ltd - Consilium Medulla, Tbilisi, , Georgia
Hospital Teresa Herrera-Chuac, A Coruña, , Spain
Hospital Universitario De Badajoz, Badajoz, , Spain
Hospital Dexeus, Barcelona, , Spain
Vall d'Hebron Institute of Oncology, Barcelona, , Spain
Catalan Institute of Oncology ICO, Barcelona, , Spain
Hospital Universitario Reina Sofia, Córdoba, , Spain
H. U Arnau de Vilanova de Lleida, Lleida, , Spain
Clinica Universidad de Navarra, Madrid, , Spain
START Madrid Fundación Jiménez Díaz, Madrid, , Spain
12 de Octubre University Hospital, Madrid, , Spain
Hm Sanchinarro Ciocc, Madrid, , Spain
Clinica Universidad de Navarra - Pamplona, Pamplona, , Spain
Hospital Clinico de Valencia, Valencia, , Spain
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
Guy's Hospital, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
The Christie NUS Foundation Trust, Manchester, , United Kingdom
Mount Vernon Cancer Centre, Northwood, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Musgrove Park Hospital, Taunton, , United Kingdom
Name: Gottfried Konecny, MD
Affiliation: University of California, Los Angeles
Role: PRINCIPAL_INVESTIGATOR
Name: Ana Oaknin, MD
Affiliation: Vall d'Hebron Institute of Oncology
Role: PRINCIPAL_INVESTIGATOR
Name: Susana Banerjee, MD
Affiliation: Royal Marsden NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR