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Brief Title: Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer (GLORIOSA)
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 (GLORIOSA)
Study ID: NCT05445778
Brief Summary: GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.
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. .
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
USA Mitchell Cancer Institute, Mobile, Alabama, United States
Honor Health Cancer Care, Biltmore, 2222 E. Highland Ave, #400, Phoenix, Arizona, United States
John Muir Health, Concord, California, United States
City of Hope, Irvine, California, United States
Kaiser Permanente Irvine Medical Center, 6650 Alton Pkwy, Irvine, California, United States
UC San Diego Health - Moores Cancer Center, La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center, 4950 Sunset Blvd., 6th Floor, Los Angeles, California, United States
UCI Health- Chao Family Comprehensive Cancer Center, Orange, California, United States
Stanford University, Palo Alto, California, United States
Kaiser Permanente Riverside Medical Center, 10800 Magnolia Ave, Riverside, California, United States
Kaiser Permanente Zion Medical Center, 4647 Zion Ave, San Diego, California, United States
Kaiser Permanente San Marcos Medical Offices, 400 Craven Road, San Marcos, California, United States
Olive View UCLA Medical Center Inpatient Pharmacy, 14445 Olive View Dr, Rm 1C101, Sylmar, California, United States
Broward Health Medical Center, Fort Lauderdale, Florida, United States
Regional Cancer Center/ Florida Gynecologic Oncology, Fort Myers, Florida, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer Center, Miami, Florida, United States
Sarasota Memorial Health Care System, Sarasota, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Rush University Medical Center, 1725 West Harrison Street, Chicago, Illinois, United States
University of Chicago Medicine, 5841 S Maryland Ave, MC 2115, Chicago, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
St Vincent Gynecologic Oncology, Indianapolis, Indiana, United States
University of Iowa Health Care, Iowa City, Iowa, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Baptist Health Lexington, Lexington, Kentucky, United States
University of Kentucky, Lexington, Kentucky, United States
LSUHSC, New Orleans, Louisiana, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Maine Medical Center, Scarborough, Maine, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Sinai Hospital of Baltimore, Inc., Baltimore, Maryland, United States
Johns Hopkins Medical Institute, Baltimore, Maryland, United States
Baystate Gynecologic Oncology - Tolosky Center, Springfield, Massachusetts, United States
Corewell Health, Grand Rapids, Michigan, United States
Minnesota Oncology Hematology, P.A. (USOR), Maplewood, Minnesota, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Center of Hope at Renown Medical Center, Reno, Nevada, United States
Dartmouth Hitchcock Medical, One Medical Center Drive, Lebanon, New Hampshire, United States
John Theurer Cancer Center, University Medical Center, 92 Second Street, Hackensack, New Jersey, United States
The Valley Hospital -Luckow Pavilion, Paramus, New Jersey, United States
Holy Name Medical Center, Teaneck, New Jersey, United States
New York Oncology Hematology, P.C. (USOR), Albany, New York, United States
Perlmutter Cancer Center at NYU Langone Health-Long Island, Mineola, New York, United States
Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
Mount Sinai Hospital, New York, New York, United States
Northwell Health Cancer Institute, New York, New York, United States
Womens Cancer Care Associates, New York, New York, United States
UNC-Chapel Hill, Chapel Hill, North Carolina, United States
Duke Cancer Center, Durham, North Carolina, United States
University of Cincinnati, Cincinnati, Ohio, United States
Ohio State University, Columbus, Ohio, United States
Kettering Health, Kettering, Ohio, United States
OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute, Tulsa, Oklahoma, United States
Willamette Valley Cancer Institute and Research Center (USOR), Eugene, Oregon, United States
Northwest Cancer Specialists, P.C. (USOR), Portland, Oregon, United States
OHSU Center for Health & Healing, Building 2 (CHH2), 3485 S Bond Ave, Portland, Oregon, United States
Allegheny Health Network, Pittsburgh, Pennsylvania, United States
Sidney Kimmel Cancer Center Asplundh Cancer Pavilion, Willow Grove, Pennsylvania, United States
Sanford Gynecologic Oncology, 1309 W. 17th street, Sioux Falls, South Dakota, United States
The West Clinic, PLLC dba West Cancer Center, Germantown, Tennessee, United States
Texas Oncology, P.A. (USOR), Austin, Texas, United States
Texas Oncology - DFWW (USOR), Bedford, Texas, United States
Texas Oncology-Dallas Presbyterian Hospital (USOR), Dallas, Texas, United States
Texas Oncology (USOR), Fort Worth, Texas, United States
Texas Oncology - San Antonio (USOR), San Antonio, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Virginia Oncology Associates (USOR), Norfolk, Virginia, United States
Virginia Commonwealth University (VCU)- Massey Comprehensive Cancer Center, Richmond, Virginia, United States
Westmead Hospital, Westmead, New South Wales, Australia
Gold Coast University Hospital, Southport, Queensland, Australia
Grampians Health Service, Ballarat, Victoria, Australia
Cabrini Health, Brighton, Victoria, Australia
Monash Health, Clayton, Victoria, Australia
Peter Maccallum Cancer Centre, Melbourne, Victoria, Australia
Epworth Health, Richmond, Victoria, Australia
Bendat Family Comprehensive Cancer Centre St John of God - Subiaco Hospital, Subiaco, , Australia
Imeldaziekenhuis, Apotheek Klinische Studies, Imeldalaan 9 Centraal Magazjin, Bonheiden, , Belgium
Cliniques Universitaires St-Luc Woluwe-Saint-Lambert, Brussel, , Belgium
GHDC Grand Hôpital de Charleroi, Site Notre-Dame, Grand Rue 3, Charleroi, , Belgium
AZ Sint Lucas Gent, Groenebriel 1, Gent, , Belgium
UZ Leuven, Apotheek Klinische studies, Herestraat, 49, Leuven, , Belgium
CHU UCL Namur - Site Sainte-Elisabeth, Route (Road) 471 Place Louise Godin 15, Oncology Day Hospital, 3rd Floor, Namur, , Belgium
AZ Delta apotheek, Tav Klinische studies, Kwadestraat 78, Roeselare, , Belgium
Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada
University of Alberta - Cross Cancer Institute (CCI), Edmonton, Alberta, Canada
BC Cancer - Vancouver, Vancouver, British Columbia, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Kinston Health Sciences Center - KGH Site, Kingston, Ontario, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR), Montreal, Quebec, Canada
Centre Hospitalier de L'Universite de Montreal - Centre de Recherche, Montreal, Quebec, Canada
McGill University Health Centre, Montreal, Quebec, Canada
CHUS - Hôpital Fleurimont, Sherbrooke, Quebec, Canada
University Hospital Brno, Brno, , Czechia
Nemocnice AGEL Nový Jicín a.s., Nový Jicín, , Czechia
University Hospital Ostrava, Ostrava Poruba, , Czechia
General University Hospital in Prague, Prague, , Czechia
Carmel Medical Centre, Haifa, , Israel
Wolfson Medical Centre, Holon, , Israel
Hadassah Medical Ctr. Ein Kerem. Sharett Institute of oncology, Jerusalem, , Israel
Shaare Zedek Medical Centre, Jerusalem, , Israel
Meir Medical Centre, Kefar Sava, , Israel
Rabin Medical Centre, Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv Yaffo, , Israel
Policlinico S. Orsola-Malpighi, Bologna, , Italy
AOU Careggi, Firenze, , Italy
ASST Ospedale Alessandro Manzoni, Lecco, , Italy
Azienda USL Toscana Nord Ovest Ospedale San Luca, Lucca, , Italy
IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
IRCCS San Raffaele, Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Ospedale di Mirano, Mirano, , Italy
AOU di Parma, Parma, , Italy
AUSL Piacenza Ospedale Guglielmo da Saliceto, Piacenza, , Italy
Nuovo Ospedale di Prato - Santo Stefano, Prato, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, , Italy
National Cancer Center, Goyang, Gyeonggi-do, Korea, Republic of
CHA University - Bundang CHA General Hospital, Seongnam, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea, Republic of
Keimyung Dongsan University Hospital, Daegu, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
The Medical City -Ortigas, Pasig, Metro Manila, Philippines
Cardinal Santos Medical Center, San Juan, Metro Manila, Philippines
East Avenue Medical Centre, Quezon City, , Philippines
Hospital Universitario Vall d'Hebron, CT Pharm General Building-Floor B, Passeig Vall d'Hebron, Barcelona, , Spain
Instituto Catalán de Oncologia, 199-203 Av Gra Via CT Pharmacy, Hospital Duran i Reynals, Barcelona, , Spain
Hospital Clinic de Barcelona (Hospital Clinic i Provincial), Barcelona, , Spain
Hospital Universitario de A Coruña (CHUAC), Coruña, , Spain
ICO-Hospital Universitario de Girona, Girona, , Spain
Clínica Universidad de Navarra, Madrid, , Spain
Hospital La Paz CT Pharmacy, 261 Paseo Castellana, North Building Ground Floor, Madrid, , Spain
Clinica Universitaria Navarra Pamplona, Pamplona, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
The Royal Marsden NHS Foundation Trust, Fulham, London, United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
Cheltenham General Hospital, Cheltenham, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust, London, , United Kingdom
Mount Vernon Cancer Centre East and North Hertfordshire NHS Trust, Northwood, , United Kingdom
Southampton University NHS Trust, Southampton, , United Kingdom
Singleton Hospital, Swansea, , United Kingdom