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Spots Global Cancer Trial Database for Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer (GLORIOSA)

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Trial Identification

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

Study Description

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. .

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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