Spots Global Cancer Trial Database for Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
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Trial Identification
Brief Title: Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
Official Title: A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma
Study ID: NCT03070392
Conditions
Study Description
Brief Summary: To evaluate the overall survival of HLA-A\*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.
Detailed Description: This Phase II study is designed to evaluate the safety and efficacy of IMCgp100 compared with Investigator's Choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A\*0201 positive adult patients with advanced UM treated in the first line setting with no prior systemic or liver-directed chemo-, radio- or immune-therapy administered in the advanced setting (prior surgical resection of liver metastases and adjuvant systemic therapy are acceptable). Comparison of the IMCgp100 efficacy results in this Phase II study will be made with the concurrently randomized arm (Investigator's Choice) with a primary endpoint of overall survival (OS) and secondary efficacy endpoints of progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and disease control rate (DCR).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA Medical Center, Los Angeles, California, United States
The Angeles Clinic and Research Institute, Los Angeles, California, United States
Byers Eye Institute, Stanford University, Palo Alto, California, United States
California Pacific Medical Center, San Francisco, California, United States
University of Colorado, Aurora, Colorado, United States
University of Miami - Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
The University of Chicago Medicine, Chicago, Illinois, United States
University of Iowa, Iowa City, Iowa, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Health System, Durham, North Carolina, United States
The Ohio State University, Columbus, Ohio, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
Portland Providence Medial Center, Portland, Oregon, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Houston Methodist Cancer Center, Houston, Texas, United States
Saint Vincents Hospital, Darlinghurst, New South Wales, Australia
Central Adelaide Local Health Network, Royal Adelaide Hospital Cancer Center, Adelaide, South Australia, Australia
Peter MacCallum Cancer Center, Melbourne, Victoria, Australia
Institut Roi Albert II Cliniques Universitaires St-Luc, Bruxelles, , Belgium
Cross Cancer Institute, Edmonton, Alberta, Canada
Princess Margaret Cancer Centre, Toronto, , Canada
Centre Atoine Lacassagne, Nice, , France
Institut Curie, Paris, , France
Universitaetsklinikum Koeln Dermatologie und Venerologie, Koeln, Nordrhein Westfalen, Germany
Charite - Campus Benjamin Franklin, Berlin, , Germany
Universitätsklinikum Carl Gustav Carus, Dresden, , Germany
University Hospital Essen, Essen, , Germany
University of Hamburg, Hamburg, , Germany
Nationales Centrum für Tumorerkrankungen, Heidelberg, , Germany
Klinik und Poliklinik für Dermatologie und Allergologie, Munich, , Germany
Fondazione ICCRS, Milan, , Italy
Istituto Nazionale Tumori - IRCCS Fondazione "G. Pascale" - UOC Melanoma, Immunoterapia Oncologica e Terapie Innovative, Napoli, , Italy
LUMC Medical Oncology, Leiden, , Netherlands
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Warsaw, , Poland
Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology, Moscow, , Russian Federation
Federal State Budget Institution National Medical Research Center of Oncology, Saint Petersburg, , Russian Federation
Institut Catala d'Oncologia (ICO) - L'Hospitalet, L'Hospitalet De Llobregat, ES-Spain, Spain
Hospital Universitario La Paz, Madrid, ES-Spain, Spain
Hospital Clínico Universitario de Santiago de Compostela, Santiago De Compostela, ES-Spain, Spain
Hospital Universitario General de Valencia, Valencia, ES-Spain, Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
University of Zurich Hospital, Zürich, , Switzerland
Dnipropetrovsk State Medical Academy, Dnipropetrovs'k, , Ukraine
Kyiv Munitipal Hospital, Kyiv, , Ukraine
Uzhhorod Central City Clinical Hospital, Uzhhorod, , Ukraine
Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom
The Clatterbridge Cancer Centre, Bebington, Wirral, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Contact Details
Name: Immunocore Medical Information
Affiliation: Immunocore Ltd
Role: STUDY_DIRECTOR
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