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Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Sponsor: Immunocore Ltd
Summary
The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care \[SoC\], best supportive care \[BSC\] on protocol survivor follow up) in patients with advanced non-ocular melanoma.
Official title: Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
540
Start Date
2022-12-19
Completion Date
2028-07
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
Tebentafusp
Soluble gp100-specific T cell receptor with anti-CD3 scFV
Tebentafusp with Pembrolizumab
Soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with pembrolizumab
Investigators Choice
Investigators choice of therapy
Locations (82)
Mayo Clinic Arizona
Phoenix, Arizona, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
St Elizabeth Healthcare (St Elizabeth Medical Center)
Edgewood, Kentucky, United States
St Elizabeth Healthcare (St Elizabeth Medical
Edgewood, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic Minnesota
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Northwell Health Cancer Institute - Zuckerberg Cancer Center
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Thomas Jefferson University Medical Oncology Clinic
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Gibbs Cancer Center and Research Institute
Spartanburg, South Carolina, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Houston Methodist Hospital/Houston Methodist Cancer Center
Houston, Texas, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia
Gallipoli Medical Research Foundation (GMRF)
Greenslopes, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Alfred Health
Melbourne, Victoria, Australia
LKH - Universitaetsklinikum Graz
Graz, Austria
Kepler Universitätsklinikum
Linz, Austria
Universitatsklinik fur Innere Medizin 3
Salzburg, Austria
AKH - Medizinische Universität Wien
Vienna, Austria
Cliniques Universitaires Sain-Luc
Brussels, Belgium
UZ Brussel
Jette, Belgium
UZ Leuven
Leuven, Belgium
BC Cancer
Vancouver, British Columbia, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Lady Davis Institute for Medical Research (LDI) Jewish General Hospital (JGH)
Montreal, Quebec, Canada
Centre Leon Berard
Lyon, Cedex, France
Institute Claudius Regaud
Toulouse, Cedex, France
Institut Gustave Roussy
Villejuif, Cedex, France
CHU de Bordeaux - Hopital Saint Andre
Bordeaux, France
Hopital de la Timone [Recruiting]
Marseille, France
Hopital Saint Lous - APHP
Paris, France
Universitaetsklinikum Schleswig-Holstein
Schleswig, Kiel, Germany
Charité - Campus Charité Mitte
Berlin, Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Universitaetsklinikum Erlangen
Erlangen, Germany
Universitaetsklinikum Essen
Essen, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitaetsklinikum Heidelberg
Heidelberg, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, Germany
Johannes Wesling Klinikum Minden
Minden, Germany
LMU-Campus Innenstadt
München, Germany
Universitaetsklinikum Tübingen
Tübingen, Germany
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Instituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
A.O.U Senese Policlinico Santa Maria alle Scotte
Siena, Italy
Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz, Poland
Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii
Gdansk, Poland
Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu
Poznan, Poland
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, Poland
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clinico de Barcelona
Barcelona, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Regional Universitario de Malaga
Málaga, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Universitaetsspital Zurich
Zurich, Switzerland
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
The Christie NHS Foundation Trust
Manchester, England, United Kingdom
Queen Elizabeth Hospital
Birmingham, West Midlands, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
Guys & St Thomas' NHS Foundation Trust
London, United Kingdom
Sarah Cannon Research Institute UK
London, United Kingdom
Royal Marsden Hospital - Chelsea
London, United Kingdom
Mount Vernon Cancer Center
Middlesex, United Kingdom
Royal Marsden Hospital - Sutton
Sutton, United Kingdom