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Brief Title: Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
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)
Study ID: NCT05549297
Brief Summary: To evaluate the efficacy and safety of tebentafusp-based regimens 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
Detailed Description: This is a Phase 2/3, multicenter, open-label study to evaluate the efficacy and safety of tebentafusp as monotherapy (Arm A) and in combination with pembrolizumab (Arm B) compared with standard of care or best supportive care (Arm C) in participants with non-ocular advanced melanoma who have progressed on a prior anti-PD(L)1 regimen, received prior ipilimumab and, if the participant has a BRAF mutation, a prior BRAF tyrosine kinase inhibitor (TKI) regimen.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Minnesota Medical Center - Masonic Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic Minnesota, Rochester, Minnesota, 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
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
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, Wien, , Austria
Cliniques Universitaires Sain-Luc, Bruxelles, , Belgium
UZ Brussel, Jette, , Belgium
UZ Leuven, Leuven, , Belgium
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
Klinische Studien Hauttumorcentrum, Berlin, , Germany
Universitatsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Onkologische Studienxentrale Houtklinik 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, Munich, , Germany
Universitaetsklinikum Tübingen, Tübingen, , Germany
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Instituto Nazionale Tumori Fondazione G. Pascale, Napoli, , Italy
Italy, Perugia 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, Gdańsk, , Poland
Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu, Poznań, , 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, Saint Gallen, , Switzerland
Universitaetsspital Zurich, Zürich, , Switzerland
Addenbrooke's Hospital, Cambridge, Cambridgeshire, United Kingdom
Guy's & St Thomas' NHS Foundation Trust, Lambeth, Greater London, United Kingdom
Queen Elizabeth Hospital, Birmingham, West Midlands, United Kingdom
Leeds General Infirmary, Leeds, , United Kingdom
Barts Hospital, London, , United Kingdom
Royal Marsden Hospital - Chelsea, London, , United Kingdom
Mount Vernon Cancer Center, Middlesex, , United Kingdom
Royal Marsden Hospital - Sutton, Sutton, , United Kingdom