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Spots Global Cancer Trial Database for Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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