Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Start Date
12/19/2022
Completion Date
7/1/2028
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.
Detailed Description
This is a phase 3 (as upon conversion to phase 3 there were no changes to the arms listed herein), 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 an approved anti-CTLA4 regimen and, if the participant has a BRAF mutation, a prior BRAF tyrosine kinase inhibitor (TKI) regimen.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Tebentafusp
Tebentafusp with Pembrolizumab
Investigators Choice
Conditions
Locations
Mayo Clinic Arizona
Phoenix, Arizona 85054
United States
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
Orlando Health Cancer Institute
Orlando, Florida 32806
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United States
University of Kansas Cancer Center - Westwood
Westwood, Kansas 66205
United States
St Elizabeth Healthcare (St Elizabeth Medical Center)
Edgewood, Kentucky 41017
United States
St Elizabeth Healthcare (St Elizabeth Medical
Edgewood, Kentucky 41017
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts 02215
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United States
Mayo Clinic Minnesota
Rochester, Minnesota 55905
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United States
Northwell Health Cancer Institute - Zuckerberg Cancer Center
Lake Success, New York 11042
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10068
United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Thomas Jefferson University Medical Oncology Clinic
Philadelphia, Pennsylvania 19107
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Gibbs Cancer Center and Research Institute
Spartanburg, South Carolina 29303
United States
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United States
Houston Methodist Hospital/Houston Methodist Cancer Center
Houston, Texas 77030
United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
Melanoma Institute Australia
Wollstonecraft, New South Wales 2065
Australia
Gallipoli Medical Research Foundation (GMRF)
Greenslopes, Queensland 4120
Australia
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
Australia
Alfred Health
Melbourne, Victoria 3004
Australia
LKH - Universitaetsklinikum Graz
Graz, 8036
Austria
Kepler Universitätsklinikum
Linz, 4020
Austria
Universitatsklinik fur Innere Medizin 3
Salzburg, 5020
Austria
AKH - Medizinische Universität Wien
Vienna, 1090
Austria
Cliniques Universitaires Sain-Luc
Brussels, 1200
Belgium
UZ Brussel
Jette, 1090
Belgium
UZ Leuven
Leuven, 3000
Belgium
BC Cancer
Vancouver, British Columbia V5Z 4E6
Canada
Princess Margaret Hospital
Toronto, Ontario M5G 2M9
Canada
Lady Davis Institute for Medical Research (LDI) Jewish General Hospital (JGH)
Montreal, Quebec H3T 1E2
Canada
Centre Leon Berard
Lyon, Cedex 69373
France
Institute Claudius Regaud
Toulouse, Cedex 31059
France
Institut Gustave Roussy
Villejuif, Cedex 94805
France
CHU de Bordeaux - Hopital Saint Andre
Bordeaux, 22075
France
Hopital de la Timone [Recruiting]
Marseille, 13005
France
Hopital Saint Lous - APHP
Paris, 75010
France
Universitaetsklinikum Schleswig-Holstein
Schleswig, Kiel 24105
Germany
Charité - Campus Charité Mitte
Berlin, 10115
Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Germany
Universitaetsklinikum Erlangen
Erlangen, 91054
Germany
Universitaetsklinikum Essen
Essen, 45147
Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120
Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105
Germany
Johannes Wesling Klinikum Minden
Minden, 32429
Germany
LMU-Campus Innenstadt
München, 80337
Germany
Universitaetsklinikum Tübingen
Tübingen, 72076
Germany
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Italy
Instituto Nazionale Tumori Fondazione G. Pascale
Naples, 80131
Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, 6156
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Italy
A.O.U Senese Policlinico Santa Maria alle Scotte
Siena, 53100
Italy
Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz, 85-796
Poland
Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii
Gdansk, 80214
Poland
Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu
Poznan, 60355
Poland
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, 02781
Poland
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital Clinico de Barcelona
Barcelona, 08036
Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034
Spain
Hospital Regional Universitario de Malaga
Málaga, 29010
Spain
Hospital General Universitario de Valencia
Valencia, 46014
Spain
Kantonsspital St. Gallen
Sankt Gallen, 9000
Switzerland
Universitaetsspital Zurich
Zurich, 8058
Switzerland
Addenbrooke's Hospital
Cambridge, Cambridgeshire CB2 0QQ
United Kingdom
The Christie NHS Foundation Trust
Manchester, England M20 4BX
United Kingdom
Queen Elizabeth Hospital
Birmingham, West Midlands B15 2TH
United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX
United Kingdom
Guys & St Thomas' NHS Foundation Trust
London, SE1 9RT
United Kingdom
Sarah Cannon Research Institute UK
London, SE1 9RT
United Kingdom
Royal Marsden Hospital - Chelsea
London, SW3 6JJ
United Kingdom
Mount Vernon Cancer Center
Middlesex, HA6 2RN
United Kingdom
Royal Marsden Hospital - Sutton
Sutton, SM2 5PT
United Kingdom