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)
Status: Recruiting
Location: See all (72) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• HLA-A\*02:01-positive
• unresectable Stage III or Stage IV non-ocular melanoma
• archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
• measurable or non-measurable disease per RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• If applicable, must agree to use highly effective contraception
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol
• Must agree to provide protocol specified samples for biomarker analyses.
Locations
United States
Arizona
Mayo Clinic Arizona
RECRUITING
Phoenix
Florida
Mayo Clinic Florida
RECRUITING
Jacksonville
Orlando Health Cancer Institute
RECRUITING
Orlando
Georgia
Winship Cancer Institute of Emory University
RECRUITING
Atlanta
Kansas
University of Kansas Cancer Center - Westwood
RECRUITING
Westwood
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Minnesota
Mayo Clinic Minnesota
RECRUITING
Rochester
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
New York
Northwell Health Cancer Institute - Zuckerberg Cancer Center
RECRUITING
Lake Success
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Oklahoma
OU Health Stephenson Cancer Center
RECRUITING
Oklahoma City
Pennsylvania
Thomas Jefferson University Medical Oncology Clinic
RECRUITING
Philadelphia
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Tennessee
University of Tennessee Medical Center
RECRUITING
Knoxville
Texas
Houston Methodist Hospital/Houston Methodist Cancer Center
RECRUITING
Houston
Utah
University of Utah Huntsman Cancer Institute
RECRUITING
Salt Lake City
Other Locations
Australia
Gallipoli Medical Research Foundation (GMRF)
RECRUITING
Greenslopes
Alfred Health
RECRUITING
Melbourne
Melanoma Institute Australia
RECRUITING
Wollstonecraft
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
LKH - Universitaetsklinikum Graz
RECRUITING
Graz
Kepler Universitätsklinikum
RECRUITING
Linz
Universitatsklinik fur Innere Medizin 3
RECRUITING
Salzburg
AKH - Medizinische Universität Wien
RECRUITING
Vienna
Belgium
Cliniques Universitaires Sain-Luc
RECRUITING
Brussels
UZ Brussel
RECRUITING
Jette
UZ Leuven
RECRUITING
Leuven
Canada
Princess Margaret Hospital
RECRUITING
Toronto
France
CHU de Bordeaux - Hopital Saint Andre
RECRUITING
Bordeaux
Centre Leon Berard
RECRUITING
Lyon
Hopital de la Timone [Recruiting]
RECRUITING
Marseille
Hopital Saint Lous - APHP
RECRUITING
Paris
Institute Claudius Regaud
RECRUITING
Toulouse
Institut Gustave Roussy
RECRUITING
Villejuif
Germany
Charité - Campus Charité Mitte
RECRUITING
Berlin
Universitatsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Universitaetsklinikum Erlangen
RECRUITING
Erlangen
Universitaetsklinikum Essen
RECRUITING
Essen
Universitaetsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
Universitaetsklinikum Heidelberg
RECRUITING
Heidelberg
Universitaetsklinikum Schleswig-Holstein
RECRUITING
Kiel
Johannes Wesling Klinikum Minden
RECRUITING
Minden
LMU-Campus Innenstadt
RECRUITING
München
Universitaetsklinikum Schleswig-Holstein
RECRUITING
Schleswig
Universitaetsklinikum Tübingen
RECRUITING
Tübingen
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Instituto Nazionale Tumori Fondazione G. Pascale
RECRUITING
Napoli
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
RECRUITING
Perugia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
A.O.U Senese Policlinico Santa Maria alle Scotte
RECRUITING
Siena
Poland
Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy
RECRUITING
Bydgoszcz
Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii
RECRUITING
Gdansk
Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu
RECRUITING
Poznan
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
RECRUITING
Warsaw
Spain
Hospital Clinico de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Regional Universitario de Malaga
RECRUITING
Málaga
Hospital General Universitario de Valencia
RECRUITING
Valencia
Switzerland
Kantonsspital St. Gallen
RECRUITING
Sankt Gallen
Universitaetsspital Zurich
RECRUITING
Zurich
United Kingdom
Queen Elizabeth Hospital
RECRUITING
Birmingham
Addenbrooke's Hospital
RECRUITING
Cambridge
Leeds General Infirmary
RECRUITING
Leeds
Guys & St Thomas' NHS Foundation Trust
RECRUITING
London
Royal Marsden Hospital - Chelsea
RECRUITING
London
Sarah Cannon Research Institute UK
RECRUITING
London
Mount Vernon Cancer Center
RECRUITING
Middlesex
Royal Marsden Hospital - Sutton
RECRUITING
Sutton
Contact Information
Primary
Immunocore Medical Information
medical.information@immunocore.com
844-466-8661
Backup
Immunocore Medical Information EU
medinfo.eu@immunocore.com
+00 800-744-51111
Time Frame
Start Date: 2022-12-19
Estimated Completion Date: 2028-07
Participants
Target number of participants: 540
Treatments
Experimental: Arm A: Tebentafusp Monotherapy
Participants receive tebentafusp as single agent.
Experimental: Arm B: Tebentafusp + Pembrolizumab
Participants receive tebentafusp in combination with pembrolizumab.
Experimental: Arm C: Investigator's Choice
Participants receive investigator's choice of therapy.
Related Therapeutic Areas
Sponsors
Leads: Immunocore Ltd