Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
NCT ID: NCT05549297
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
540 participants
INTERVENTIONAL
2022-12-19
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Tebentafusp Monotherapy
Participants receive tebentafusp as single agent.
Tebentafusp
Soluble gp100-specific T cell receptor with anti-CD3 scFV
Arm B: Tebentafusp + Pembrolizumab
Participants receive tebentafusp in combination with pembrolizumab.
Tebentafusp with Pembrolizumab
Soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with pembrolizumab
Arm C: Investigator's Choice
Participants receive investigator's choice of therapy.
Investigators Choice
Investigators choice of therapy
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* diagnosis of ocular or metastatic uveal melanoma
* history of a malignant disease other than those being treated in this study
* ineligible to be retreated with pembrolizumab due to a treatment-related AE
* known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
* previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
* active autoimmune disease requiring immunosuppressive treatment
* clinically significant cardiac or pulmonary disease or impaired cardiac function
* known psychiatric or substance abuse disorders
* received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication or who have not completed adequate washout from prior medications.
* received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose
* received cellular therapies within 90 days of study intervention
* ongoing Common Terminology Criteria for Adverse Events(CTCAE) Grade ≥ 2 clinically significant who in the opinion of the investigator could affect the outcome of the study
* received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose
* have not progressed on treatment with an anti-PD(L)1 mAb
* have not received prior treatment with an approved anti-CTLA-4 mAb
* a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen
* currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose
* known history of chronic viral infections such as hepatitis B virus (HBV) or hepatitis C virus (HCV)
* known clinically significant pulmonary or cardiac disease or impaired lung or cardiac function
* Out of range Laboratory values
* history of allogenic tissue/solid organ transplant
18 Years
ALL
No
Sponsors
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Immunocore Ltd
INDUSTRY
Responsible Party
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Locations
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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
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 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
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
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
Vienna, , Austria
Cliniques Universitaires Sain-Luc
Brussels, , Belgium
UZ Brussel
Jette, , Belgium
UZ Leuven
Leuven, , Belgium
Princess Margaret Hospital
Toronto, Ontario, 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
Napoli, , 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
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
Countries
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Central Contacts
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Other Identifiers
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IMCgp100-203
Identifier Type: -
Identifier Source: org_study_id
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