Actively Recruiting
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Led by Immunocore Ltd · Updated on 2026-02-25
540
Participants Needed
82
Research Sites
288 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HLA-A*02:01-positive
- Unresectable Stage III or Stage IV non-ocular melanoma
- Archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated provided
- Measurable or non-measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- If applicable, agree to use highly effective contraception
- Capable of giving signed informed consent including compliance with requirements and restrictions
- Agree to provide protocol specified samples for biomarker analyses
You will not qualify if you...
- Pregnant or lactating women
- Diagnosis of ocular or metastatic uveal melanoma
- History of malignant disease other than those treated in this study
- Ineligible to be retreated with pembrolizumab due to treatment-related adverse events
- Known untreated or symptomatic central nervous system metastases and/or carcinomatous meningitis
- Previous severe hypersensitivity reaction to treatment with another monoclonal antibody
- Active autoimmune disease requiring immunosuppressive treatment
- Known psychiatric or substance abuse disorders
- Prior treatment with licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer medication or incomplete washout
- Chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose
- Cellular therapies within 90 days of study intervention
- Ongoing CTCAE Grade ≥ 2 clinically significant conditions affecting study outcome
- Systemic treatment with steroids or immunosuppressive drugs within 2 weeks of first dose
- No progression on anti-PD(L)1 mAb treatment
- No prior treatment with approved anti-CTLA-4 mAb
- BRAF V600 mutation without prior BRAF/MEK TKI regimen
- Participation in investigational agent/device study within 30 days of first dose
- Known history of chronic viral infections such as hepatitis B or C
- Clinically significant pulmonary or cardiac disease or impaired lung or cardiac function
- Out of range laboratory values
- History of allogenic tissue or solid organ transplant
AI-Screening
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Trial Site Locations
Total: 82 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
Actively Recruiting
4
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States, 66205
Actively Recruiting
6
St Elizabeth Healthcare (St Elizabeth Medical Center)
Edgewood, Kentucky, United States, 41017
Actively Recruiting
7
St Elizabeth Healthcare (St Elizabeth Medical
Edgewood, Kentucky, United States, 41017
Actively Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
11
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
12
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
13
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
14
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
15
Northwell Health Cancer Institute - Zuckerberg Cancer Center
Lake Success, New York, United States, 11042
Actively Recruiting
16
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10068
Actively Recruiting
17
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
18
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
19
Thomas Jefferson University Medical Oncology Clinic
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
20
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
21
Gibbs Cancer Center and Research Institute
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
22
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
23
Houston Methodist Hospital/Houston Methodist Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
24
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
25
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
26
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia, 2065
Actively Recruiting
27
Gallipoli Medical Research Foundation (GMRF)
Greenslopes, Queensland, Australia, 4120
Actively Recruiting
28
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
29
Alfred Health
Melbourne, Victoria, Australia, 3004
Actively Recruiting
30
LKH - Universitaetsklinikum Graz
Graz, Austria, 8036
Actively Recruiting
31
Kepler Universitätsklinikum
Linz, Austria, 4020
Actively Recruiting
32
Universitatsklinik fur Innere Medizin 3
Salzburg, Austria, 5020
Actively Recruiting
33
AKH - Medizinische Universität Wien
Vienna, Austria, 1090
Actively Recruiting
34
Cliniques Universitaires Sain-Luc
Brussels, Belgium, 1200
Actively Recruiting
35
UZ Brussel
Jette, Belgium, 1090
Actively Recruiting
36
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
37
BC Cancer
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
38
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
39
Lady Davis Institute for Medical Research (LDI) Jewish General Hospital (JGH)
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
40
Centre Leon Berard
Lyon, Cedex, France, 69373
Actively Recruiting
41
Institute Claudius Regaud
Toulouse, Cedex, France, 31059
Actively Recruiting
42
Institut Gustave Roussy
Villejuif, Cedex, France, 94805
Actively Recruiting
43
CHU de Bordeaux - Hopital Saint Andre
Bordeaux, France, 22075
Actively Recruiting
44
Hopital de la Timone [Recruiting]
Marseille, France, 13005
Actively Recruiting
45
Hopital Saint Lous - APHP
Paris, France, 75010
Actively Recruiting
46
Universitaetsklinikum Schleswig-Holstein
Schleswig, Kiel, Germany, 24105
Actively Recruiting
47
Charité - Campus Charité Mitte
Berlin, Germany, 10115
Actively Recruiting
48
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Actively Recruiting
49
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
50
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
51
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
52
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
53
Universitaetsklinikum Schleswig-Holstein
Kiel, Germany, 24105
Actively Recruiting
54
Johannes Wesling Klinikum Minden
Minden, Germany, 32429
Actively Recruiting
55
LMU-Campus Innenstadt
München, Germany, 80337
Actively Recruiting
56
Universitaetsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
57
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
58
Instituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy, 80131
Actively Recruiting
59
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, Italy, 6156
Actively Recruiting
60
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
61
A.O.U Senese Policlinico Santa Maria alle Scotte
Siena, Italy, 53100
Actively Recruiting
62
Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz, Poland, 85-796
Actively Recruiting
63
Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii
Gdansk, Poland, 80214
Actively Recruiting
64
Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu
Poznan, Poland, 60355
Actively Recruiting
65
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, Poland, 02781
Actively Recruiting
66
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
67
Hospital Clinico de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
68
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
69
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
70
Hospital Regional Universitario de Malaga
Málaga, Spain, 29010
Actively Recruiting
71
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Actively Recruiting
72
Kantonsspital St. Gallen
Sankt Gallen, Switzerland, 9000
Actively Recruiting
73
Universitaetsspital Zurich
Zurich, Switzerland, 8058
Actively Recruiting
74
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
75
The Christie NHS Foundation Trust
Manchester, England, United Kingdom, M20 4BX
Actively Recruiting
76
Queen Elizabeth Hospital
Birmingham, West Midlands, United Kingdom, B15 2TH
Actively Recruiting
77
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
Actively Recruiting
78
Guys & St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
79
Sarah Cannon Research Institute UK
London, United Kingdom, SE1 9RT
Actively Recruiting
80
Royal Marsden Hospital - Chelsea
London, United Kingdom, SW3 6JJ
Actively Recruiting
81
Mount Vernon Cancer Center
Middlesex, United Kingdom, HA6 2RN
Actively Recruiting
82
Royal Marsden Hospital - Sutton
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
I
Immunocore Medical Information
CONTACT
I
Immunocore Medical Information EU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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