Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
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)
1 other identifier
interventional
540
11 countries
78
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2022
Longer than P75 for phase_3
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedStudy Start
First participant enrolled
December 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
February 25, 2026
February 1, 2026
5.2 years
August 26, 2022
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Up to ~4 years
Secondary Outcomes (9)
Change from Baseline in Circulating Tumor DNS (ctDNA)
Up to ~9 weeks
Number of participants with ≥1 adverse event (AE)
Up to ~4 years
Number of participants with ≥1 serious adverse event (SAEs)
Up to ~4 years
Number of participants with dose interruptions, reductions, and discontinuations from study therapy due to AEs
Up to ~4 years
Number of participants with Grade ≥2 cytokine release syndrome (CRS)
Up to ~4 years
- +4 more secondary outcomes
Study Arms (3)
Arm A: Tebentafusp Monotherapy
EXPERIMENTALParticipants receive tebentafusp as single agent.
Arm B: Tebentafusp + Pembrolizumab
EXPERIMENTALParticipants receive tebentafusp in combination with pembrolizumab.
Arm C: Investigator's Choice
EXPERIMENTALParticipants receive investigator's choice of therapy.
Interventions
Soluble gp100-specific T cell receptor with anti-CD3 scFV
Soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with pembrolizumab
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnant or lactating women
- 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
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Immunocore Ltdlead
Study Sites (82)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2022
First Posted
September 22, 2022
Study Start
December 19, 2022
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
February 25, 2026
Record last verified: 2026-02