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Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
NCT05549297 · Immunocore Ltd
In plain English
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Official title
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)
About this study
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
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* have 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
Study design
Enrollment target: 540 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-12-19
Estimated completion: 2028-07
Last updated: 2026-02-25
Interventions
Drug: TebentafuspDrug: Tebentafusp with PembrolizumabDrug: Investigators Choice
Primary outcomes
- • Overall Survival (OS) (Up to ~4 years)
Sponsor
Immunocore Ltd · industry
Contacts & investigators
ContactImmunocore Medical Information · contact · medical.information@immunocore.com · 844-466-8661
ContactImmunocore Medical Information EU · contact · medinfo.eu@immunocore.com · +00 800-744-51111
All locations (82)
Mayo Clinic ArizonaRecruiting
Phoenix, Arizona, United States
Mayo Clinic FloridaRecruiting
Jacksonville, Florida, United States
Orlando Health Cancer InstituteRecruiting
Orlando, Florida, United States
Winship Cancer Institute of Emory UniversityRecruiting
Atlanta, Georgia, United States
University of Kansas Cancer Center - WestwoodRecruiting
Westwood, Kansas, United States
St Elizabeth Healthcare (St Elizabeth Medical Center)Recruiting
Edgewood, Kentucky, United States
St Elizabeth Healthcare (St Elizabeth MedicalRecruiting
Edgewood, Kentucky, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)Recruiting
Boston, Massachusetts, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
University of Minnesota Medical CenterRecruiting
Minneapolis, Minnesota, United States
Mayo Clinic MinnesotaRecruiting
Rochester, Minnesota, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Rutgers Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
Northwell Health Cancer Institute - Zuckerberg Cancer CenterRecruiting
Lake Success, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
The Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
OU Health Stephenson Cancer CenterRecruiting
Oklahoma City, Oklahoma, United States
Thomas Jefferson University Medical Oncology ClinicRecruiting
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
Gibbs Cancer Center and Research InstituteRecruiting
Spartanburg, South Carolina, United States
University of Tennessee Medical CenterRecruiting
Knoxville, Tennessee, United States
Houston Methodist Hospital/Houston Methodist Cancer CenterRecruiting
Houston, Texas, United States
University of Utah Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
Melanoma Institute AustraliaRecruiting
Wollstonecraft, New South Wales, Australia
Gallipoli Medical Research Foundation (GMRF)Recruiting
Greenslopes, Queensland, Australia
Princess Alexandra HospitalRecruiting
Woolloongabba, Queensland, Australia
Alfred HealthRecruiting
Melbourne, Victoria, Australia
LKH - Universitaetsklinikum GrazRecruiting
Graz, Austria
Kepler UniversitätsklinikumRecruiting
Linz, Austria
Universitatsklinik fur Innere Medizin 3Recruiting
Salzburg, Austria
AKH - Medizinische Universität WienRecruiting
Vienna, Austria
Cliniques Universitaires Sain-LucRecruiting
Brussels, Belgium
UZ BrusselRecruiting
Jette, Belgium
UZ LeuvenRecruiting
Leuven, Belgium
BC CancerRecruiting
Vancouver, British Columbia, Canada
Princess Margaret HospitalRecruiting
Toronto, Ontario, Canada
Lady Davis Institute for Medical Research (LDI) Jewish General Hospital (JGH)Recruiting
Montreal, Quebec, Canada
Centre Leon BerardRecruiting
Lyon, Cedex, France
Institute Claudius RegaudRecruiting
Toulouse, Cedex, France
Institut Gustave RoussyRecruiting
Villejuif, Cedex, France
CHU de Bordeaux - Hopital Saint AndreRecruiting
Bordeaux, France
Hopital de la Timone [Recruiting]Recruiting
Marseille, France
Hopital Saint Lous - APHPRecruiting
Paris, France
Universitaetsklinikum Schleswig-HolsteinRecruiting
Schleswig, Kiel, Germany
Charité - Campus Charité MitteRecruiting
Berlin, Germany
Universitatsklinikum Carl Gustav Carus DresdenRecruiting
Dresden, Germany
Universitaetsklinikum ErlangenRecruiting
Erlangen, Germany
Universitaetsklinikum EssenRecruiting
Essen, Germany
Universitaetsklinikum Hamburg-EppendorfRecruiting
Hamburg, Germany
Universitaetsklinikum HeidelbergRecruiting
Heidelberg, Germany
Universitaetsklinikum Schleswig-HolsteinRecruiting
Kiel, Germany
Johannes Wesling Klinikum MindenRecruiting
Minden, Germany
LMU-Campus InnenstadtRecruiting
München, Germany
Universitaetsklinikum TübingenRecruiting
Tübingen, Germany
Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
Milan, Italy
Instituto Nazionale Tumori Fondazione G. PascaleRecruiting
Naples, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria della MisericordiaRecruiting
Perugia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
Roma, Italy
A.O.U Senese Policlinico Santa Maria alle ScotteRecruiting
Siena, Italy
Centrum Onkologii im. prof. F. Lukaszczyka w BydgoszczyRecruiting
Bydgoszcz, Poland
Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i RadioterapiiRecruiting
Gdansk, Poland
Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w PoznaniuRecruiting
Poznan, Poland
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyRecruiting
Warsaw, Poland
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Hospital Clinico de BarcelonaRecruiting
Barcelona, Spain
Hospital General Universitario Gregorio MarañonRecruiting
Madrid, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Spain
Hospital Regional Universitario de MalagaRecruiting
Málaga, Spain
Hospital General Universitario de ValenciaRecruiting
Valencia, Spain
Kantonsspital St. GallenRecruiting
Sankt Gallen, Switzerland
Universitaetsspital ZurichRecruiting
Zurich, Switzerland
Addenbrooke's HospitalRecruiting
Cambridge, Cambridgeshire, United Kingdom
The Christie NHS Foundation TrustRecruiting
Manchester, England, United Kingdom
Queen Elizabeth HospitalRecruiting
Birmingham, West Midlands, United Kingdom
Leeds General InfirmaryRecruiting
Leeds, United Kingdom
Guys & St Thomas' NHS Foundation TrustRecruiting
London, United Kingdom
Sarah Cannon Research Institute UKRecruiting
London, United Kingdom
Royal Marsden Hospital - ChelseaRecruiting
London, United Kingdom
Mount Vernon Cancer CenterRecruiting
Middlesex, United Kingdom
Royal Marsden Hospital - SuttonRecruiting
Sutton, United Kingdom