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Clinical Trials in the UK / NCT05549297
Recruiting Phase 3

Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)

NCT05549297 · tracked via the Priya Life Science UK tracker
Sponsor
Immunocore Ltd
Phase
Phase 3
Started
2022-12-19
Last updated
2026-02-25

Condition(s) studied

Advanced Melanoma

Investigational drug(s) / intervention(s)

TebentafuspTebentafusp with PembrolizumabInvestigators Choice

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (82)

FacilityCityRegionStatus
Mayo Clinic Arizona Phoenix Arizona Recruiting
Mayo Clinic Florida Jacksonville Florida Recruiting
Orlando Health Cancer Institute Orlando Florida Recruiting
Winship Cancer Institute of Emory University Atlanta Georgia Recruiting
University of Kansas Cancer Center - Westwood Westwood Kansas Recruiting
St Elizabeth Healthcare (St Elizabeth Medical Center) Edgewood Kentucky Recruiting
St Elizabeth Healthcare (St Elizabeth Medical Edgewood Kentucky Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Beth Israel Deaconess Medical Center (BIDMC) Boston Massachusetts Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
University of Minnesota Medical Center Minneapolis Minnesota Recruiting
Mayo Clinic Minnesota Rochester Minnesota Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey Recruiting
Northwell Health Cancer Institute - Zuckerberg Cancer Center Lake Success New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
The Ohio State University Comprehensive Cancer Center Columbus Ohio Recruiting
OU Health Stephenson Cancer Center Oklahoma City Oklahoma Recruiting
Thomas Jefferson University Medical Oncology Clinic Philadelphia Pennsylvania Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
Gibbs Cancer Center and Research Institute Spartanburg South Carolina Recruiting
University of Tennessee Medical Center Knoxville Tennessee Recruiting
Houston Methodist Hospital/Houston Methodist Cancer Center Houston Texas Recruiting
University of Utah Huntsman Cancer Institute Salt Lake City Utah Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
Melanoma Institute Australia Wollstonecraft New South Wales Recruiting
Gallipoli Medical Research Foundation (GMRF) Greenslopes Queensland Recruiting
Princess Alexandra Hospital Woolloongabba Queensland Recruiting
Alfred Health Melbourne Victoria Recruiting
LKH - Universitaetsklinikum Graz Graz Austria Recruiting
Kepler Universitätsklinikum Linz Austria Recruiting
Universitatsklinik fur Innere Medizin 3 Salzburg Austria Recruiting
AKH - Medizinische Universität Wien Vienna Austria Recruiting
Cliniques Universitaires Sain-Luc Brussels Belgium Recruiting
UZ Brussel Jette Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
BC Cancer Vancouver British Columbia Recruiting
Princess Margaret Hospital Toronto Ontario Recruiting
Lady Davis Institute for Medical Research (LDI) Jewish General Hospital (JGH) Montreal Quebec Recruiting
Centre Leon Berard Lyon Cedex Recruiting

+ 42 more sites — see the full list on the official registry below.

More Immunocore Ltd trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05549297 on ClinicalTrials.gov ↗ ← All trials in the UK