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

February 23, 2026 updated by: Immunocore Ltd

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
540

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Wollstonecraft, New South Wales, Australia, 2065
        • Recruiting
        • Melanoma Institute Australia
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Recruiting
        • Gallipoli Medical Research Foundation (GMRF)
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Alfred Health
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Lkh - Universitaetsklinikum Graz
      • Linz, Austria, 4020
        • Recruiting
        • Kepler Universitätsklinikum
      • Salzburg, Austria, 5020
        • Recruiting
        • Universitatsklinik fur Innere Medizin 3
      • Vienna, Austria, 1090
        • Recruiting
        • AKH - Medizinische Universität Wien
  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Sain-Luc
      • Jette, Belgium, 1090
        • Recruiting
        • UZ Brussel
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BC Cancer
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Lady Davis Institute for Medical Research (LDI) Jewish General Hospital (JGH)
  • France
      • Bordeaux, France, 22075
        • Recruiting
        • CHU de Bordeaux - Hopital Saint André
      • Marseille, France, 13005
        • Recruiting
        • Hopital de la Timone [Recruiting]
      • Paris, France, 75010
        • Recruiting
        • Hopital Saint Lous - APHP
    • Cedex
      • Lyon, Cedex, France, 69373
        • Recruiting
        • Centre Léon Bérard
      • Toulouse, Cedex, France, 31059
        • Recruiting
        • Institute Claudius Regaud
      • Villejuif, Cedex, France, 94805
        • Recruiting
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, 10115
        • Recruiting
        • Charité - Campus Charité Mitte
      • Dresden, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus Dresden
      • Erlangen, Germany, 91054
        • Recruiting
        • Universitaetsklinikum Erlangen
      • Essen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitaetsklinikum Hamburg-Eppendorf
      • Heidelberg, Germany, 69120
        • Recruiting
        • Universitaetsklinikum Heidelberg
      • Kiel, Germany, 24105
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein
      • Minden, Germany, 32429
        • Recruiting
        • Johannes Wesling Klinikum Minden
      • München, Germany, 80337
        • Recruiting
        • LMU-Campus Innenstadt
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tubingen
    • Kiel
      • Schleswig, Kiel, Germany, 24105
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein
  • Italy
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Napoli, Italy, 80131
        • Recruiting
        • Instituto Nazionale Tumori Fondazione G. Pascale
      • Perugia, Italy, 6156
        • Recruiting
        • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Siena, Italy, 53100
        • Recruiting
        • A.O.U Senese Policlinico Santa Maria alle Scotte
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy
      • Gdansk, Poland, 80214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii
      • Poznan, Poland, 60355
        • Recruiting
        • Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu
      • Warsaw, Poland, 02781
        • Recruiting
        • Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clínico de Barcelona
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Málaga
      • Valencia, Spain, 46014
        • Recruiting
        • Hospital General Universitario de Valencia
  • Switzerland
      • Sankt Gallen, Switzerland, 9000
        • Recruiting
        • Kantonsspital St. Gallen
      • Zurich, Switzerland, 8058
        • Recruiting
        • Universitaetsspital Zürich
  • United Kingdom
      • Leeds, United Kingdom, LS1 3EX
        • Recruiting
        • Leeds General Infirmary
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden Hospital - Chelsea
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guys & St Thomas' NHS Foundation Trust
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Sarah Cannon Research Institute UK
      • Middlesex, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon Cancer Center
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital - Sutton
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Recruiting
        • Addenbrooke's Hospital
    • England
      • Manchester, England, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Recruiting
        • Queen Elizabeth Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Arizona
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Florida
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Cancer Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute of Emory University
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Cancer Center - Westwood
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • St Elizabeth Healthcare (St Elizabeth Medical Center)
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • St Elizabeth Healthcare (St Elizabeth Medical
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center (Bidmc)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota Medical Center
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Minnesota
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health Cancer Institute - Zuckerberg Cancer Center
      • New York, New York, United States, 10068
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Comprehensive Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health Stephenson Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Medical Oncology Clinic
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Gibbs Cancer Center and Research Institute
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • University of Tennessee Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital/Houston Methodist Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: Tebentafusp Monotherapy
Participants receive tebentafusp as single agent.
Drug: Tebentafusp
Soluble gp100-specific T cell receptor with anti-CD3 scFV
Experimental: Arm B: Tebentafusp + Pembrolizumab
Participants receive tebentafusp in combination with pembrolizumab.
Drug: Tebentafusp with Pembrolizumab
Soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with pembrolizumab
Experimental: Arm C: Investigator's Choice
Participants receive investigator's choice of therapy.
Drug: Investigators Choice
Investigators choice of therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to ~4 years
OS is the time from randomization to death due to any cause.
Up to ~4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Circulating Tumor DNS (ctDNA)
Time Frame: Up to ~9 weeks
Change from baseline in ctDNA will be assessed.
Up to ~9 weeks
Number of participants with ≥1 adverse event (AE)
Time Frame: Up to ~4 years
Number of participants with AEs.
Up to ~4 years
Number of participants with ≥1 serious adverse event (SAEs)
Time Frame: Up to ~4 years
Number of participants with SAEs.
Up to ~4 years
Number of participants with dose interruptions, reductions, and discontinuations from study therapy due to AEs
Time Frame: Up to ~4 years
Number of participants with tolerability issues.
Up to ~4 years
Number of participants with Grade ≥2 cytokine release syndrome (CRS)
Time Frame: Up to ~4 years
CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Up to ~4 years
Responses to the EORTC Core Quality of Life (EORTC-QLQ-C30)
Time Frame: At designated time points up to ~4 years
Participant-reported quality of life.
At designated time points up to ~4 years
Responses to the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Time Frame: At designated time points up to ~4 years
Participant-reported quality of life.
At designated time points up to ~4 years
Plasma Concentration of Tebentafusp
Time Frame: At designated time points up to ~4 years
Plasma concentration of tebentafusp.
At designated time points up to ~4 years
Number of participants with anti-tebentafusp antibodies
Time Frame: At designated time points up to ~4 years
The number of participants with anti drug antibodies (ADA) to tebentafusp.
At designated time points up to ~4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Immunocore Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mohammed Dar, MD, Immunocore Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMCgp100-203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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