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Advanced MelanomaPhase 3NCT05549297

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

A Phase 3 study testing Tebentafusp, Tebentafusp with Pembrolizumab and Investigators Choice in people with Advanced Melanoma, run by Immunocore Ltd at 82 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Melanoma
What is being tested?
Tebentafusp, Tebentafusp with Pembrolizumab and Investigators Choice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
82 sitesin 12 countries
Study dates
19 Dec 2022to Jul 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 21Show fewer
  • 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

Trial locations and contacts

82 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Immunocore Medical Information contact

844-466-8661

medical.information@immunocore.com

Immunocore Medical Information EU contact

+00 800-744-51111

medinfo.eu@immunocore.com

82 sites in 12 countries

United States25 sites, 25 recruiting

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts, 02215

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Recruiting

  • St Elizabeth Healthcare (St Elizabeth Medical Center)

    Edgewood, Kentucky, 41017

    Recruiting

  • St Elizabeth Healthcare (St Elizabeth Medical

    Edgewood, Kentucky, 41017

    Recruiting

  • Houston Methodist Hospital/Houston Methodist Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

    Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

    Recruiting

  • Northwell Health Cancer Institute - Zuckerberg Cancer Center

    Lake Success, New York, 11042

    Recruiting

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10068

    Recruiting

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

    Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

    Recruiting

  • Thomas Jefferson University Medical Oncology Clinic

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Mayo Clinic Minnesota

    Rochester, Minnesota, 55905

    Recruiting

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Recruiting

  • Gibbs Cancer Center and Research Institute

    Spartanburg, South Carolina, 29303

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Recruiting

  • University of Kansas Cancer Center - Westwood

    Westwood, Kansas, 66205

    Recruiting

Other trials in United States

Germany11 sites, 11 recruiting

  • Charité - Campus Charité Mitte

    Berlin, 10115

    Recruiting

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

    Recruiting

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

    Recruiting

  • Universitaetsklinikum Essen

    Essen, 45147

    Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

    Recruiting

  • Universitaetsklinikum Schleswig-Holstein

    Kiel, 24105

    Recruiting

  • Johannes Wesling Klinikum Minden

    Minden, 32429

    Recruiting

  • LMU-Campus Innenstadt

    München, 80337

    Recruiting

  • Universitaetsklinikum Schleswig-Holstein

    Schleswig, Kiel, 24105

    Recruiting

  • Universitaetsklinikum Tübingen

    Tübingen, 72076

    Recruiting

Other trials in Germany

United Kingdom9 sites, 9 recruiting

  • Queen Elizabeth Hospital

    Birmingham, West Midlands, B15 2TH

    Recruiting

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

    Recruiting

  • Leeds General Infirmary

    Leeds, LS1 3EX

    Recruiting

  • Guys & St Thomas' NHS Foundation Trust

    London, SE1 9RT

    Recruiting

  • Sarah Cannon Research Institute UK

    London, SE1 9RT

    Recruiting

  • Royal Marsden Hospital - Chelsea

    London, SW3 6JJ

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, England, M20 4BX

    Recruiting

  • Mount Vernon Cancer Center

    Middlesex, HA6 2RN

    Recruiting

  • Royal Marsden Hospital - Sutton

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

France6 sites, 6 recruiting

  • CHU de Bordeaux - Hopital Saint Andre

    Bordeaux, 22075

    Recruiting

  • Centre Leon Berard

    Lyon, Cedex, 69373

    Recruiting

  • Hopital de la Timone [Recruiting]

    Marseille, 13005

    Recruiting

  • Hopital Saint Lous - APHP

    Paris, 75010

    Recruiting

  • Institute Claudius Regaud

    Toulouse, Cedex, 31059

    Recruiting

  • Institut Gustave Roussy

    Villejuif, Cedex, 94805

    Recruiting

Other trials in France

Spain6 sites, 6 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinico de Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

    Recruiting

  • Hospital General Universitario de Valencia

    Valencia, 46014

    Recruiting

Other trials in Spain

Italy5 sites, 5 recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Recruiting

  • Instituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131

    Recruiting

  • Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

    Perugia, 6156

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

    Recruiting

  • A.O.U Senese Policlinico Santa Maria alle Scotte

    Siena, 53100

    Recruiting

Other trials in Italy

Australia4 sites, 4 recruiting

  • Gallipoli Medical Research Foundation (GMRF)

    Greenslopes, Queensland, 4120

    Recruiting

  • Alfred Health

    Melbourne, Victoria, 3004

    Recruiting

  • Melanoma Institute Australia

    Wollstonecraft, New South Wales, 2065

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Recruiting

Other trials in Australia

Austria4 sites, 4 recruiting

  • LKH - Universitaetsklinikum Graz

    Graz, 8036

    Recruiting

  • Kepler Universitätsklinikum

    Linz, 4020

    Recruiting

  • Universitatsklinik fur Innere Medizin 3

    Salzburg, 5020

    Recruiting

  • AKH - Medizinische Universität Wien

    Vienna, 1090

    Recruiting

Other trials in Austria

Poland4 sites, 4 recruiting

  • Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85-796

    Recruiting

  • Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii

    Gdansk, 80214

    Recruiting

  • Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu

    Poznan, 60355

    Recruiting

  • Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

    Warsaw, 02781

    Recruiting

Other trials in Poland

Belgium3 sites, 3 recruiting

  • Cliniques Universitaires Sain-Luc

    Brussels, 1200

    Recruiting

  • UZ Brussel

    Jette, 1090

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Recruiting

Other trials in Belgium

Canada3 sites, 3 recruiting

  • Lady Davis Institute for Medical Research (LDI) Jewish General Hospital (JGH)

    Montreal, Quebec, H3T 1E2

    Recruiting

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

    Recruiting

  • BC Cancer

    Vancouver, British Columbia, V5Z 4E6

    Recruiting

Other trials in Canada

Switzerland2 sites, 2 recruiting

  • Kantonsspital St. Gallen

    Sankt Gallen, 9000

    Recruiting

  • Universitaetsspital Zurich

    Zurich, 8058

    Recruiting

Other trials in Switzerland

About this study

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)

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.

Read the 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.

Being tested
Tebentafusp, Tebentafusp with Pembrolizumab, Investigators Choice
Keywords
Melanoma, IMCgp100, Tebentafusp, Cutaneous Melanoma, Immunotherapy, gp100, TCR, Pembrolizumab, Bispecific T cell receptor fusion protein, ImmTAC (Immune-mobilizing monoclonal T-cell receptor Against Cancer), Immune mobilizing monoclonal T cell receptor against cancer, KIMMTRAK, Acral Melanoma, Mucosal Melanoma, Blue Nevus, anti-PDL1, checkpoint therapy
Medical subject headings
Melanoma, Nevus, Blue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TebentafuspDrug

    Soluble gp100-specific T cell receptor with anti-CD3 scFV

  • Tebentafusp with PembrolizumabDrug

    Soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with pembrolizumab

  • Investigators ChoiceDrug

    Investigators choice of therapy

Study groups in NCT05549297
Study groupRoleWhat they receive
Arm A: Tebentafusp MonotherapyExperimentalParticipants receive tebentafusp as single agent.
Receives: Drug: Tebentafusp
Arm B: Tebentafusp + PembrolizumabExperimentalParticipants receive tebentafusp in combination with pembrolizumab.
Receives: Drug: Tebentafusp with Pembrolizumab
Arm C: Investigator's ChoiceExperimentalParticipants receive investigator's choice of therapy.
Receives: Drug: Investigators Choice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS is the time from randomization to death due to any cause.

    Measured: Up to ~4 years

Secondary outcomes (9)

  1. Change from Baseline in Circulating Tumor DNS (ctDNA)

    Change from baseline in ctDNA will be assessed.

    Measured: Up to ~9 weeks

  2. Number of participants with ≥1 adverse event (AE)

    Number of participants with AEs.

    Measured: Up to ~4 years

  3. Number of participants with ≥1 serious adverse event (SAEs)

    Number of participants with SAEs.

    Measured: Up to ~4 years

  4. Number of participants with dose interruptions, reductions, and discontinuations from study therapy due to AEs

    Number of participants with tolerability issues.

    Measured: Up to ~4 years

  5. Number of participants with Grade ≥2 cytokine release syndrome (CRS)

    CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria.

    Measured: Up to ~4 years

  6. Responses to the EORTC Core Quality of Life (EORTC-QLQ-C30)

    Participant-reported quality of life.

    Measured: At designated time points up to ~4 years

  7. Responses to the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)

    Participant-reported quality of life.

    Measured: At designated time points up to ~4 years

  8. Plasma Concentration of Tebentafusp

    Plasma concentration of tebentafusp.

    Measured: At designated time points up to ~4 years

  9. Number of participants with anti-tebentafusp antibodies

    The number of participants with anti drug antibodies (ADA) to tebentafusp.

    Measured: At designated time points up to ~4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2022
  2. Study start19 Dec 2022
  3. Primary completionMar 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05549297
Sponsor's protocol ID
IMCgp100-203
Status last verified
Feb 2026
First submitted
26 Aug 2022
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tebentafusp, Tebentafusp with Pembrolizumab and Investigators Choice in people with Advanced Melanoma, run by Immunocore Ltd at 82 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Germany, United Kingdom, France, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Immunocore Medical Information (844-466-8661, medical.information@immunocore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to ~4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05549297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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