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New combo therapy aims to extend life in advanced melanoma

NCT ID NCT05549297

Disease control Sponsor: Immunocore Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug, tebentafusp, alone or with pembrolizumab, in people with a specific genetic type (HLA-A*02:01) of advanced melanoma that has been treated before. The main goal is to see if these treatments help people live longer compared to other available options. About 540 participants will be enrolled.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 540 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

blue nevus melanoma metastatic melanoma non-cutaneous melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    82 sites in 12 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

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

    RECRUITING

    Siena, 53100, Italy

  • AKH - Medizinische Universität Wien

    RECRUITING

    Vienna, 1090, Austria

  • Addenbrooke's Hospital

    RECRUITING

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • Alfred Health

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

    RECRUITING

    Perugia, 6156, Italy

  • BC Cancer

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Beth Israel Deaconess Medical Center (BIDMC)

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • CHU de Bordeaux - Hopital Saint Andre

    RECRUITING

    Bordeaux, 22075, France

  • Centre Leon Berard

    RECRUITING

    Lyon, Cedex, 69373, France

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

    RECRUITING

    Bydgoszcz, 85-796, Poland

  • Charité - Campus Charité Mitte

    RECRUITING

    Berlin, 10115, Germany

  • Cliniques Universitaires Sain-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Gallipoli Medical Research Foundation (GMRF)

    RECRUITING

    Greenslopes, Queensland, 4120, Australia

  • Gibbs Cancer Center and Research Institute

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • Guys & St Thomas' NHS Foundation Trust

    RECRUITING

    London, SE1 9RT, United Kingdom

  • Hopital Saint Lous - APHP

    RECRUITING

    Paris, 75010, France

  • Hopital de la Timone [Recruiting]

    RECRUITING

    Marseille, 13005, France

  • Hospital Clinico de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Marañon

    RECRUITING

    Madrid, 28007, Spain

  • Hospital General Universitario de Valencia

    RECRUITING

    Valencia, 46014, Spain

  • Hospital Regional Universitario de Malaga

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Houston Methodist Hospital/Houston Methodist Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, Cedex, 94805, France

  • Institute Claudius Regaud

    RECRUITING

    Toulouse, Cedex, 31059, France

  • Instituto Nazionale Tumori Fondazione G. Pascale

    RECRUITING

    Naples, 80131, Italy

  • Johannes Wesling Klinikum Minden

    RECRUITING

    Minden, 32429, Germany

  • Kantonsspital St. Gallen

    RECRUITING

    Sankt Gallen, 9000, Switzerland

  • Kepler Universitätsklinikum

    RECRUITING

    Linz, 4020, Austria

  • LKH - Universitaetsklinikum Graz

    RECRUITING

    Graz, 8036, Austria

  • LMU-Campus Innenstadt

    RECRUITING

    München, 80337, Germany

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

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Leeds General Infirmary

    RECRUITING

    Leeds, LS1 3EX, United Kingdom

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Minnesota

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Melanoma Institute Australia

    RECRUITING

    Wollstonecraft, New South Wales, 2065, Australia

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10068, United States

  • Mount Vernon Cancer Center

    RECRUITING

    Middlesex, HA6 2RN, United Kingdom

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

    RECRUITING

    Warsaw, 02781, Poland

  • Northwell Health Cancer Institute - Zuckerberg Cancer Center

    RECRUITING

    Lake Success, New York, 11042, United States

  • OU Health Stephenson Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Orlando Health Cancer Institute

    RECRUITING

    Orlando, Florida, 32806, United States

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Princess Margaret Hospital

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Queen Elizabeth Hospital

    RECRUITING

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • Royal Marsden Hospital - Chelsea

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • Royal Marsden Hospital - Sutton

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Sarah Cannon Research Institute UK

    RECRUITING

    London, SE1 9RT, United Kingdom

  • St Elizabeth Healthcare (St Elizabeth Medical

    RECRUITING

    Edgewood, Kentucky, 41017, United States

  • St Elizabeth Healthcare (St Elizabeth Medical Center)

    RECRUITING

    Edgewood, Kentucky, 41017, United States

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

    RECRUITING

    Poznan, 60355, Poland

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, England, M20 4BX, United Kingdom

  • The Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Thomas Jefferson University Medical Oncology Clinic

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • UZ Brussel

    RECRUITING

    Jette, 1090, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitaetsklinikum Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • Universitaetsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • Universitaetsklinikum Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Schleswig-Holstein

    RECRUITING

    Schleswig, Kiel, 24105, Germany

  • Universitaetsklinikum Schleswig-Holstein

    RECRUITING

    Kiel, 24105, Germany

  • Universitaetsklinikum Tübingen

    RECRUITING

    Tübingen, 72076, Germany

  • Universitaetsspital Zurich

    RECRUITING

    Zurich, 8058, Switzerland

  • Universitatsklinik fur Innere Medizin 3

    RECRUITING

    Salzburg, 5020, Austria

  • Universitatsklinikum Carl Gustav Carus Dresden

    RECRUITING

    Dresden, 01307, Germany

  • University of Kansas Cancer Center - Westwood

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Minnesota Medical Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Tennessee Medical Center

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • University of Utah Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

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

    RECRUITING

    Gdansk, 80214, Poland

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute of Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.