RecruitingPhase 3NCT05549297

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

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)

Sponsor

Immunocore Ltd

Enrollment

540 participants

Start Date

Dec 19, 2022

Study Type

INTERVENTIONAL

Conditions

Advanced Melanoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a drug called tebentafusp to other treatment options chosen by the treating doctor, in people with advanced melanoma (non-eye-related) that has been previously treated. Tebentafusp works by directing the immune system to attack melanoma cells. **You may be eligible if...** - You have unresectable (cannot be removed surgically) stage III or IV melanoma that is not from the eye - Your blood type is HLA-A*02:01-positive (a specific genetic marker) - You have had previous treatment for melanoma - You are in good physical condition (ECOG 0–1) - You have a tumor tissue sample available **You may NOT be eligible if...** - You have ocular (eye) or uveal melanoma - You are not HLA-A*02:01-positive - You have had another cancer in the past few years - You are pregnant or breastfeeding - You have serious autoimmune conditions or untreated brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTebentafusp

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

DRUGTebentafusp with Pembrolizumab

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

DRUGInvestigators Choice

Investigators choice of therapy

Locations(82)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

University of Kansas Cancer Center - Westwood

Westwood, Kansas, United States

St Elizabeth Healthcare (St Elizabeth Medical Center)

Edgewood, Kentucky, United States

St Elizabeth Healthcare (St Elizabeth Medical

Edgewood, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Northwell Health Cancer Institute - Zuckerberg Cancer Center

Lake Success, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Thomas Jefferson University Medical Oncology Clinic

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Gibbs Cancer Center and Research Institute

Spartanburg, South Carolina, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Houston Methodist Hospital/Houston Methodist Cancer Center

Houston, Texas, United States

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Melanoma Institute Australia

Wollstonecraft, New South Wales, Australia

Gallipoli Medical Research Foundation (GMRF)

Greenslopes, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Alfred Health

Melbourne, Victoria, Australia

LKH - Universitaetsklinikum Graz

Graz, Austria

Kepler Universitätsklinikum

Linz, Austria

Universitatsklinik fur Innere Medizin 3

Salzburg, Austria

AKH - Medizinische Universität Wien

Vienna, Austria

Cliniques Universitaires Sain-Luc

Brussels, Belgium

UZ Brussel

Jette, Belgium

UZ Leuven

Leuven, Belgium

BC Cancer

Vancouver, British Columbia, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

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

Montreal, Quebec, Canada

Centre Leon Berard

Lyon, Cedex, France

Institute Claudius Regaud

Toulouse, Cedex, France

Institut Gustave Roussy

Villejuif, Cedex, France

CHU de Bordeaux - Hopital Saint Andre

Bordeaux, France

Hopital de la Timone [Recruiting]

Marseille, France

Hopital Saint Lous - APHP

Paris, France

Universitaetsklinikum Schleswig-Holstein

Schleswig, Kiel, Germany

Charité - Campus Charité Mitte

Berlin, Germany

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Universitaetsklinikum Erlangen

Erlangen, Germany

Universitaetsklinikum Essen

Essen, Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Schleswig-Holstein

Kiel, Germany

Johannes Wesling Klinikum Minden

Minden, Germany

LMU-Campus Innenstadt

München, Germany

Universitaetsklinikum Tübingen

Tübingen, Germany

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Instituto Nazionale Tumori Fondazione G. Pascale

Naples, Italy

Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

Perugia, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

A.O.U Senese Policlinico Santa Maria alle Scotte

Siena, Italy

Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy

Bydgoszcz, Poland

Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii

Gdansk, Poland

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

Poznan, Poland

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

Warsaw, Poland

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clinico de Barcelona

Barcelona, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Regional Universitario de Malaga

Málaga, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Universitaetsspital Zurich

Zurich, Switzerland

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

The Christie NHS Foundation Trust

Manchester, England, United Kingdom

Queen Elizabeth Hospital

Birmingham, West Midlands, United Kingdom

Leeds General Infirmary

Leeds, United Kingdom

Guys & St Thomas' NHS Foundation Trust

London, United Kingdom

Sarah Cannon Research Institute UK

London, United Kingdom

Royal Marsden Hospital - Chelsea

London, United Kingdom

Mount Vernon Cancer Center

Middlesex, United Kingdom

Royal Marsden Hospital - Sutton

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05549297

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