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NCT05549297PHASE3Recruiting

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

Immunocore Ltd

Start Date

12/19/2022

Completion Date

7/1/2028

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Tebentafusp

DRUG

Tebentafusp with Pembrolizumab

DRUG

Investigators Choice

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Conditions

Advanced Melanoma

Locations

Mayo Clinic Arizona

Phoenix, Arizona 85054

United States

Mayo Clinic Florida

Jacksonville, Florida 32224

United States

Orlando Health Cancer Institute

Orlando, Florida 32806

United States

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

United States

University of Kansas Cancer Center - Westwood

Westwood, Kansas 66205

United States

St Elizabeth Healthcare (St Elizabeth Medical Center)

Edgewood, Kentucky 41017

United States

St Elizabeth Healthcare (St Elizabeth Medical

Edgewood, Kentucky 41017

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts 02215

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

University of Minnesota Medical Center

Minneapolis, Minnesota 55455

United States

Mayo Clinic Minnesota

Rochester, Minnesota 55905

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

Northwell Health Cancer Institute - Zuckerberg Cancer Center

Lake Success, New York 11042

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10068

United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio 43210

United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma 73104

United States

Thomas Jefferson University Medical Oncology Clinic

Philadelphia, Pennsylvania 19107

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Gibbs Cancer Center and Research Institute

Spartanburg, South Carolina 29303

United States

University of Tennessee Medical Center

Knoxville, Tennessee 37920

United States

Houston Methodist Hospital/Houston Methodist Cancer Center

Houston, Texas 77030

United States

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

Melanoma Institute Australia

Wollstonecraft, New South Wales 2065

Australia

Gallipoli Medical Research Foundation (GMRF)

Greenslopes, Queensland 4120

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland 4102

Australia

Alfred Health

Melbourne, Victoria 3004

Australia

LKH - Universitaetsklinikum Graz

Graz, 8036

Austria

Kepler Universitätsklinikum

Linz, 4020

Austria

Universitatsklinik fur Innere Medizin 3

Salzburg, 5020

Austria

AKH - Medizinische Universität Wien

Vienna, 1090

Austria

Cliniques Universitaires Sain-Luc

Brussels, 1200

Belgium

UZ Brussel

Jette, 1090

Belgium

UZ Leuven

Leuven, 3000

Belgium

BC Cancer

Vancouver, British Columbia V5Z 4E6

Canada

Princess Margaret Hospital

Toronto, Ontario M5G 2M9

Canada

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

Montreal, Quebec H3T 1E2

Canada

Centre Leon Berard

Lyon, Cedex 69373

France

Institute Claudius Regaud

Toulouse, Cedex 31059

France

Institut Gustave Roussy

Villejuif, Cedex 94805

France

CHU de Bordeaux - Hopital Saint Andre

Bordeaux, 22075

France

Hopital de la Timone [Recruiting]

Marseille, 13005

France

Hopital Saint Lous - APHP

Paris, 75010

France

Universitaetsklinikum Schleswig-Holstein

Schleswig, Kiel 24105

Germany

Charité - Campus Charité Mitte

Berlin, 10115

Germany

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307

Germany

Universitaetsklinikum Erlangen

Erlangen, 91054

Germany

Universitaetsklinikum Essen

Essen, 45147

Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246

Germany

Universitaetsklinikum Heidelberg

Heidelberg, 69120

Germany

Universitaetsklinikum Schleswig-Holstein

Kiel, 24105

Germany

Johannes Wesling Klinikum Minden

Minden, 32429

Germany

LMU-Campus Innenstadt

München, 80337

Germany

Universitaetsklinikum Tübingen

Tübingen, 72076

Germany

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133

Italy

Instituto Nazionale Tumori Fondazione G. Pascale

Naples, 80131

Italy

Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

Perugia, 6156

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168

Italy

A.O.U Senese Policlinico Santa Maria alle Scotte

Siena, 53100

Italy

Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy

Bydgoszcz, 85-796

Poland

Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii

Gdansk, 80214

Poland

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

Poznan, 60355

Poland

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

Warsaw, 02781

Poland

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Clinico de Barcelona

Barcelona, 08036

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

Hospital Universitario Ramon y Cajal

Madrid, 28034

Spain

Hospital Regional Universitario de Malaga

Málaga, 29010

Spain

Hospital General Universitario de Valencia

Valencia, 46014

Spain

Kantonsspital St. Gallen

Sankt Gallen, 9000

Switzerland

Universitaetsspital Zurich

Zurich, 8058

Switzerland

Addenbrooke's Hospital

Cambridge, Cambridgeshire CB2 0QQ

United Kingdom

The Christie NHS Foundation Trust

Manchester, England M20 4BX

United Kingdom

Queen Elizabeth Hospital

Birmingham, West Midlands B15 2TH

United Kingdom

Leeds General Infirmary

Leeds, LS1 3EX

United Kingdom

Guys & St Thomas' NHS Foundation Trust

London, SE1 9RT

United Kingdom

Sarah Cannon Research Institute UK

London, SE1 9RT

United Kingdom

Royal Marsden Hospital - Chelsea

London, SW3 6JJ

United Kingdom

Mount Vernon Cancer Center

Middlesex, HA6 2RN

United Kingdom

Royal Marsden Hospital - Sutton

Sutton, SM2 5PT

United Kingdom