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RECRUITING
NCT06112314
PHASE3

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Sponsor: Immunocore Ltd

View on ClinicalTrials.gov

Summary

This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma.

Official title: A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

680

Start Date

2024-06-05

Completion Date

2027-10-16

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

DRUG

Brenetafusp

Soluble PRAME-specific T cell receptor with anti-CD3 scFV concentrate for solution for intravenous (IV) infusion at a unit dose of 0.2 mg/mL.

DRUG

Nivolumab

Concentrate for solution for infusion at a unit dose of 10 mg/mL.

DRUG

Nivolumab + Relatlimab

Concentrate for solution for infusion at a unit dose of 16 mg/mL.

Locations (211)

University of Arizona

Tucson, Arizona, United States

University of California - San Diego

La Jolla, California, United States

The Angeles Clinic and Research Institute- West Los Angeles

Los Angeles, California, United States

ESC Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCLA Hematology/Oncology

Los Angeles, California, United States

Stanford Cancer Institute - Stanford Cancer Center Palo Alto

Palo Alto, California, United States

Saint John's Health Center - John Wayne Cancer Institute (JWCI)

Santa Monica, California, United States

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, United States

The Melanoma & Skin Cancer Institute

Denver, Colorado, United States

UConn Health-Farmington (University of Connecticut Health Center (UCHC))

Farmington, Connecticut, United States

Georgetown University

Washington D.C., District of Columbia, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

University of Miami Health System-Sylvester Comprehensive Cancer Center-Miami

Miami, Florida, United States

Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI

Chicago, Illinois, United States

The University of Kansas Cancer Center (KUCC) - Westwood

Westwood, Kansas, United States

St. Elizabeth Healthcare - Edgewood

Edgewood, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Cancer Center - Michigan

Detroit, Michigan, United States

Allina Health Cancer Institute - Minneapolis

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Northwell Health Cancer Institute

Lake Success, New York, United States

Columbia University Medical Center

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Prisma Health Cancer Institute

Greenville, South Carolina, United States

Spartanburg Regional Healthcare System - Spartanburg Medical Center (SMC)

Spartanburg, South Carolina, United States

The University of Tennessee - Knoxville (UTK)

Knoxville, Tennessee, United States

Sarah Cannon Research Institute: USA/TN

Nashville, Tennessee, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

University of Texas Southwestern

Dallas, Texas, United States

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, United States

UVA Health-UVA Emily Couric Clinical Cancer Center

Charlottesville, Virginia, United States

Virginia Commonwealth University (VCU) - Massey Cancer Center

Richmond, Virginia, United States

Swedish Medical Center - Swedish Cancer Institute (SCI) - First Hill Campus

Seattle, Washington, United States

Sanatorio Finochietto

Caba, Buenos Aires, Argentina

Clínica Adventista Belgrano - Sector Investigación

Caba, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires (HIBA)

Buenos Aires, Argentina

Instituto Alexander Fleming

CABA, Argentina

CEMAIC (Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, Argentina

Clinica Viedma

Viedma, Argentina

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

Gallipoli Medical Research Foundation (Greenslopes Private Hospital)

Greenslopes, Queensland, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

One Clinical Research - Nedlands

Nedlands, Western Australia, Australia

Austin Hospital

Heidelberg, Australia

Peter MacCallum Cancer Centre

North Melbourne, Australia

University of Sydney - Melanoma Institute Australia (MIA) - The Poche Centre

Wollstonecraft, Australia

The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)

Woolloongabba, Australia

LKH - Universitaetsklinikum Graz

Graz, Austria

Universitätsklinikum St. Pölten

Pölten, Austria

Paracelsus Medizinischen Privatuniversitaet - SALK - Universitaetsklinik fuer Dermatologie - EB-Haus Austria

Salzburg, Austria

AKH - Medizinische Universität Wien

Vienna, Austria

Universite Libre de Bruxelles (ULB)-Institut Jules Bordet

Anderlecht, Belgium

AZ Sint-Jan Brugge-Oostende AV-Campus Sint-Jan

Bruges, Belgium

Universitair Ziekenhuis Brussel

Brussels, Belgium

Cliniques Universitaires Saint-Luc - Institut Roi Albert II

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Centro de Pesquisa Clinica em Oncologia - Oncosite

Ijuí, Rio Grande do Sul, Brazil

Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Ltda

Porto Alegre, Rio Grande do Sul, Brazil

Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor

Barretos, Brazil

Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia

Brasília, Brazil

Centro de Pesquisas Oncologicas (CEPON)

Florianópolis, Brazil

Oncocentro Sao Carlos Hospital

Fortaleza, Brazil

A.C.Camargo Cancer Center - Centro Internacional de Pesquisa (CIPE)

Liberdade, Brazil

Hospital de Clinicas de Porto Alegre (HCPA)

Porto Alegre, Brazil

Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Hospital Sao Lucas - Centro de Pesquisa Clinica (CPC)

Porto Alegre, Brazil

National Cancer Institute

Rio de Janeiro, Brazil

Instituto Américas - Instituto de Educação Pesquisa e Gestão em Saúde Oncosite

Rio de Janeiro, Brazil

Instituto do Cancer do Estado de Sao Paulo (ICESP)

São Paulo, Brazil

Hospital 9 de Julho

São Paulo, Brazil

Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP) - Hospital de Base (HB) - Centro Integrado de Pesquisa (CIP)

São Paulo, Brazil

Uni Hospital

Panagyurishte, Bulgaria

Complex Oncology Center - Plovdiv Ltd.

Plovdiv, Bulgaria

University Hospital Tsaritsa Yoanna (ISUL) (Queen Giovanna University Hospital)

Sofia, Bulgaria

Regina Life Clinic

Sofia, Bulgaria

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Cross Cancer Institute

Edmonton, Canada

Fakultni Nemocnice Hradec Kralove (FNHK) - Klinika Onkologie a Radioterapie

Hradec Králové, Czechia

Fakultni Nemocnice Olomouc (FNOL)

Olomouc, Czechia

Sanatorium Profesora Arenbergera

Prague, Czechia

Kobenhavns Universitet - Herlev Hospital (Amtssygehuset i Herlev)

Herlev, Denmark

Helsingin Yliopistollinen Keskussairaala - Cancercentrum

Helsinki, Finland

Pirkanmaan Sairaanhoitopiiri (Pirkanmaa Hospital District)-Tampereen Yliopistollinen Sairaala (Tampere University Hospital)

Tampere, Finland

Turun Yliopistollinen Keskussairaala (TYKS)

Turku, Finland

Hôpital de la Timone

Marseille, Cedex, France

Oncopole Claudius Regaud- Institut Universitaire du Cancer de Toulouse

Toulouse, Cedex, France

Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Seine-Saint-Denis - Hopital Avicenne

Bobigny, France

Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Ambroise-Pare

Boulogne-Billancourt, France

UNICANCER-Centre Francois Baclesse (CFB)

Caen, France

CHU de Dijon Bourgogne - Hôpital François Mitterrand

Dijon, France

Centre Hospitalier Universitaire de Lille (CHU Lille)-Hopital Claude Huriez

Lille, France

Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu

Nantes, France

Hospital Saint Louis

Paris, France

Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Hopital Charles-Nicolle

Rouen, France

Hopital Robert Debre

Valence, France

Institut Gustave Roussy (IGR) Service de Dermatolgie

Villejuif, France

And 111 more locations on ClinicalTrials.gov