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IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Sponsor: Immunocore Ltd
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
Conditions
Interventions
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.
Nivolumab
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
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