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NCT06112314PHASE3Recruiting

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

Immunocore Ltd

Start Date

6/5/2024

Completion Date

10/16/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participants must be HLA-A\*02:01-positive * Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma * Archived or fresh tumor tissue sample that must be confirmed as adequate * Participants must have measurable disease per RECIST 1.1 * Participant must have BRAF V600 mutation status determined * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention Exclusion Criteria: * Participants with a history of a malignant disease other than those being treated in this study * Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis * Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients * Participants with clinically significant pulmonary disease or impaired lung function * Participants with clinically significant cardiac disease or impaired cardiac function * Participants with active autoimmune disease requiring immunosuppressive treatment * Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results * Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma * Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3

Interventions

DRUG

Brenetafusp

DRUG

Nivolumab

DRUG

Nivolumab + Relatlimab

Interested in This Trial?

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Conditions

Advanced Melanoma

Locations

University of Arizona

Tucson, Arizona 85720

United States

University of California - San Diego

La Jolla, California 92093-0698

United States

The Angeles Clinic and Research Institute- West Los Angeles

Los Angeles, California 90025

United States

ESC Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

UCLA Hematology/Oncology

Los Angeles, California 90095

United States

Stanford Cancer Institute - Stanford Cancer Center Palo Alto

Palo Alto, California 94304

United States

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

Santa Monica, California 90404

United States

University of Colorado, Anschutz Medical Campus

Aurora, Colorado 80045

United States

The Melanoma & Skin Cancer Institute

Denver, Colorado 80222

United States

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

Farmington, Connecticut 06030-2205

United States

Georgetown University

Washington D.C., District of Columbia 20007

United States

Mayo Clinic Florida

Jacksonville, Florida 32224

United States

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

Miami, Florida 33136

United States

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

Chicago, Illinois 60611

United States

The University of Kansas Cancer Center (KUCC) - Westwood

Westwood, Kansas 66205

United States

St. Elizabeth Healthcare - Edgewood

Edgewood, Kentucky 41017

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Henry Ford Cancer Center - Michigan

Detroit, Michigan 04820

United States

Allina Health Cancer Institute - Minneapolis

Minneapolis, Minnesota 55407

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Northwell Health Cancer Institute

Lake Success, New York 11042

United States

Columbia University Medical Center

New York, New York 10032

United States

The Ohio State University

Columbus, Ohio 43210

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Prisma Health Cancer Institute

Greenville, South Carolina 29605

United States

Spartanburg Regional Healthcare System - Spartanburg Medical Center (SMC)

Spartanburg, South Carolina 29303

United States

The University of Tennessee - Knoxville (UTK)

Knoxville, Tennessee 37920

United States

Sarah Cannon Research Institute: USA/TN

Nashville, Tennessee 37203

United States

Tennessee Oncology, PLLC

Nashville, Tennessee 37203

United States

University of Texas Southwestern

Dallas, Texas 75235-9179

United States

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

UVA Health-UVA Emily Couric Clinical Cancer Center

Charlottesville, Virginia 22903

United States

Virginia Commonwealth University (VCU) - Massey Cancer Center

Richmond, Virginia 23298-0070

United States

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

Seattle, Washington 98104

United States

Sanatorio Finochietto

Caba, Buenos Aires 1213

Argentina

Clínica Adventista Belgrano - Sector Investigación

Caba, Buenos Aires C1430EGF

Argentina

Hospital Italiano de Buenos Aires (HIBA)

Buenos Aires, C1199ABD

Argentina

Instituto Alexander Fleming

CABA, CP1426ANZ

Argentina

CEMAIC (Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, X5008HHW

Argentina

Clinica Viedma

Viedma, R8500ACE

Argentina

Calvary Mater Newcastle Hospital

Waratah, New South Wales 02298

Australia

Gallipoli Medical Research Foundation (Greenslopes Private Hospital)

Greenslopes, Queensland 4120

Australia

Linear Clinical Research

Nedlands, Western Australia 06009

Australia

One Clinical Research - Nedlands

Nedlands, Western Australia 06009

Australia

Austin Hospital

Heidelberg, 3084

Australia

Peter MacCallum Cancer Centre

North Melbourne, 3051

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, 8036

Austria

Universitätsklinikum St. Pölten

Pölten,

Austria

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

Salzburg, 5020

Austria

AKH - Medizinische Universität Wien

Vienna, 1090

Austria

Universite Libre de Bruxelles (ULB)-Institut Jules Bordet

Anderlecht, 01070

Belgium

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

Bruges, 8000

Belgium

Universitair Ziekenhuis Brussel

Brussels, 1090

Belgium

Cliniques Universitaires Saint-Luc - Institut Roi Albert II

Brussels, 1200

Belgium

UZ Leuven

Leuven, 03000

Belgium

Centro de Pesquisa Clinica em Oncologia - Oncosite

Ijuí, Rio Grande do Sul 98700-000

Brazil

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

Porto Alegre, Rio Grande do Sul 90110-270

Brazil

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

Barretos, 14784

Brazil

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

Brasília, DF CEP 70200-730

Brazil

Centro de Pesquisas Oncologicas (CEPON)

Florianópolis, 88034-000

Brazil

Oncocentro Sao Carlos Hospital

Fortaleza, 60135-237

Brazil

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

Liberdade, 01509-010

Brazil

Hospital de Clinicas de Porto Alegre (HCPA)

Porto Alegre, 90035-903

Brazil

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

Porto Alegre, 90610-000

Brazil

National Cancer Institute

Rio de Janeiro, 20220-410

Brazil

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

Rio de Janeiro, 22775-001

Brazil

Instituto do Cancer do Estado de Sao Paulo (ICESP)

São Paulo, 01246-000

Brazil

Hospital 9 de Julho

São Paulo, 01308-070

Brazil

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

São Paulo, 15090-000

Brazil

Uni Hospital

Panagyurishte, 4500

Bulgaria

Complex Oncology Center - Plovdiv Ltd.

Plovdiv, 4000

Bulgaria

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

Sofia, 1527

Bulgaria

Regina Life Clinic

Sofia,

Bulgaria

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2C1

Canada

Cross Cancer Institute

Edmonton, T6G 1Z2

Canada

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

Hradec Králové, 500 05

Czechia

Fakultni Nemocnice Olomouc (FNOL)

Olomouc, 77900

Czechia

Sanatorium Profesora Arenbergera

Prague, 110 00

Czechia

Kobenhavns Universitet - Herlev Hospital (Amtssygehuset i Herlev)

Herlev, 2730

Denmark

Helsingin Yliopistollinen Keskussairaala - Cancercentrum

Helsinki, 00290

Finland

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

Tampere, 33520

Finland

Turun Yliopistollinen Keskussairaala (TYKS)

Turku, 20520

Finland

Hôpital de la Timone

Marseille, Cedex 13385

France

Oncopole Claudius Regaud- Institut Universitaire du Cancer de Toulouse

Toulouse, Cedex 31059

France

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

Bobigny, 93000

France

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

Boulogne-Billancourt, 92104

France

UNICANCER-Centre Francois Baclesse (CFB)

Caen, 14000

France

CHU de Dijon Bourgogne - Hôpital François Mitterrand

Dijon,

France

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

Lille, 59037

France

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

Nantes,

France

Hospital Saint Louis

Paris, 75010

France

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

Pierre-Bénite, 69310

France

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

Rouen, 76031

France

Hopital Robert Debre

Valence, 26000

France

Institut Gustave Roussy (IGR) Service de Dermatolgie

Villejuif, 94800

France

Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Dermatologie Venerologie und Allergologie - Hauttumorcentrum Charite (HTCC)

Berlin, 10115

Germany

Klinikum Bremen-Ost gGmbH

Bremen, 28205

Germany

Klinikum Dortmund gGmbH - Klinikzentrum Mitte - Hautklinik

Dortmund, 44137

Germany

Universitätsklinikum Carl Gustav Carus

Dresden, 01307

Germany

Helios Klinikum Erfurt - Klinik fuer Hautkrankheiten und Allergologie

Erfurt, 99089

Germany

Universitaetsklinikum Erlangen

Erlangen, 91054

Germany

Universitaetsklinikum Essen

Essen, 45122

Germany

Johann Wolfgang Goethe-Universitaet Frankfurt am Main - Klinik fuer Dermatologie, Venerologie und Allergologie

Frankfurt, 60590

Germany

Justus-Liebig-Universitaet Giessen - Klinik fuer Dermatologie und Andrologie

Giessen, D-35392

Germany

University of Hamburg

Hamburg, 20246

Germany

Elbe Kliniken Stade - Hautkrebszentrum Buxtehude

Hamburg, 22045

Germany

Universitaetsklinikum Heidelberg (UKHD) - Hautklinik

Heidelberg, 69120

Germany

University Hospital Schleswig-Holstein

Kiel, DE-24105

Germany

Universitaetsklinikum Leipzig - Klinik fuer Dermatologie, Venerologie und Allergologie

Leipzig, 4103

Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, D-55131

Germany

Universitaetsklinikum Giessen und Marburg GmbH - Marburg

Marburg, 35043

Germany

Johannes Wesling Klinikum Minden

Minden, 32429

Germany

LMU Klinikum - Klinik und Poliklinik fur Dermatologie und Allergologie

Munich, 81377

Germany

Universitaetsklinikum Tuebingen (UKT) - Zentrum fuer Dermatoonkologie - Hautklinik

Tübingen, 72076

Germany

Universitaetsklinikum Wuerzburg - Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie

Würzburg, 97080

Germany

Semmelweis Egyetem Általános Orvostudományi Kar

Budapest, 1085

Hungary

Orszagos Onkologiai Intezet (National Institute of Oncology)

Budapest, 1122

Hungary

Debreceni Egyetem-Klinikai Kozpont (DEKK)

Debrecen,

Hungary

Pecsi Tudomanyegyetem (PTE) (University of Pecs)

Pécs, 7624

Hungary

Szegedi Tudomanyegyetem (University of Szeged)

Szeged, 6720

Hungary

Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari

Bari, 70124

Italy

Humanitas Gavazzeni (Cliniche Gavazzeni S.p.A)

Bergamo, 24125

Italy

IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST)

Meldola, 47014

Italy

Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)

Milan, 20141

Italy

Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano

Milan, 20133

Italy

Azienda Ospedaliero-Universitaria di Modena (AOU Modena) - Policlinico di Modena - Day Hospital Oncologico

Modena, 41124

Italy

Istituto Nazionale Tumori (INT) "Fondazione G. Pascale" di Napoli

Naples, 80131

Italy

Istituto Oncologico Veneto (IOV) IRCCS

Padova, 35128

Italy

Istituto Oncologico Veneto (IOV) IRCCS

Padova, I-35128

Italy

Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

Perugia, 06129

Italy

Azienda Sanitaria Locale di Biella (ASL BI) - Ospedale degli Infermi

Ponderano, 13875

Italy

National Cancer Institute Regina Elena

Roma, 00128

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 0168

Italy

" Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte - Clinica Immunoterapia Oncologica"

Siena, 53100

Italy

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Torino, 10126

Italy

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, 50161

Lithuania

Vilnius University Hospital Santaros Clinics Affiliate National Cancer Center

Vilnius, LT-08406

Lithuania

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco 44280

Mexico

Centro Oncologico Internacional(COI) - Ciudad de Mexico

Mexico City, 04701

Mexico

Haukeland University Hospital

Bergen, 05009

Norway

Oslo University Hospital

Oslo, 0379

Norway

Centrum Onkologii im. Prof. Franciszka Łukaszczyka

Bydgoszcz, 85796

Poland

Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214

Poland

Centrum Medyczne Pratia Poznań - Skorzewo

Skorzewo, 60185

Poland

Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków

Warsaw, 02-781

Poland

Centro Hospitalar e Universitario de Coimbra EPE (CHUC)

Coimbra, 3004-561

Portugal

Instituto Portugues de Oncologio de Lisboa Francisco Gentil EPE (IPO Lisboa) (IPOLFG)

Lisbon, 1099-023

Portugal

Hospital Lusiadas Lisboa (HPP Hospital Dos Lusiadas)

Lisbon, 1649-035

Portugal

L'Institute Oncologique Prof. Dr. Ion Chiricuta (IOCN) (The Oncology Institute Prof. Dr. Ion. Chiricuta)

Cluj-Napoca, 400015

Romania

Sf Nectarie Oncology Center

Craiova, 200542

Romania

Victoria Hospital (Centrul de oncologie Euroclinic SRL) (Centrul De Oncologie Medicala) (Euroclinic Onchology Center)

Iași, 700106

Romania

Universidad de Cantabria (UC) - Hospital Universitario Marques de Valdecilla (HUMV)

Santander, Cantabria 39008

Spain

Universidad de Murcia - Hospital Universitario Virgen de la Arrixaca (HUVA)

El Palmar, Murcia 30120

Spain

Complejo Hospitalario Universitario A Coruna (CHUAC)

A Coruña, 15006

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Universitario Dexeus

Barcelona, 08035

Spain

Hospital Duran i Reynals

Barcelona, 08908

Spain

Hospital Clinic de Barcelona

Barcelona, 8036

Spain

Hospital Universitario Reina Sofia

Córdoba, 14004

Spain

Hospital Universitario Virgen de las Nieves (HUVN)

Granada, 18014

Spain

Hospital Universitario Insular De Gran Canaria

Las Palmas de Gran Canaria, 35016

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28009

Spain

Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid

Madrid, 28027

Spain

Hospital Universitario Ramon y Cajal

Madrid, 28034

Spain

Universidad Complutense de Madrid (UCM)-Hospital Universitario 12 de Octubre (H12O)

Madrid, 28041

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Centro Integral Oncologico Clara Campal (CIOCC)

Madrid, 28050

Spain

Hospital Regional Universitario de Malaga

Málaga, 29016

Spain

Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona

Pamplona, 31008

Spain

Hospital Universitari Sant Joan de Reus

Reus, 43204

Spain

Onkologikoa - Kutxaren Institutu Onkologikoa (Instituto Oncologico De Guipuzcoa)

San Sebastián, 20014

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Hospital Universitario Virgen del Rocio

Seville, 41013

Spain

Instituto de Investigacion Sanitaria (INCLIVA) (Institute of Health Research Hospital Clinic of Valencia)

Valencia, 46010

Spain

Hospital Clinico Universitario de Valencia

Valencia, 46014

Spain

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

Valencia, 46026

Spain

Servicio Aragones de Salud - Hospital Universitario Miguel Servet (HUMS)

Zaragoza, 50009

Spain

Sahlgrenska Akademin - Institutionen for Kliniska Vetenskaper (Institute of Clinical Sciences)

Gothenburg, SE41345

Sweden

Lanssjukhuset Ryhov - Onkologiska Kliniken

Jönköping, 553 05

Sweden

Skanes Universitetssjukhus - Lund - Onkologiska Klinik

Lund, 22185

Sweden

Karolinska Universitetssjukhuset

Stockholm, 171 76

Sweden

Uppsala Universitet - Akademiska Sjukhuset (Uppsala University Hospital)

Uppsala, SE75185

Sweden

UniversitaetsSpital Zuerich - Dermatologische Klinik

Zurich, 8901

Switzerland

T.C. Saglik Bakanligi - Adana Numune Egitim ve Arastirma Hastanesi (Adana Numune Education and Research Hospital)

Yüreğir, Adana 1370

Turkey (Türkiye)

Memorial Saglik Grubu - Memorial Ankara Hastanesi

Çankaya, Ankara 06520

Turkey (Türkiye)

Memorial Antalya Hastanesi

Kepez, Antalya 7025

Turkey (Türkiye)

Medical Park Hastaneler Grubu - I.A.U. VM Medical Park Florya

Antalya, Campus 07070

Turkey (Türkiye)

Medical Park Gaziantep Hastanesi

Şehitkamil, Gaziantep 27584

Turkey (Türkiye)

Memorial Saglik Grubu - Memorial Bahcelievler Hastanesi

Bahçelievler, Istanbul 34180

Turkey (Türkiye)

Ege Universitesi Tip Fakultesi (Ege University Faculty of Medicine)

Bornova, İzmir 35100

Turkey (Türkiye)

Izmir Ekonomi Universitesi Medikal Point Hastanesi

Cordaleo, İzmir 35575

Turkey (Türkiye)

Kanser Enstitusu (Hacettepe University Cancer Institute)

Altındağ, 6230

Turkey (Türkiye)

T.C. Saglik Bakanligi - SBU Gulhane Egitim ve Arastirma Hastanesi

Ankara, 6100

Turkey (Türkiye)

Ankara Bilkent City Hospital, Oncology Department

Çankaya, 6800

Turkey (Türkiye)

Inonu Universitesi - Turgut Ozal Tip Merkezi

Malatya, 44280

Turkey (Türkiye)

Ondokuz Mayis Universitesi (OMU) - Tip Facultesi

Samsun, 55270

Turkey (Türkiye)

Medical Park Seyhan Hastanesi

Seyhan, 1140

Turkey (Türkiye)

T.C. Saglik Bakanligi - Ankara Etlik sehir Hastanesi

Yenimahalle, 06170

Turkey (Türkiye)

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2TH

United Kingdom

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH) - Oncology Centre

Cambridge, CB20QQ

United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN

United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, L78YA

United Kingdom

Sarah Cannon Research Institute (SCRI) - London (SCRI-UK)

London, W1G 6AD

United Kingdom

The Christie NHS Foundation Trust

Manchester, M204BX

United Kingdom

University of Oxford

Oxford, Ox37LE

United Kingdom

Royal Marsden Hospital - Sutton

Surrey Quays, SM2 5PT

United Kingdom