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

Last updated: December 4, 2024
Sponsor: Immunocore Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Metastatic Melanoma

Melanoma

Treatment

IMC-F106C

Nivolumab + Relatlimab

Brenetafusp

Clinical Study ID

NCT06112314
IMC-F106C-301
2023-505306-42-00
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Participants must be HLA-A*02:01-positive

  • Participants must have histologically confirmed Stage IV or unresectable Stage IIImelanoma

  • 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) performancestatus score of 0 or 1

  • Male and female participants of childbearing potential who are sexually active witha non-sterilized partner must agree to use highly effective methods of birth controlfrom the study screening date until 5 months after the final dose of studyintervention

Exclusion

Exclusion Criteria:

  • Participants with a history of a malignant disease other than those being treated inthis 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 cardiacfunction

  • Participants with active autoimmune disease requiring immunosuppressive treatment

  • Participants with any medical condition that is poorly controlled or that would, inthe Investigator's or Sponsor's judgment, adversely impact the participant'sparticipation in the clinical study due to safety concerns, compliance with clinicalstudy procedures, or interpretation of study results

  • Participants who received prior systemic anticancer therapy for unresectable ormetastatic melanoma

  • Participants with a history of a life-threatening AE related to prior anti-PD-(L)1or anti-LAG-3

Study Design

Total Participants: 680
Treatment Group(s): 4
Primary Treatment: IMC-F106C
Phase: 3
Study Start date:
June 05, 2024
Estimated Completion Date:
October 16, 2027

Connect with a study center

  • Clínica Adventista Belgrano - Sector Investigación

    Caba, Buenos Aires C1430EGF
    Argentina

    Active - Recruiting

  • Sanatorio Finochietto

    Caba, Buenos Aires 1213
    Argentina

    Active - Recruiting

  • Instituto Alexander Fleming

    Buenos Aires,
    Argentina

    Site Not Available

  • Instituto Alexander Fleming

    Caba, CP1426ANZ
    Argentina

    Active - Recruiting

  • Clinica Viedma

    Viedma, R8500ACE
    Argentina

    Active - Recruiting

  • Gallipoli Medical Research Foundation (Greenslopes Private Hospital)

    Greenslopes, Queensland 4120
    Australia

    Active - Recruiting

  • Austin Hospital

    Heidelberg, 3084
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    North Melbourne, 3051
    Australia

    Active - Recruiting

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

    Wollstonecraft,
    Australia

    Active - Recruiting

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

    Woolloongabba,
    Australia

    Active - Recruiting

  • Universitätsklinikum St. Pölten

    Pölten,
    Austria

    Active - Recruiting

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

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Universitätsklinikum St. Pölten

    St. Poelten,
    Austria

    Site Not Available

  • Cliniques Universitaires Saint-Luc, Medical Oncology

    Brussels,
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Brussel

    Brussels,
    Belgium

    Site Not Available

  • Universitaire Ziekenhuizen (UZ) Leuven - General Medical Oncology

    Leuven,
    Belgium

    Site Not Available

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

    Barretos, 14784
    Brazil

    Active - Recruiting

  • Centro de Pesquisas Oncologicas (CEPON)

    Florianópolis, 88034-000
    Brazil

    Active - Recruiting

  • Oncosite

    Ijuí,
    Brazil

    Site Not Available

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

    Porto Alegre, 90610-000
    Brazil

    Active - Recruiting

  • Instituto Nacional de Cancer (INCA) (Brazilian National Cancer Institute)

    Rio De Janeiro,
    Brazil

    Site Not Available

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

    Rio de Janeiro,
    Brazil

    Site Not Available

  • Instituto do Cancer do Estado de Sao Paulo (ICESP)

    São Paulo, 01246-000
    Brazil

    Active - Recruiting

  • Uni Hospital

    Panagyurishte, 4500
    Bulgaria

    Active - Recruiting

  • Complex Oncology Center - Plovdiv Ltd.

    Plovdiv, 4000
    Bulgaria

    Active - Recruiting

  • Regina Life Clinic

    Sofia,
    Bulgaria

    Active - Recruiting

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

    Sofia, 1527
    Bulgaria

    Active - Recruiting

  • University of Alberta - Cross Cancer Institute

    Edmonton,
    Canada

    Site Not Available

  • UHN - Princess Margaret Cancer Centre, University Health Network

    Toronto,
    Canada

    Site Not Available

  • Sanatorium Profesora Arenbergera

    Praha, 110 00
    Czechia

    Active - Recruiting

  • Kobenhavns Universitet - Herlev Hospital (Amtssygehuset i Herlev)

    Herlev, 2730
    Denmark

    Active - Recruiting

  • Hôpital de la Timone

    Marseille, Cedex 13385
    France

    Active - Recruiting

  • Oncopole Claudius Regaud- Institut Universitaire du Cancer de Toulouse

    Toulouse, Cedex 31059
    France

    Active - Recruiting

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

    Bobigny, 93000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre

    Bordeaux,
    France

    Site Not Available

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

    Boulogne-Billancourt, 92104
    France

    Active - Recruiting

  • Assistance Publique-Hôpitaux de Paris (AP-HP)

    Boulogne-Billancourt,
    France

    Site Not Available

  • CHU de Dijon Bourgogne - Hôpital François Mitterrand

    Dijon,
    France

    Active - Recruiting

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

    Lille, 59037
    France

    Active - Recruiting

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille,
    France

    Site Not Available

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

    Nantes,
    France

    Active - Recruiting

  • Assistance Publique - Hôpitaux de Paris - Hôpital Saint-Louis - Centre d'Onco-Dermatologie

    Paris,
    France

    Site Not Available

  • Hospital Saint Louis

    Paris, 75010
    France

    Active - Recruiting

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

    Pierre-Benite, 69310
    France

    Active - Recruiting

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

    Rouen, 76031
    France

    Active - Recruiting

  • Institut Claudius Regaud - Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)

    Toulouse,
    France

    Site Not Available

  • Hopital Robert Debre

    Valence, 26000
    France

    Active - Recruiting

  • Institut Gustave Roussy (IGR) Service de Dermatolgie

    Villejuif, 94800
    France

    Active - Recruiting

  • Institut de Cancerologie Gustave-Roussy

    Villejuif,
    France

    Site Not Available

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

    Berlin, 10115
    Germany

    Active - Recruiting

  • Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus

    Dresden,
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, 45122
    Germany

    Active - Recruiting

  • Universitaetsklinikum Essen - Klinik und Poliklinik fuer Dermatologie, Venerologie und Allergologie

    Essen,
    Germany

    Site Not Available

  • Elbe Kliniken Stade - Hautkrebszentrum Buxtehude

    Hamburg, 22045
    Germany

    Active - Recruiting

  • University Medical Center Hamburg-Eppendorf (UKE)

    Hamburg,
    Germany

    Site Not Available

  • University of Hamburg

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Universitaetsklinikum Heidelberg (UKHD) - Hautklinik

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig,
    Germany

    Site Not Available

  • Universitaetsklinikum Leipzig - Klinik fuer Dermatologie, Venerologie und Allergologie

    Leipzig, 4103
    Germany

    Active - Recruiting

  • Johannes Wesling Klinikum Minden

    Minden, 32429
    Germany

    Active - Recruiting

  • Johannes Wesling Medical Center

    Minden,
    Germany

    Site Not Available

  • Universitaetsklinikum Tuebingen (UKT) - Zentrum fuer Dermatoonkologie - Hautklinik

    Tübingen, 72076
    Germany

    Active - Recruiting

  • Universitaetsklinikum Wuerzburg - Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie

    Würzburg, 97080
    Germany

    Active - Recruiting

  • Semmelweis Egyetem Általános Orvostudományi Kar

    Budapest, 1085
    Hungary

    Active - Recruiting

  • Pecsi Tudomanyegyetem (PTE) (University of Pecs)

    Pécs, 7624
    Hungary

    Active - Recruiting

  • Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari

    Bari, 70124
    Italy

    Active - Recruiting

  • Humanitas Gavazzeni (Cliniche Gavazzeni S.p.A)

    Bergamo, 24125
    Italy

    Active - Recruiting

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

    Meldola, 47014
    Italy

    Active - Recruiting

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

    Milan, 20141
    Italy

    Active - Recruiting

  • Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano

    Milano,
    Italy

    Site Not Available

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

    Napoli, 80131
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"

    Napoli,
    Italy

    Site Not Available

  • Istituto Oncologico Veneto (IOV) IRCCS

    Padova, I-35128
    Italy

    Active - Recruiting

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

    Ponderano, 13875
    Italy

    Active - Recruiting

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

    Siena, 53100
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Senese - Istituto Toscano Tumori (ITT) - Siena

    Siena,
    Italy

    Site Not Available

  • Hospital Hispano Investigacion Clinica

    Guadalajara,
    Mexico

    Site Not Available

  • Centrum Onkologii im. Prof. Franciszka Łukaszczyka

    Bydgoszcz, 85796
    Poland

    Active - Recruiting

  • Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214
    Poland

    Active - Recruiting

  • Centrum Medyczne Pratia Poznań - Skorzewo

    Skorzewo, 60185
    Poland

    Active - Recruiting

  • Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków

    Warszawa, 02-781
    Poland

    Active - Recruiting

  • Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

    Warszawa,
    Poland

    Site Not Available

  • Institutul Oncologic " Prof. Dr. Ion Chiricuta" Str. (IOCN)

    Cluj-Napoca,
    Romania

    Site Not Available

  • Sf Nectarie Oncology Center

    Craiova, 200542
    Romania

    Active - Recruiting

  • Sf Nectarie Oncology Center, Oncology Department

    Craiova,
    Romania

    Site Not Available

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

    El Palmar, Murcia 30120
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario A Coruna (CHUAC)

    A Coruña, 15006
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 8036
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Dexeus

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Institut Català d'Oncologia (ICO) - Hospital Duran i Reynals

    Barcelona,
    Spain

    Site Not Available

  • Instituto Oncologico Dr. Rosell (IOR) Hospital Universitario Dexeus

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de las Nieves (HUVN)

    Granada, 18014
    Spain

    Active - Recruiting

  • Centro Integral Oncologico Clara Campal (CIOCC)

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañon (HGUGM)

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz (HULP)

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Civil (Hospital Regional Universitario de Malaga)

    Malaga,
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Sevilla,
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46014
    Spain

    Active - Recruiting

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

    Göteborg, SE41345
    Sweden

    Active - Recruiting

  • Karolinska Universitetssjukhuset

    Stockholm, 171 76
    Sweden

    Active - Recruiting

  • Uppsala Universitet - Akademiska Sjukhuset (Uppsala University Hospital)

    Uppsala, SE75185
    Sweden

    Active - Recruiting

  • UniversitaetsSpital Zuerich - Dermatologische Klinik

    Zurich, 8901
    Switzerland

    Active - Recruiting

  • UniversitaetsSpital Zuerich - Dermatologische Klinik

    Zürich,
    Switzerland

    Site Not Available

  • Kanser Enstitusu (Hacettepe University Cancer Institute)

    Altındağ, 6230
    Turkey

    Active - Recruiting

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

    Ankara, 6100
    Turkey

    Active - Recruiting

  • Ankara Bilkent City Hospital, Oncology Department

    Çankaya, 6800
    Turkey

    Active - Recruiting

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

    Cambridge, CB20QQ
    United Kingdom

    Active - Recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN
    United Kingdom

    Active - Recruiting

  • The Clatterbridge Cancer Centre (CCC) NHS Foundation Trust (Clatterbridge Centre for Oncology NHS Foundation Trust) - Clatterbridge Cancer Centre - Aintree

    Liverpool,
    United Kingdom

    Site Not Available

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, L78YA
    United Kingdom

    Active - Recruiting

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

    London, W1G 6AD
    United Kingdom

    Active - Recruiting

  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - London

    London,
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester, M204BX
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust - The Christie Clinic

    Manchester,
    United Kingdom

    Site Not Available

  • East and North Hertfordshire NHS Trust - Mount Vernon Hospital - Mount Vernon Cancer Centre (MVCC)

    Northwood,
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Trust - Churchill Hospital

    Oxford,
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital - Sutton

    Surrey Quays, SM2 5PT
    United Kingdom

    Active - Recruiting

  • University of California San Diego (UCSD) - Moores Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • ESC Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • The Angeles Clinic and Research Institute - West Los Angeles - The Melanoma Center

    Los Angeles, California 90025
    United States

    Site Not Available

  • The Angeles Clinic and Research Institute- West Los Angeles

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • UCLA Hematology/Oncology

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center

    San Francisco, California 94143
    United States

    Site Not Available

  • UCLA Department of Medicine- Hematology/Oncology

    Westwood, California 90024
    United States

    Site Not Available

  • University of Colorado Hospital (UCH) - Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado, Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Georgetown University Medical Center (GUMC)

    Washington, District of Columbia 20007-2113
    United States

    Site Not Available

  • Mayo Clinic Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Moffitt Cancer Center - Magnolia Campus

    Tampa, Florida 33612
    United States

    Site Not Available

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

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Northwell Health Cancer Institute

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • Columbia University - Herbert Irving Comprehensive Cancer Center

    New York, New York 10032
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Providence Portland Medical Center

    Portland, Oregon 97213-2933
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

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

    Seattle, Washington 98104
    United States

    Active - Recruiting

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