IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
NCT ID: NCT06112314
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
680 participants
INTERVENTIONAL
2024-06-05
2027-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Brenetafusp Low Dose + Nivolumab
Participants receive brenetafusp Low Dose once weekly (QW) for the first 13 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W). Nivolumab is given Q4W.
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.
Arm B: Brenetafusp High Dose + Nivolumab
Participants receive brenetafusp High Dose once weekly (QW) for the first 13 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W). Nivolumab is given Q4W.
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.
Arm C: Nivolumab OR Nivolumab + Relatlimab
Participants receive nivolumab 480 mg monotherapy, or nivolumab 480 mg + relatlimab 160 mg, Q4W.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Immunocore Ltd
INDUSTRY
Responsible Party
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Locations
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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
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
Dana Farber Cancer Institute
Boston, Massachusetts, 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
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
Sarah Cannon Research Institute: USA/TN
Nashville, Tennessee, 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
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
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
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
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
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Dermatologie Venerologie und Allergologie - Hauttumorcentrum Charite (HTCC)
Berlin, , Germany
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Helios Klinikum Erfurt - Klinik fuer Hautkrankheiten und Allergologie
Erfurt, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Johann Wolfgang Goethe-Universitaet Frankfurt am Main - Klinik fuer Dermatologie, Venerologie und Allergologie
Frankfurt, , Germany
Justus-Liebig-Universitaet Giessen - Klinik fuer Dermatologie und Andrologie
Giessen, , Germany
University of Hamburg
Hamburg, , Germany
Elbe Kliniken Stade - Hautkrebszentrum Buxtehude
Hamburg, , Germany
Universitaetsklinikum Heidelberg (UKHD) - Hautklinik
Heidelberg, , Germany
Universitaetsklinikum Leipzig - Klinik fuer Dermatologie, Venerologie und Allergologie
Leipzig, , Germany
Johannes Wesling Klinikum Minden
Minden, , Germany
LMU Klinikum - Klinik und Poliklinik fur Dermatologie und Allergologie
Munich, , Germany
Universitaetsklinikum Tuebingen (UKT) - Zentrum fuer Dermatoonkologie - Hautklinik
Tübingen, , Germany
Universitaetsklinikum Wuerzburg - Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie
Würzburg, , Germany
Semmelweis Egyetem Általános Orvostudományi Kar
Budapest, , Hungary
Pecsi Tudomanyegyetem (PTE) (University of Pecs)
Pécs, , Hungary
Szegedi Tudomanyegyetem (University of Szeged)
Szeged, , Hungary
Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari
Bari, , Italy
Humanitas Gavazzeni (Cliniche Gavazzeni S.p.A)
Bergamo, , Italy
IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST)
Meldola, , Italy
Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)
Milan, , Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano
Milan, , Italy
Istituto Nazionale Tumori (INT) "Fondazione G. Pascale" di Napoli
Napoli, , Italy
Istituto Oncologico Veneto (IOV) IRCCS
Padua, , Italy
Istituto Oncologico Veneto (IOV) IRCCS
Padua, , Italy
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Perugia, , Italy
Azienda Sanitaria Locale di Biella (ASL BI) - Ospedale degli Infermi
Ponderano, , Italy
National Cancer Institute Regina Elena
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
" Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte - Clinica Immunoterapia Oncologica"
Siena, , Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, , Italy
Haukeland University Hospital
Bergen, , Norway
Oslo University Hospital
Oslo, , Norway
Centrum Onkologii im. Prof. Franciszka Łukaszczyka
Bydgoszcz, , Poland
Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Centrum Medyczne Pratia Poznań - Skorzewo
Skorzewo, , Poland
Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków
Warsaw, , Poland
L'Institute Oncologique Prof. Dr. Ion Chiricuta (IOCN) (The Oncology Institute Prof. Dr. Ion. Chiricuta)
Cluj-Napoca, , Romania
Sf Nectarie Oncology Center
Craiova, , Romania
Victoria Hospital (Centrul de oncologie Euroclinic SRL) (Centrul De Oncologie Medicala) (Euroclinic Onchology Center)
Iași, , Romania
Universidad de Cantabria (UC) - Hospital Universitario Marques de Valdecilla (HUMV)
Santander, Cantabria, Spain
Universidad de Murcia - Hospital Universitario Virgen de la Arrixaca (HUVA)
El Palmar, Murcia, Spain
Complejo Hospitalario Universitario A Coruna (CHUAC)
A Coruña, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Dexeus
Barcelona, , Spain
Hospital Duran i Reynals
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Virgen de las Nieves (HUVN)
Granada, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Universidad Complutense de Madrid (UCM)-Hospital Universitario 12 de Octubre (H12O)
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
Pamplona, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Instituto de Investigacion Sanitaria (INCLIVA) (Institute of Health Research Hospital Clinic of Valencia)
Valencia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, , Spain
Servicio Aragones de Salud - Hospital Universitario Miguel Servet (HUMS)
Zaragoza, , Spain
Sahlgrenska Akademin - Institutionen for Kliniska Vetenskaper (Institute of Clinical Sciences)
Gothenburg, , Sweden
Lanssjukhuset Ryhov - Onkologiska Kliniken
Jönköping, , Sweden
Skanes Universitetssjukhus - Lund - Onkologiska Klinik
Lund, , Sweden
Karolinska Universitetssjukhuset
Stockholm, , Sweden
Uppsala Universitet - Akademiska Sjukhuset (Uppsala University Hospital)
Uppsala, , Sweden
UniversitaetsSpital Zuerich - Dermatologische Klinik
Zurich, , Switzerland
Memorial Saglik Grubu - Memorial Ankara Hastanesi
Çankaya, Ankara, Turkey (Türkiye)
Medical Park Hastaneler Grubu - I.A.U. VM Medical Park Florya
Antalya, Campus, Turkey (Türkiye)
Medical Park Gaziantep Hastanesi
Şehitkamil, Gaziantep, Turkey (Türkiye)
Memorial Saglik Grubu - Memorial Bahcelievler Hastanesi
Bahçelievler, Istanbul, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi (Ege University Faculty of Medicine)
Bornova, İzmir, Turkey (Türkiye)
Izmir Ekonomi Universitesi Medikal Point Hastanesi
Cordaleo, İzmir, Turkey (Türkiye)
Kanser Enstitusu (Hacettepe University Cancer Institute)
Altındağ, , Turkey (Türkiye)
T.C. Saglik Bakanligi - SBU Gulhane Egitim ve Arastirma Hastanesi
Ankara, , Turkey (Türkiye)
Ankara Bilkent City Hospital, Oncology Department
Çankaya, , Turkey (Türkiye)
Inonu Universitesi - Turgut Ozal Tip Merkezi
Malatya, , Turkey (Türkiye)
Ondokuz Mayis Universitesi (OMU) - Tip Facultesi
Samsun, , Turkey (Türkiye)
Medical Park Seyhan Hastanesi
Seyhan, , Turkey (Türkiye)
T.C. Saglik Bakanligi - Ankara Etlik sehir Hastanesi
Yenimahalle, , Turkey (Türkiye)
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH) - Oncology Centre
Cambridge, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, , United Kingdom
Sarah Cannon Research Institute (SCRI) - London (SCRI-UK)
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Royal Marsden Hospital - Sutton
Surrey Quays, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Dr. John Walker, MD
Role: primary
Daniela Walther
Role: primary
Role: primary
Manuel Sánchez Ostos
Role: primary
Role: backup
Role: backup
Hakan Harputluoglu
Role: primary
Other Identifiers
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2023-505306-42
Identifier Type: OTHER
Identifier Source: secondary_id
IMC-F106C-301
Identifier Type: -
Identifier Source: org_study_id
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