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
Status: Recruiting
Location: See all (171) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
University of Arizona
RECRUITING
Tucson
California
University of California - San Diego
RECRUITING
La Jolla
ESC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
The Angeles Clinic and Research Institute- West Los Angeles
RECRUITING
Los Angeles
UCLA Hematology/Oncology
RECRUITING
Los Angeles
Stanford Cancer Institute - Stanford Cancer Center Palo Alto
RECRUITING
Palo Alto
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
RECRUITING
Santa Monica
Colorado
University of Colorado, Anschutz Medical Campus
RECRUITING
Aurora
Connecticut
UConn Health-Farmington (University of Connecticut Health Center (UCHC))
RECRUITING
Farmington
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Florida
Mayo Clinic Florida
RECRUITING
Jacksonville
University of Miami Health System-Sylvester Comprehensive Cancer Center-Miami
RECRUITING
Miami
Illinois
Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI
RECRUITING
Chicago
Kansas
The University of Kansas Cancer Center (KUCC) - Westwood
RECRUITING
Westwood
Kentucky
St. Elizabeth Healthcare - Edgewood
RECRUITING
Edgewood
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Missouri
Washington University School of Medicine
COMPLETED
St Louis
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
RECRUITING
Hackensack
New York
Northwell Health Cancer Institute
RECRUITING
Lake Success
Columbia University Medical Center
COMPLETED
New York
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
South Carolina
Prisma Health Cancer Institute
RECRUITING
Greenville
Spartanburg Regional Healthcare System - Spartanburg Medical Center (SMC)
RECRUITING
Spartanburg
Tennessee
Sarah Cannon Research Institute: USA/TN
RECRUITING
Nashville
Utah
University of Utah Huntsman Cancer Institute
RECRUITING
Salt Lake City
Virginia
UVA Health-UVA Emily Couric Clinical Cancer Center
RECRUITING
Charlottesville
Washington
Swedish Medical Center - Swedish Cancer Institute (SCI) - First Hill Campus
RECRUITING
Seattle
Other Locations
Argentina
Clínica Adventista Belgrano - Sector Investigación
RECRUITING
Caba
Instituto Alexander Fleming
RECRUITING
Caba
Sanatorio Finochietto
RECRUITING
Caba
CEMAIC (Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
RECRUITING
Córdoba
Clinica Viedma
RECRUITING
Viedma
Australia
Gallipoli Medical Research Foundation (Greenslopes Private Hospital)
COMPLETED
Greenslopes
Austin Hospital
RECRUITING
Heidelberg
Linear Clinical Research
RECRUITING
Nedlands
One Clinical Research - Nedlands
RECRUITING
Nedlands
Peter MacCallum Cancer Centre
RECRUITING
North Melbourne
Calvary Mater Newcastle Hospital
RECRUITING
Waratah
University of Sydney - Melanoma Institute Australia (MIA) - The Poche Centre
RECRUITING
Wollstonecraft
The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)
RECRUITING
Woolloongabba
Austria
LKH - Universitaetsklinikum Graz
RECRUITING
Graz
Universitätsklinikum St. Pölten
RECRUITING
Pölten
Paracelsus Medizinischen Privatuniversitaet - SALK - Universitaetsklinik fuer Dermatologie - EB-Haus Austria
RECRUITING
Salzburg
Belgium
Universite Libre de Bruxelles (ULB)-Institut Jules Bordet
RECRUITING
Anderlecht
AZ Sint-Jan Brugge-Oostende AV-Campus Sint-Jan
RECRUITING
Bruges
Cliniques Universitaires Saint-Luc - Institut Roi Albert II
RECRUITING
Brussels
Universitair Ziekenhuis Brussel
RECRUITING
Brussels
UZ Leuven
RECRUITING
Leuven
Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
RECRUITING
Barretos
Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia
RECRUITING
Brasília
Centro de Pesquisas Oncologicas (CEPON)
RECRUITING
Florianópolis
Oncocentro Sao Carlos Hospital
RECRUITING
Fortaleza
Centro de Pesquisa Clinica em Oncologia - Oncosite
RECRUITING
Ijuí
A.C.Camargo Cancer Center - Centro Internacional de Pesquisa (CIPE)
RECRUITING
Liberdade
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Ltda
RECRUITING
Porto Alegre
Hospital de Clinicas de Porto Alegre (HCPA)
RECRUITING
Porto Alegre
Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Hospital Sao Lucas - Centro de Pesquisa Clinica (CPC)
RECRUITING
Porto Alegre
Instituto Américas - Instituto de Educação Pesquisa e Gestão em Saúde Oncosite
RECRUITING
Rio De Janeiro
National Cancer Institute
RECRUITING
Rio De Janeiro
Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP) - Hospital de Base (HB) - Centro Integrado de Pesquisa (CIP)
RECRUITING
São Paulo
Hospital 9 de Julho
RECRUITING
São Paulo
Instituto do Cancer do Estado de Sao Paulo (ICESP)
RECRUITING
São Paulo
Bulgaria
Uni Hospital
RECRUITING
Panagyurishte
Complex Oncology Center - Plovdiv Ltd.
RECRUITING
Plovdiv
Regina Life Clinic
RECRUITING
Sofia
University Hospital Tsaritsa Yoanna (ISUL) (Queen Giovanna University Hospital)
RECRUITING
Sofia
Canada
Cross Cancer Institute
RECRUITING
Edmonton
Princess Margaret Cancer Centre
RECRUITING
Toronto
Denmark
Kobenhavns Universitet - Herlev Hospital (Amtssygehuset i Herlev)
RECRUITING
Herlev
France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Seine-Saint-Denis - Hopital Avicenne
RECRUITING
Bobigny
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Ambroise-Pare
RECRUITING
Boulogne-billancourt
UNICANCER-Centre Francois Baclesse (CFB)
RECRUITING
Caen
CHU de Dijon Bourgogne - Hôpital François Mitterrand
RECRUITING
Dijon
Centre Hospitalier Universitaire de Lille (CHU Lille)-Hopital Claude Huriez
RECRUITING
Lille
Hôpital de la Timone
RECRUITING
Marseille
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
RECRUITING
Nantes
Hospital Saint Louis
RECRUITING
Paris
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
RECRUITING
Pierre-bénite
Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Hopital Charles-Nicolle
RECRUITING
Rouen
Oncopole Claudius Regaud- Institut Universitaire du Cancer de Toulouse
RECRUITING
Toulouse
Hopital Robert Debre
RECRUITING
Valence
Institut Gustave Roussy (IGR) Service de Dermatolgie
RECRUITING
Villejuif
Germany
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Dermatologie Venerologie und Allergologie - Hauttumorcentrum Charite (HTCC)
RECRUITING
Berlin
Universitätsklinikum Carl Gustav Carus
RECRUITING
Dresden
Helios Klinikum Erfurt - Klinik fuer Hautkrankheiten und Allergologie
RECRUITING
Erfurt
Universitaetsklinikum Essen
RECRUITING
Essen
Johann Wolfgang Goethe-Universitaet Frankfurt am Main - Klinik fuer Dermatologie, Venerologie und Allergologie
RECRUITING
Frankfurt
Justus-Liebig-Universitaet Giessen - Klinik fuer Dermatologie und Andrologie
RECRUITING
Giessen
Elbe Kliniken Stade - Hautkrebszentrum Buxtehude
RECRUITING
Hamburg
University of Hamburg
RECRUITING
Hamburg
Universitaetsklinikum Heidelberg (UKHD) - Hautklinik
RECRUITING
Heidelberg
Universitaetsklinikum Leipzig - Klinik fuer Dermatologie, Venerologie und Allergologie
RECRUITING
Leipzig
Johannes Wesling Klinikum Minden
RECRUITING
Minden
LMU Klinikum - Klinik und Poliklinik fur Dermatologie und Allergologie
RECRUITING
Munich
Universitaetsklinikum Tuebingen (UKT) - Zentrum fuer Dermatoonkologie - Hautklinik
RECRUITING
Tübingen
Universitaetsklinikum Wuerzburg - Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie
RECRUITING
Würzburg
Hungary
Semmelweis Egyetem Általános Orvostudományi Kar
RECRUITING
Budapest
Pecsi Tudomanyegyetem (PTE) (University of Pecs)
RECRUITING
Pécs
Szegedi Tudomanyegyetem (University of Szeged)
RECRUITING
Szeged
Italy
Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari
RECRUITING
Bari
Humanitas Gavazzeni (Cliniche Gavazzeni S.p.A)
RECRUITING
Bergamo
IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori Dino Amadori Srl (IRST)
RECRUITING
Meldola
Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano
RECRUITING
Milan
Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)
RECRUITING
Milan
Istituto Nazionale Tumori (INT) Fondazione G. Pascale di Napoli
RECRUITING
Napoli
Istituto Oncologico Veneto (IOV) IRCCS
RECRUITING
Padua
Istituto Oncologico Veneto (IOV) IRCCS
RECRUITING
Padua
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
RECRUITING
Perugia
Azienda Sanitaria Locale di Biella (ASL BI) - Ospedale degli Infermi
RECRUITING
Ponderano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
National Cancer Institute Regina Elena
RECRUITING
Roma
Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte - Clinica Immunoterapia Oncologica
RECRUITING
Siena
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
RECRUITING
Torino
Norway
Haukeland University Hospital
RECRUITING
Bergen
Oslo University Hospital
RECRUITING
Oslo
Poland
Centrum Onkologii im. Prof. Franciszka Łukaszczyka
RECRUITING
Bydgoszcz
Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Centrum Medyczne Pratia Poznań - Skorzewo
COMPLETED
Skorzewo
Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków
RECRUITING
Warsaw
Romania
L'Institute Oncologique Prof. Dr. Ion Chiricuta (IOCN) (The Oncology Institute Prof. Dr. Ion. Chiricuta)
RECRUITING
Cluj-napoca
Sf Nectarie Oncology Center
RECRUITING
Craiova
Victoria Hospital (Centrul de oncologie Euroclinic SRL) (Centrul De Oncologie Medicala) (Euroclinic Onchology Center)
RECRUITING
Iași
Spain
Complejo Hospitalario Universitario A Coruna (CHUAC)
RECRUITING
A Coruña
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Duran i Reynals
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Dexeus
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Universidad de Murcia - Hospital Universitario Virgen de la Arrixaca (HUVA)
RECRUITING
El Palmar
Hospital Universitario Virgen de las Nieves (HUVN)
RECRUITING
Granada
Centro Integral Oncologico Clara Campal (CIOCC)
RECRUITING
Madrid
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Universidad Complutense de Madrid (UCM)-Hospital Universitario 12 de Octubre (H12O)
RECRUITING
Madrid
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid
RECRUITING
Madrid
Hospital Regional Universitario de Malaga
RECRUITING
Málaga
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
RECRUITING
Pamplona
Universidad de Cantabria (UC) - Hospital Universitario Marques de Valdecilla (HUMV)
RECRUITING
Santander
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Instituto de Investigacion Sanitaria (INCLIVA) (Institute of Health Research Hospital Clinic of Valencia)
RECRUITING
Valencia
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
RECRUITING
Valencia
Servicio Aragones de Salud - Hospital Universitario Miguel Servet (HUMS)
RECRUITING
Zaragoza
Sweden
Sahlgrenska Akademin - Institutionen for Kliniska Vetenskaper (Institute of Clinical Sciences)
RECRUITING
Gothenburg
Lanssjukhuset Ryhov - Onkologiska Kliniken
RECRUITING
Jönköping
Skanes Universitetssjukhus - Lund - Onkologiska Klinik
RECRUITING
Lund
Karolinska Universitetssjukhuset
RECRUITING
Stockholm
Uppsala Universitet - Akademiska Sjukhuset (Uppsala University Hospital)
RECRUITING
Uppsala
Switzerland
UniversitaetsSpital Zuerich - Dermatologische Klinik
RECRUITING
Zurich
Turkey
Kanser Enstitusu (Hacettepe University Cancer Institute)
RECRUITING
Altındağ
T.C. Saglik Bakanligi - SBU Gulhane Egitim ve Arastirma Hastanesi
RECRUITING
Ankara
Medical Park Hastaneler Grubu - I.A.U. VM Medical Park Florya
RECRUITING
Antalya
Memorial Saglik Grubu - Memorial Bahcelievler Hastanesi
RECRUITING
Bahçelievler
Ege Universitesi Tip Fakultesi (Ege University Faculty of Medicine)
RECRUITING
Bornova
Ankara Bilkent City Hospital, Oncology Department
RECRUITING
Çankaya
Memorial Saglik Grubu - Memorial Ankara Hastanesi
RECRUITING
Çankaya
Izmir Ekonomi Universitesi Medikal Point Hastanesi
RECRUITING
Cordaleo
Inonu Universitesi - Turgut Ozal Tip Merkezi
RECRUITING
Malatya
Ondokuz Mayis Universitesi (OMU) - Tip Facultesi
RECRUITING
Samsun
Medical Park Gaziantep Hastanesi
RECRUITING
Şehitkamil
Medical Park Seyhan Hastanesi
RECRUITING
Seyhan
T.C. Saglik Bakanligi - Ankara Etlik sehir Hastanesi
RECRUITING
Yenimahalle
United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH) - Oncology Centre
RECRUITING
Cambridge
Beatson West of Scotland Cancer Centre
RECRUITING
Glasgow
The Clatterbridge Cancer Centre NHS Foundation Trust
RECRUITING
Liverpool
Sarah Cannon Research Institute (SCRI) - London (SCRI-UK)
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Royal Marsden Hospital - Sutton
RECRUITING
Surrey Quays
Contact Information
Primary
Immunocore Medical Information
medical.information@immunocore.com
844-466-8661
Backup
Immunocore Medical Information EU
medinfo.eu@immunocore.com
+00 800-744-51111
Time Frame
Start Date: 2024-06-05
Estimated Completion Date: 2027-10-16
Participants
Target number of participants: 680
Treatments
Experimental: 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.
Experimental: 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.
Active_comparator: Arm C: Nivolumab OR Nivolumab + Relatlimab
Participants receive nivolumab 480 mg monotherapy, or nivolumab 480 mg + relatlimab 160 mg, Q4W.
Related Therapeutic Areas
Sponsors
Leads: Immunocore Ltd