Advanced MelanomaPhase 3PRISM-MEL-301NCT06112314
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
A Phase 3 study testing Brenetafusp, Nivolumab and Nivolumab + Relatlimab in people with Advanced Melanoma, run by Immunocore Ltd at 211 sites in 26 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- Brenetafusp, Nivolumab and Nivolumab + Relatlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 211 sitesin 26 countries
- Study dates
- 5 Jun 2024to 16 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
211 sites in 26 countries. Contact the study team or a site near you to ask about taking part.
211 sites in 26 countries
United States37 sites, 33 recruiting
- Recruiting
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
Kayla Vondran, 720-848-9381, KAYLA.VONDRAN@CUANSCHUTZ.EDU
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kamaneh Montazeri, MD, 617-724-4000, kmontazeri@mgh.harvard.edu
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Linnea Drew, 617-632-6704, linneam_drew@dfci.harvard.edu
- Recruiting
UVA Health-UVA Emily Couric Clinical Cancer Center
Charlottesville, Virginia, 22903
uvacancertrials@hscmail.mcc.virginia.edu
- Recruiting
Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI
Chicago, Illinois, 60611
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Sierra Cimafranca, 614-685-1911, Sierra.Cimafranca@osumc.edu
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75235-9179
Desiree Pierre, 214-645-9830, desiree.pierre@utsouthwestern.edu
- Recruiting
The Melanoma & Skin Cancer Institute
Denver, Colorado, 80222
Brandon Keith, 303-777-2663, bkeith@westernstatesncorp.org
- Recruiting
Henry Ford Cancer Center - Michigan
Detroit, Michigan, 04820
Bethany Adams, 248-224-7345, badams19@hfhs.org
- Recruiting
St. Elizabeth Healthcare - Edgewood
Edgewood, Kentucky, 41017
Elizabeth Beatty, CRC, 859-301-4243, Elizabeth.Beatty@stelizabeth.com
- Completed
UConn Health-Farmington (University of Connecticut Health Center (UCHC))
Farmington, Connecticut, 06030-2205
- Recruiting
Prisma Health Cancer Institute
Greenville, South Carolina, 29605
Lisa Johnson, Lisa.johnson@prismahealth.org
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Oncology Clinical Research Referral Office, 551-996-1777, OncologyResearchReferral@hmhn.org
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Heidi Turner, 904-953-5323, Turner.Heidi@mayo.edu
- Recruiting
The University of Tennessee - Knoxville (UTK)
Knoxville, Tennessee, 37920
Megan McKenzie, RN, 865-305-6284
- Recruiting
University of California - San Diego
La Jolla, California, 92093-0698
Katie O'Neil, 858-822-6575, croneil@health.ucsd.edu
- Recruiting
Northwell Health Cancer Institute
Lake Success, New York, 11042
Sarilee Liz, sliz@northwell.edu
- Recruiting
The Angeles Clinic and Research Institute- West Los Angeles
Los Angeles, California, 90025
Saba Mukarram, 310-231-2181, SMukarram@theangelesclinic.org
- Recruiting
ESC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Sandy Tran, 323-865-3935, Sandy.tran@med.usc.edu
- Recruiting
UCLA Hematology/Oncology
Los Angeles, California, 90095
Jessica Crocker, 310-794-3266, JCrocker@mednet.ucla.edu
- Recruiting
University of Miami Health System-Sylvester Comprehensive Cancer Center-Miami
Miami, Florida, 33136
CRSCutaneous@miami.edu
- Recruiting
Allina Health Cancer Institute - Minneapolis
Minneapolis, Minnesota, 55407
Jonathan Alexander, 612-863-8625, jonathan.alexander@allina.com
- Recruiting
Sarah Cannon Research Institute: USA/TN
Nashville, Tennessee, 37203
- Recruiting
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Mindy Jordan, 888-555-2835, mejordan@tnonc.com
- Completed
Columbia University Medical Center
New York, New York, 10032
- Completed
Stanford Cancer Institute - Stanford Cancer Center Palo Alto
Palo Alto, California, 94304
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Madeleine Martinelli, 267-414-8820, Madeleine.martinelli@jefferson.edu
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Kelly Schroder, 412-623-3544, schroderka@upmc.edu
- Recruiting
Virginia Commonwealth University (VCU) - Massey Cancer Center
Richmond, Virginia, 23298-0070
Faith McFadden, 804-628-0616, masseyskinca@vcu.edu
- Recruiting
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Shantae George, 801-213-8486, shantae.george@hci.utah.edu
- Recruiting
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica, California, 90404
Maribel Ramirez, 310-582-7457, maribel.ramirez1@providence.org
- Recruiting
Swedish Medical Center - Swedish Cancer Institute (SCI) - First Hill Campus
Seattle, Washington, 98104
CancerResearch, 206-215-3125, cancerresearch@swedish.org
- Recruiting
Spartanburg Regional Healthcare System - Spartanburg Medical Center (SMC)
Spartanburg, South Carolina, 29303
Kristen Ford, RN MSN, 864-530-6554, kford@gibbscc.org
- Completed
Washington University School of Medicine
St Louis, Missouri, 63110
- Recruiting
University of Arizona
Tucson, Arizona, 85720
Terri Katz, 520-621-2029, tkatz@arizona.edu
- Recruiting
Georgetown University
Washington D.C., District of Columbia, 20007
- Recruiting
The University of Kansas Cancer Center (KUCC) - Westwood
Westwood, Kansas, 66205
CT Nurse Navigator, 913-945-7552, CTNurseNav@kumc.edu
Spain26 sites, 26 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruna (CHUAC)
A Coruña, 15006
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Universitario Dexeus
Barcelona, 08035
- Recruiting
Hospital Duran i Reynals
Barcelona, 08908
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 8036
Nadina Fradera, 0034687727943, fradera@recerca.clinic.cat
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
Manuel Sánchez Ostos
957 002 343, manuel.sanchez.oncologia@gmail.com
- Recruiting
Universidad de Murcia - Hospital Universitario Virgen de la Arrixaca (HUVA)
El Palmar, Murcia, 30120
Paula Ruiz Carreño, 0034968369387, dm.oncoarrixaca2@gmail.com
- Recruiting
Hospital Universitario Virgen de las Nieves (HUVN)
Granada, 18014
Isabel Rodriguez, 0034 958 145 591 ext. 179591, i_rodriguez_gonzalez@hotmail.es
- Recruiting
Hospital Universitario Insular De Gran Canaria
Las Palmas de Gran Canaria, 35016
Fatima Guillen Suarez, 34 92 841 738, uecchuimi.scs@gobiernodecanarias.org
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28009
Isabel Cañete, 0034 914268161, icg.hgugm@gmail.com
- Recruiting
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid
Madrid, 28027
Sara Diaz Sánchez, 0034 913 531 920 ext. 7604, sdiazsanch@unav.es
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Recruiting
Universidad Complutense de Madrid (UCM)-Hospital Universitario 12 de Octubre (H12O)
Madrid, 28041
Guillermo de Velasco, 913908003, gdvelasco.gdv@gmail.com
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Yolanda Álvarez Pérez, 917277516, yolandalapaz@gmail.com
- Recruiting
Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, 28050
- Recruiting
Hospital Regional Universitario de Malaga
Málaga, 29016
Irene Rojas, 0034 608093004, ensayosch@yahoo.es
- Recruiting
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
Pamplona, 31008
Eduardo De la Guardia, 0034 948 296 666 + 2736, edelaguardia@unav.es
- Recruiting
Hospital Universitari Sant Joan de Reus
Reus, 43204
Francisca Martínez Madueño, (+34) 664 300 708, francisca.martinez@salutsantjoan.cat
- Recruiting
Onkologikoa - Kutxaren Institutu Onkologikoa (Instituto Oncologico De Guipuzcoa)
San Sebastián, 20014
Ainhoa Arocena, 94 332 8315
Lidia Nieto, 94 332 8315
- Recruiting
Universidad de Cantabria (UC) - Hospital Universitario Marques de Valdecilla (HUMV)
Santander, Cantabria, 39008
Marta Sotelo, 942 20 33 51 ext. 73351, marta.sotelo@scsalud.es
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Mónica Suengas, 697958425, moni.suengas@gmail.com
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
- Recruiting
Instituto de Investigacion Sanitaria (INCLIVA) (Institute of Health Research Hospital Clinic of Valencia)
Valencia, 46010
Inés González Barrallo, MD, +34 961 973 517, igbarrallo@gmail.com
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46014
- Recruiting
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, 46026
Maite Giralt, 34 638 037 641, sconcologia@iislafe.es
34 96 124 41 88
- Recruiting
Servicio Aragones de Salud - Hospital Universitario Miguel Servet (HUMS)
Zaragoza, 50009
Germany20 sites, 20 recruiting
- Recruiting
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Dermatologie Venerologie und Allergologie - Hauttumorcentrum Charite (HTCC)
Berlin, 10115
Max Schlaak, MD, 4930450518448, studien-hauttumorcentrum@charite.de
Max Schlaak, MD, 4930450518309, studien-hauttumorcentrum@charite.de
- Recruiting
Klinikum Bremen-Ost gGmbH
Bremen, 28205
Dr. Miriam Schiff, 04 21-497 70452, miriam.schiff@gesundheitnord.de
- Recruiting
Klinikum Dortmund gGmbH - Klinikzentrum Mitte - Hautklinik
Dortmund, 44137
- Recruiting
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
Daniela Walther, 0049 351 458 19782
- Recruiting
Helios Klinikum Erfurt - Klinik fuer Hautkrankheiten und Allergologie
Erfurt, 99089
Prof. Dr. med. Rudolf A Herbst, MD, 0361 781-4301, rudolf.herbst@helios-gesundheit.de
- Recruiting
Universitaetsklinikum Erlangen
Erlangen, 91054
Onkologische Studienzentrale der Hautklinik, 09 131-854 5861, onkstudienzentrale.de@uk-erlangen.de
- Recruiting
Universitaetsklinikum Essen
Essen, 45122
Jessica Bauriedl, 02017232325, Jessica.bauriedl@uk-essen.de
- Recruiting
Johann Wolfgang Goethe-Universitaet Frankfurt am Main - Klinik fuer Dermatologie, Venerologie und Allergologie
Frankfurt, 60590
Dr. Berenice Lang, MD, 4969630183115, berenice.lang@unimedizin-ffm.de
- Recruiting
Justus-Liebig-Universitaet Giessen - Klinik fuer Dermatologie und Andrologie
Giessen, D-35392
(+)49641-985-43200
- Recruiting
University of Hamburg
Hamburg, 20246
Prof. Dr. Gebhardt, 4940741057626, Studien-htz@uke.de
- Recruiting
Elbe Kliniken Stade - Hautkrebszentrum Buxtehude
Hamburg, 22045
Uta Haisch, 4941617036212, Uta.Haisch@elbekliniken.de
- Recruiting
Universitaetsklinikum Heidelberg (UKHD) - Hautklinik
Heidelberg, 69120
Prof. Jessica Hassel, MD, 496221568562, NCT.DermaOnko@med.uni-heidelberg.de
- Recruiting
University Hospital Schleswig-Holstein
Kiel, DE-24105
- Recruiting
Universitaetsklinikum Leipzig - Klinik fuer Dermatologie, Venerologie und Allergologie
Leipzig, 4103
Jan Christoph Simon, MD, 00493419718600, Jan.simon@medizin.uni-leipzig.de
- Recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, D-55131
Jennifer Nostadt, 49 6131 / 17-8412, birgit.huebscher@unimedizin-mainz.de
- Recruiting
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
Marburg, 35043
- Recruiting
Johannes Wesling Klinikum Minden
Minden, 32429
Yenny Angela, 57179054523, yenny.angela@muehlenkreiskliniken.de
- Recruiting
LMU Klinikum - Klinik und Poliklinik fur Dermatologie und Allergologie
Munich, 81377
Prof. Lucie Heinzerling, MD, +4989440056326, DER.onko.studien@med.uni-muenchen.de
- Recruiting
Universitaetsklinikum Tuebingen (UKT) - Zentrum fuer Dermatoonkologie - Hautklinik
Tübingen, 72076
Teresa Amaral, MD, PhD, 004970712985748, Teresa.amaral@med.uni-tuebingen.de
- Recruiting
Universitaetsklinikum Wuerzburg - Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie
Würzburg, 97080
Anja Gesierich, MD, 4993120126762, Gesierich_A@ukw.de
Italy15 sites, 15 recruiting
- Recruiting
Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari
Bari, 70124
- Recruiting
Humanitas Gavazzeni (Cliniche Gavazzeni S.p.A)
Bergamo, 24125
- Recruiting
IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST)
Meldola, 47014
- Recruiting
Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)
Milan, 20141
Raffaella Ghisini, raffaella.ghisini@ieo.it
- Recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano
Milan, 20133
- Recruiting
Azienda Ospedaliero-Universitaria di Modena (AOU Modena) - Policlinico di Modena - Day Hospital Oncologico
Modena, 41124
- Recruiting
Istituto Nazionale Tumori (INT) "Fondazione G. Pascale" di Napoli
Naples, 80131
- Recruiting
Istituto Oncologico Veneto (IOV) IRCCS
Padova, 35128
- Recruiting
Istituto Oncologico Veneto (IOV) IRCCS
Padova, I-35128
- Recruiting
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Perugia, 06129
- Recruiting
Azienda Sanitaria Locale di Biella (ASL BI) - Ospedale degli Infermi
Ponderano, 13875
- Recruiting
National Cancer Institute Regina Elena
Roma, 00128
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 0168
- Recruiting
" Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte - Clinica Immunoterapia Oncologica"
Siena, 53100
- Recruiting
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, 10126
Turkey (Türkiye)15 sites, 15 recruiting
- Recruiting
Kanser Enstitusu (Hacettepe University Cancer Institute)
Altındağ, 6230
- Recruiting
T.C. Saglik Bakanligi - SBU Gulhane Egitim ve Arastirma Hastanesi
Ankara, 6100
Dr Nuri Karadurmus, +90 536 640 10 20, drnkaradurmus@yahoo.com
- Recruiting
Medical Park Hastaneler Grubu - I.A.U. VM Medical Park Florya
Antalya, Campus, 07070
Ali Murat Tatli, alimurattat@hotmail.com
- Recruiting
Memorial Saglik Grubu - Memorial Bahcelievler Hastanesi
Bahçelievler, Istanbul, 34180
Hakan Harputluoglu
- Recruiting
Ege Universitesi Tip Fakultesi (Ege University Faculty of Medicine)
Bornova, İzmir, 35100
Fulden Saraç, 53 09 672 608, fulden.sarac@atlascro.com.tr
- Recruiting
Memorial Saglik Grubu - Memorial Ankara Hastanesi
Çankaya, Ankara, 06520
Umut Demirci, 0506 752 12 75, drumutdemirci@gmail.com
- Recruiting
Ankara Bilkent City Hospital, Oncology Department
Çankaya, 6800
- Recruiting
Izmir Ekonomi Universitesi Medikal Point Hastanesi
Cordaleo, İzmir, 35575
Cagatay Arslan, MD, 505 264 2353, arslancagatay@yahoo.com
- Recruiting
Memorial Antalya Hastanesi
Kepez, Antalya, 7025
Ali Murat Tatli, MD, 00 90 532 7115 637, alimurattat@hotmail.com
- Recruiting
Inonu Universitesi - Turgut Ozal Tip Merkezi
Malatya, 44280
Mustafa Dikilitas, 0533 572 01 75, dikilitasmd@yahoo.com
- Recruiting
Ondokuz Mayis Universitesi (OMU) - Tip Facultesi
Samsun, 55270
Bahiddin Yilmaz, 0532 599 28 25, yilmazbahiddin80@gmail.com
- Recruiting
Medical Park Gaziantep Hastanesi
Şehitkamil, Gaziantep, 27584
Alper Sevinc, MD, 0555 241 46 87, alpersevinc27@hotmail.com
- Recruiting
Medical Park Seyhan Hastanesi
Seyhan, 1140
Ahmet Sezer, +90 533 361 69 39, drasezer@hotmail.com.tr
- Recruiting
T.C. Saglik Bakanligi - Ankara Etlik sehir Hastanesi
Yenimahalle, 06170
Nilay Ertunc Cayan, +90 536 640 10 20, nilay.ertunc@medismart.com.tr
- Recruiting
T.C. Saglik Bakanligi - Adana Numune Egitim ve Arastirma Hastanesi (Adana Numune Education and Research Hospital)
Yüreğir, Adana, 1370
Sevilay Demircioglu, 90 554 861-2028, sevilay.demircioglu@ebmresearch.com
Brazil14 sites, 14 recruiting
- Recruiting
Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
Barretos, 14784
- Recruiting
Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia
Brasília, DF CEP 70200-730
Cristiany de Jesus da Siva de Lima, 55 61 2141 4856, cristiany.jslima@hsl.org.br
- Recruiting
Centro de Pesquisas Oncologicas (CEPON)
Florianópolis, 88034-000
Camila Donadel, +55 48 3331-1553, camila.donadel@cepon.org.br
- Recruiting
Oncocentro Sao Carlos Hospital
Fortaleza, 60135-237
Diogenes Leite, 55 85 30348677, diogenes.leite@idor.org
- Recruiting
Centro de Pesquisa Clinica em Oncologia - Oncosite
Ijuí, Rio Grande do Sul, 98700-000
Fábio André Franke, 55 55 3195-0504, oncositeijui@gmail.com
- Recruiting
A.C.Camargo Cancer Center - Centro Internacional de Pesquisa (CIPE)
Liberdade, 01509-010
Guilherme Cavalcante Pessoa, 2189-5000 (5138), guilherme.cavalcante@accamargo.org.br
- Recruiting
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Ltda
Porto Alegre, Rio Grande do Sul, 90110-270
Alan Azambuja, MD, +55 51-33072943, cgi.pesquisa@gmail.com
- Recruiting
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, 90035-903
Andrea Baldasso Zanon, 55 51 3359-8619, abzanon.upco@gmail.com
Sergio Jobim de Azevedo, 55 51 3359-8619, sazevedo@hcpa.edu.br
- Recruiting
Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Hospital Sao Lucas - Centro de Pesquisa Clinica (CPC)
Porto Alegre, 90610-000
Virginia Webber, 51 3320-3039, virginia.webber@cpors.com
- Recruiting
National Cancer Institute
Rio de Janeiro, 20220-410
Andreia Cristina de Melo, MD, +55 (21) 99173-9618, andreia.melo@inca.gov.br
- Recruiting
Instituto Américas - Instituto de Educação Pesquisa e Gestão em Saúde Oncosite
Rio de Janeiro, 22775-001
Raphaela Lima, MD, +5521 96845-7879, centrodepesquisa@institutoamericas.org
- Recruiting
Instituto do Cancer do Estado de Sao Paulo (ICESP)
São Paulo, 01246-000
- Recruiting
Hospital 9 de Julho
São Paulo, 01308-070
Rafael Shimerling, 11 9948-3000, rafael.schmerling.ext@dasa.com.br
- Recruiting
Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP) - Hospital de Base (HB) - Centro Integrado de Pesquisa (CIP)
São Paulo, 15090-000
Thamyres Arroyo, +55 17 32015054, thamyres.cruz@centrodepesquisacip.com.br
France13 sites, 12 recruiting
- Completed
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Seine-Saint-Denis - Hopital Avicenne
Bobigny, 93000
- Recruiting
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Ambroise-Pare
Boulogne-Billancourt, 92104
- Recruiting
UNICANCER-Centre Francois Baclesse (CFB)
Caen, 14000
Dr Stefan Andreea, MD, 33234455050, a.stefan@baclesse.unicancer.fr
- Recruiting
CHU de Dijon Bourgogne - Hôpital François Mitterrand
Dijon
Meryem DEBBABI, 33380293842, meryem.debbabi@chu-dijon.fr
Elisabeth CORNOT, 33380669466, elisabeth.cornot@chu-dijon.fr
- Recruiting
Centre Hospitalier Universitaire de Lille (CHU Lille)-Hopital Claude Huriez
Lille, 59037
Pr Laurent Mortier, 0033320444193, laurent.mortier@chu-lille.fr
- Recruiting
Hôpital de la Timone
Marseille, Cedex, 13385
- Recruiting
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Nantes
- Recruiting
Hospital Saint Louis
Paris, 75010
- Recruiting
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69310
- Recruiting
Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Hopital Charles-Nicolle
Rouen, 76031
Orlane DEBOVES, 0232886699, orlane.deboves@chu-rouen.fr
Raphaëlle DAVESNE, 0232886699, raphaelle.davesne@chu-rouen.fr
- Recruiting
Oncopole Claudius Regaud- Institut Universitaire du Cancer de Toulouse
Toulouse, Cedex, 31059
- Recruiting
Hopital Robert Debre
Valence, 26000
- Recruiting
Institut Gustave Roussy (IGR) Service de Dermatolgie
Villejuif, 94800
Australia8 sites, 7 recruiting
- Completed
Gallipoli Medical Research Foundation (Greenslopes Private Hospital)
Greenslopes, Queensland, 4120
- Recruiting
Austin Hospital
Heidelberg, 3084
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 06009
Anke Hoskins, 61-8-6383 3189, Anke.Hoskins@health.wa.gov.au
- Recruiting
One Clinical Research - Nedlands
Nedlands, Western Australia, 06009
Prof. Adnan Khattak, +61 8 6279 9466, info@oneclinicalresearch.com.au
- Recruiting
Peter MacCallum Cancer Centre
North Melbourne, 3051
Dr Lavinia Spain, 61385595000, Enquiries.GMR@gallipoliresearch.org.au
- Recruiting
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 02298
MOR Clinical Trials, (02) 40143280, Kim.Adler@calvarymater.org.au
- Recruiting
University of Sydney - Melanoma Institute Australia (MIA) - The Poche Centre
Wollstonecraft
- Recruiting
The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)
Woolloongabba
United Kingdom8 sites, 7 recruiting
- Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH
- Recruiting
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH) - Oncology Centre
Cambridge, CB20QQ
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Dr Pavlina Spiliopoulou, MD, 0141 301 7043, pavlina.spiliopoulou2@nhs.scot
- Recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, L78YA
Pembe Yeslidag, 01515565435, pembe.yesildag@nhs.net
- Completed
Sarah Cannon Research Institute (SCRI) - London (SCRI-UK)
London, W1G 6AD
- Recruiting
The Christie NHS Foundation Trust
Manchester, M204BX
- Recruiting
University of Oxford
Oxford, Ox37LE
Dr Miranda Payne, MD, 01 865 74 1841
- Recruiting
Royal Marsden Hospital - Sutton
Surrey Quays, SM2 5PT
Argentina6 sites, 6 recruiting
- Recruiting
Hospital Italiano de Buenos Aires (HIBA)
Buenos Aires, C1199ABD
- Recruiting
Sanatorio Finochietto
Caba, Buenos Aires, 1213
Dr. Gabriela Cinat, 541158216233, gabriela_cinat@yahoo.com.ar
- Recruiting
Clínica Adventista Belgrano - Sector Investigación
Caba, Buenos Aires, C1430EGF
Aldo A. Perfetti, 5491132682903, aaperfetti@yahoo.com.ar
- Recruiting
Instituto Alexander Fleming
CABA, CP1426ANZ
- Recruiting
CEMAIC (Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, X5008HHW
Dra. Laura Nardone, 54 9 351 678-3938, lauranardone@cemaicsas.com.ar
- Recruiting
Clinica Viedma
Viedma, R8500ACE
Ruben Kowalyszyn, 542920601693, kowar@rnonline.com.ar
Belgium5 sites, 5 recruiting
- Recruiting
Universite Libre de Bruxelles (ULB)-Institut Jules Bordet
Anderlecht, 01070
Dr. Langouo, 00 32 2 541 33 77, m.langouofontsa@hubruxelles.be
- Recruiting
AZ Sint-Jan Brugge-Oostende AV-Campus Sint-Jan
Bruges, 8000
Angelique Slock, 3250452849, angelique.slock@azsintjan.be
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, 1090
Loes De Koster, 02 476 33 94, loes.dekoster@uzbrussel.be
- Recruiting
Cliniques Universitaires Saint-Luc - Institut Roi Albert II
Brussels, 1200
Fontaine Florence, 32 276 48 509, florence.fontaine@saintluc.uclouvain.be
- Recruiting
UZ Leuven
Leuven, 03000
Trial AMO UZ Leuven, trialamo@uzleuven.be
Hungary5 sites, 5 recruiting
- Recruiting
Semmelweis Egyetem Általános Orvostudományi Kar
Budapest, 1085
Péter Holló, MD, +36-20-8258870, hollo.peter@med.semmelweis-univ.hu
- Recruiting
Orszagos Onkologiai Intezet (National Institute of Oncology)
Budapest, 1122
Dr. Tímea Balatoni, MD, 36 30 990 9862, balatoni.timea@oncol.hu
- Recruiting
Debreceni Egyetem-Klinikai Kozpont (DEKK)
Debrecen
Dr. Gabriella Emri, MD, 36 30 437 4672, gemri@med.unideb.hu
- Recruiting
Pecsi Tudomanyegyetem (PTE) (University of Pecs)
Pécs, 7624
Zsuzsanna Lengyel, MD, 36303599887, lengyel.zsuzsanna@pte.hu
- Recruiting
Szegedi Tudomanyegyetem (University of Szeged)
Szeged, 6720
Eszter Baltás, MD, +36-303468499, ebaltas@gmail.com
Sweden5 sites, 5 recruiting
- Recruiting
Sahlgrenska Akademin - Institutionen for Kliniska Vetenskaper (Institute of Clinical Sciences)
Gothenburg, SE41345
- Recruiting
Lanssjukhuset Ryhov - Onkologiska Kliniken
Jönköping, 553 05
Bo Thelin, 46102425943, bo.thelin@rjl.se
- Recruiting
Skanes Universitetssjukhus - Lund - Onkologiska Klinik
Lund, 22185
- Recruiting
Karolinska Universitetssjukhuset
Stockholm, 171 76
Amanda Hallgren, +46 08-123-717-91, amanda.hallgren@regionstockholm.se
- Recruiting
Uppsala Universitet - Akademiska Sjukhuset (Uppsala University Hospital)
Uppsala, SE75185
Austria4 sites, 4 recruiting
- Recruiting
LKH - Universitaetsklinikum Graz
Graz, 8036
Alexandra Rodlauer-Kriegl, 43 31 638 580 169, alexandra.rodlauer-kriegl@medunigraz.at
- Recruiting
Universitätsklinikum St. Pölten
Pölten
- Recruiting
Paracelsus Medizinischen Privatuniversitaet - SALK - Universitaetsklinik fuer Dermatologie - EB-Haus Austria
Salzburg, 5020
- Recruiting
AKH - Medizinische Universität Wien
Vienna, 1090
Prof. Höller Christoph, 43 (0)1 40400 77310
Bulgaria4 sites, 4 recruiting
- Recruiting
Uni Hospital
Panagyurishte, 4500
Milena Kardaleva, 359888844526, kardaleva@gmail.com
- Recruiting
Complex Oncology Center - Plovdiv Ltd.
Plovdiv, 4000
- Recruiting
University Hospital Tsaritsa Yoanna (ISUL) (Queen Giovanna University Hospital)
Sofia, 1527
- Recruiting
Regina Life Clinic
Sofia
Poland4 sites, 2 recruiting
- Completed
Centrum Onkologii im. Prof. Franciszka Łukaszczyka
Bydgoszcz, 85796
- Recruiting
Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Izabela Gudewicz, izabelagudewicz@gumed.edu.pl
- Completed
Centrum Medyczne Pratia Poznań - Skorzewo
Skorzewo, 60185
- Recruiting
Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków
Warsaw, 02-781
Beata Wielgocka, 225462603, beata.wielgocka@pib-nio.pl
Czechia3 sites, 2 recruiting
- Recruiting
Fakultni Nemocnice Hradec Kralove (FNHK) - Klinika Onkologie a Radioterapie
Hradec Králové, 500 05
Jindřich Kopecký, PhD, 42 0495834980, jindrich.kopecky@fnhk.cz
- Recruiting
Fakultni Nemocnice Olomouc (FNOL)
Olomouc, 77900
Bohuslav Melichar, (+420)588444295, Bohuslav.Melichar@fnol.cz
- Completed
Sanatorium Profesora Arenbergera
Prague, 110 00
Finland3 sites, 3 recruiting
- Recruiting
Helsingin Yliopistollinen Keskussairaala - Cancercentrum
Helsinki, 00290
Micaela Hernberg, MD, 00 35 850 4279 490, micaela.hernberg@hus.fi
- Recruiting
Pirkanmaan Sairaanhoitopiiri (Pirkanmaa Hospital District)-Tampereen Yliopistollinen Sairaala (Tampere University Hospital)
Tampere, 33520
Tanja Skyttä, MD, 35 84 447 28790, tanja.skyttä@pirha.fi
- Recruiting
Turun Yliopistollinen Keskussairaala (TYKS)
Turku, 20520
Saana-Maaria Virtanen, MD, 35 82 313 5090, saana.maaria.virtanen@varha.fi
Portugal3 sites, 3 recruiting
- Recruiting
Centro Hospitalar e Universitario de Coimbra EPE (CHUC)
Coimbra, 3004-561
- Recruiting
Instituto Portugues de Oncologio de Lisboa Francisco Gentil EPE (IPO Lisboa) (IPOLFG)
Lisbon, 1099-023
Dr. Patricia Pereira, 35 1 21 722 9892, pmsilva@ipolisboa.min-saude.pt
- Recruiting
Hospital Lusiadas Lisboa (HPP Hospital Dos Lusiadas)
Lisbon, 1649-035
Sofia Torres, MD, sofia.torres@chln.min-saude.pt
Romania3 sites, 3 recruiting
- Recruiting
L'Institute Oncologique Prof. Dr. Ion Chiricuta (IOCN) (The Oncology Institute Prof. Dr. Ion. Chiricuta)
Cluj-Napoca, 400015
Dana Iancu, 40 745 364 514, dana_iancu2004@yahoo.com
- Recruiting
Sf Nectarie Oncology Center
Craiova, 200542
Augustin Gheorghe, 40723557512, gusti.gheorghe@yahoo.com
- Recruiting
Victoria Hospital (Centrul de oncologie Euroclinic SRL) (Centrul De Oncologie Medicala) (Euroclinic Onchology Center)
Iași, 700106
Constantin Volovat, MD, 40 746 110 096, cvolovat@gmail.com
Canada2 sites, 2 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, T6G 1Z2
Dr. John Walker, MD, 780-577-8082
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1
Marcus Butler, MD, 416-946-4501 ext. 5485, marcus.butler@uhn.ca
Lithuania2 sites, 2 recruiting
- Recruiting
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, 50161
Rima Adomaitiene, 37 06 010 5626, rima.deltuvaite@gmail.com
- Recruiting
Vilnius University Hospital Santaros Clinics Affiliate National Cancer Center
Vilnius, LT-08406
Aiste Sukstiene, 37 05 274 6459, aiste.sukstiene@nvc.santa.lt
Mexico2 sites, 2 recruiting
- Recruiting
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44280
- Recruiting
Centro Oncologico Internacional(COI) - Ciudad de Mexico
Mexico City, 04701
Norway2 sites, 2 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 05009
Cornelia Schuster, MD, 4755972010, cornelia.schuster@helse-bergen.no
- Recruiting
Oslo University Hospital
Oslo, 0379
Anna Winge-Main, +47 452 59938, annwi@ous-hf.no
Denmark1 site, 1 recruiting
- Recruiting
Kobenhavns Universitet - Herlev Hospital (Amtssygehuset i Herlev)
Herlev, 2730
Inge Marie Svane, 004538362131, inge.marie.svane@regionh.dk
Switzerland1 site, 1 recruiting
- Recruiting
UniversitaetsSpital Zuerich - Dermatologische Klinik
Zurich, 8901
Prof. Dr. med Reinhard Dummer, MD, 41442552507, Reinhard.dummer@usz.ch
About this study
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
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.
- Conditions
- Advanced Melanoma
- Being tested
- Brenetafusp, Nivolumab, Nivolumab + Relatlimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrenetafuspDrug
Also called IMC-F106C
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.
NivolumabDrug
Also called OPDIVO
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
Nivolumab + RelatlimabDrug
Also called OPDUALAG
Concentrate for solution for infusion at a unit dose of 16 mg/mL.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Brenetafusp Low Dose + Nivolumab | Experimental | 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.
Closed to randomization after dose recommendation by the IDMC in November 2025. Receives: Drug: Brenetafusp; Drug: Nivolumab |
| Arm B: Brenetafusp High Dose + Nivolumab | Experimental | 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.
Selected as go-forward experimental arm after dose recommendation by the IDMC in November 2025 Receives: Drug: Brenetafusp; Drug: Nivolumab |
| Arm C: Nivolumab OR Nivolumab + Relatlimab | Active comparator | Participants receive nivolumab 480 mg monotherapy, or nivolumab 480 mg + relatlimab 160 mg, Q4W. Receives: Drug: Nivolumab; Drug: Nivolumab + Relatlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Measured: Up to ~45 months
Secondary outcomes (9)
Overall Survival (OS)
OS is the time from randomization to time of death from any cause.
Measured: Up to ~57 months
Overall Response Rate (ORR)
ORR as assessed by BICR according to RECIST 1.1.
Measured: Up to ~45 months
Number of Participants Experiencing ≥1 Adverse Event (AE)
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition that occur in the study.
Measured: Up to ~57 months
Number of Participants Experiencing ≥1 Serious Adverse Event (SAE)
An SAE is any untoward medical consequence that results in death; requires inpatient hospitalization or prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or any other important medical event in the opinion of the Investigator.
Measured: Up to ~57 months
Number of Participants Experiencing a Dose Interruption, Reduction, or Discontinuation
The number of participants with a dose interruption, reduction, or discontinuation due to AE will be reported.
Measured: Up to ~45 months
Maximum Plasma Concentration (Cmax) of IMC-F106C
The Cmax of IMC-F106C will be reported.
Measured: Day 1 of Weeks 1, 2, and 3: Predose and 0.5 and 4 hours postdose
Incidence of anti-IMC-F106C Antibodies
The incidence of anti-IMC-F106C antibodies, including neutralizing antibodies, will be reported.
Measured: Up to ~45 months
Association between PFS and Intra-Tumor Immune Cells
The potential association between the effect of IMC-F106C on efficacy and intra-tumor environment will be explored. Intra-tumor environment is estimated as the ratio of CD3+ to CD163+ cells and the correlation with PFS will be estimated by the hazard ratio (+/- 95% CI) from a Cox model. This analysis will be restricted to subjects randomized to receive IMC-F106C.
Measured: Up to ~45 months
Health-Related Quality of Life
The change from baseline over time and between treatments of health-related quality of life will be reported.
Measured: Up to ~45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start5 Jun 2024
- Primary completion16 Oct 2027 (estimated)
- Study completion16 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunocore Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112314
- Sponsor's protocol ID
- IMC-F106C-301
- Other IDs
- 2023-505306-42, 2023
- Acronym
- PRISM-MEL-301
- Status last verified
- Feb 2026
- First submitted
- 19 Oct 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06112314
- Acronym / sponsor ID
- PRISM-MEL-301 / IMC-F106C-301
- Conditions
- Advanced Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Immunocore LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 16 Oct 2027 (estimated)
- Study completion
- 16 Oct 2027 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Brenetafusp Low Dose + Nivolumab | Experimental | Drug: Brenetafusp, Drug: NivolumabParticipants 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. Closed to randomization after dose recommendation by the IDMC in November 2025. |
| Arm B: Brenetafusp High Dose + Nivolumab | Experimental | Drug: Brenetafusp, Drug: NivolumabParticipants 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. Selected as go-forward experimental arm after dose recommendation by the IDMC in November 2025 |
| Arm C: Nivolumab OR Nivolumab + Relatlimab | Active comparator | Drug: Nivolumab, Drug: Nivolumab + RelatlimabParticipants receive nivolumab 480 mg monotherapy, or nivolumab 480 mg + relatlimab 160 mg, Q4W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrenetafuspAlso: IMC-F106CSoluble 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. | Drug | Arm A: Brenetafusp Low Dose + Nivolumab, Arm B: Brenetafusp High Dose + Nivolumab |
| NivolumabAlso: OPDIVOConcentrate for solution for infusion at a unit dose of 10 mg/mL. | Drug | Arm A: Brenetafusp Low Dose + Nivolumab, Arm B: Brenetafusp High Dose + Nivolumab, Arm C: Nivolumab OR Nivolumab + Relatlimab |
| Nivolumab + RelatlimabAlso: OPDUALAGConcentrate for solution for infusion at a unit dose of 16 mg/mL. | Drug | Arm C: Nivolumab OR Nivolumab + Relatlimab |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to ~45 months
PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
9 secondary outcomes
Overall Survival (OS)
Time frame: Up to ~57 months
Overall Response Rate (ORR)
Time frame: Up to ~45 months
Number of Participants Experiencing ≥1 Adverse Event (AE)
Time frame: Up to ~57 months
Number of Participants Experiencing ≥1 Serious Adverse Event (SAE)
Time frame: Up to ~57 months
Number of Participants Experiencing a Dose Interruption, Reduction, or Discontinuation
Time frame: Up to ~45 months
Maximum Plasma Concentration (Cmax) of IMC-F106C
Time frame: Day 1 of Weeks 1, 2, and 3: Predose and 0.5 and 4 hours postdose
Incidence of anti-IMC-F106C Antibodies
Time frame: Up to ~45 months
Association between PFS and Intra-Tumor Immune Cells
Time frame: Up to ~45 months
Health-Related Quality of Life
Time frame: Up to ~45 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
211 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brenetafusp, Nivolumab and Nivolumab + Relatlimab in people with Advanced Melanoma, run by Immunocore Ltd at 211 sites in 26 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 211 sites in United States, Spain, Germany, Italy, Turkey (Türkiye) and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Immunocore Medical Information (844-466-8661, medical.information@immunocore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to ~45 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.