Clinical trial NCT06112314: IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Advanced Melanoma
Lead sponsor: Immunocore Ltd
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Criteria:

* Participants must be HLA-A\*02:01-positive
* Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma
* Archived or fresh tumor tissue sample that must be confirmed as adequate
* Participants must have measurable disease per RECIST 1.1
* Participant must have BRAF V600 mutation status determined
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention

Exclusion Criteria:

* Participants with a history of a malignant disease other than those being treated in this study
* Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis
* Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
* Participants with clinically significant pulmonary disease or impaired lung function
* Participants with clinically significant cardiac disease or impaired cardiac function
* Participants with active autoimmune disease requiring immunosuppressive treatment
* Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
* Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma
* Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to ~45 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to ~57 months
measure: Overall Response Rate (ORR)
timeFrame: Up to ~45 months
measure: Number of Participants Experiencing ≥1 Adverse Event (AE)
timeFrame: Up to ~57 months
measure: Number of Participants Experiencing ≥1 Serious Adverse Event (SAE)
timeFrame: Up to ~57 months
measure: Number of Participants Experiencing a Dose Interruption, Reduction, or Discontinuation
timeFrame: Up to ~45 months
measure: Maximum Plasma Concentration (Cmax) of IMC-F106C
timeFrame: Day 1 of Weeks 1, 2, and 3: Predose and 0.5 and 4 hours postdose
measure: Incidence of anti-IMC-F106C Antibodies
timeFrame: Up to ~45 months
measure: Association between PFS and Intra-Tumor Immune Cells
timeFrame: Up to ~45 months
measure: Health-Related Quality of Life
timeFrame: Up to ~45 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California - San Diego
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute- West Los Angeles
state: California
city: Los Angeles
country: United States
facility: ESC Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Institute - Stanford Cancer Center Palo Alto
state: California
city: Santa Monica
country: United States
facility: Saint John's Health Center - John Wayne Cancer Institute (JWCI)
state: California
city: Aurora
country: United States
facility: University of Colorado, Anschutz Medical Campus
state: Colorado
city: Farmington
country: United States
facility: UConn Health-Farmington (University of Connecticut Health Center (UCHC))
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Miami
country: United States
facility: University of Miami Health System-Sylvester Comprehensive Cancer Center-Miami
state: Florida
city: Chicago
country: United States
facility: Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI
state: Illinois
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare - Edgewood
state: Kentucky
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Lake Success
country: United States
facility: Northwell Health Cancer Institute
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health Cancer Institute
state: South Carolina
city: Charlottesville
country: United States
facility: UVA Health-UVA Emily Couric Clinical Cancer Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center - Swedish Cancer Institute (SCI) - First Hill Campus
state: Washington
city: Caba
country: Argentina
facility: Sanatorio Finochietto
state: Buenos Aires
city: Caba
country: Argentina
facility: Clínica Adventista Belgrano - Sector Investigación
state: Buenos Aires
city: Caba
country: Argentina
facility: Instituto Alexander Fleming
city: Viedma
country: Argentina
facility: Clinica Viedma
city: Waratah
country: Australia
facility: Calvary Mater Newcastle Hospital
state: New South Wales
city: Greenslopes
country: Australia
facility: Gallipoli Medical Research Foundation (Greenslopes Private Hospital)
state: Queensland
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Nedlands
country: Australia
facility: One Clinical Research - Nedlands
state: Western Australia
city: Heidelberg
country: Australia
facility: Austin Hospital
city: North Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: Wollstonecraft
country: Australia
facility: University of Sydney - Melanoma Institute Australia (MIA) - The Poche Centre
city: Woolloongabba
country: Australia
facility: The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)
city: Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
city: Salzburg
country: Austria
facility: Paracelsus Medizinischen Privatuniversitaet - SALK - Universitaetsklinik fuer Dermatologie - EB-Haus Austria
city: Anderlecht
country: Belgium
facility: Universite Libre de Bruxelles (ULB)-Institut Jules Bordet
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV-Campus Sint-Jan
city: Leuven
country: Belgium
facility: UZ Leuven
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Ltda
state: RS
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
city: Brasília
country: Brazil
facility: Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia
city: Florianópolis
country: Brazil
facility: Centro de Pesquisas Oncologicas (CEPON)
city: Fortaleza
country: Brazil
facility: Oncocentro Sao Carlos Hospital
city: Liberdade
country: Brazil
facility: A.C.Camargo Cancer Center - Centro Internacional de Pesquisa (CIPE)
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre (HCPA)
city: Porto Alegre
country: Brazil
facility: Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Hospital Sao Lucas - Centro de Pesquisa Clinica (CPC)
city: Rio De Janeiro
country: Brazil
facility: National Cancer Institute
city: Rio De Janeiro
country: Brazil
facility: Instituto Américas - Instituto de Educação Pesquisa e Gestão em Saúde Oncosite
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo (ICESP)
city: São Paulo
country: Brazil
facility: Hospital 9 de Julho
city: São Paulo
country: Brazil
facility: Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP) - Hospital de Base (HB) - Centro Integrado de Pesquisa (CIP)
city: Panagyurishte
country: Bulgaria
facility: Uni Hospital
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center - Plovdiv Ltd.
city: Sofia
country: Bulgaria
facility: University Hospital Tsaritsa Yoanna (ISUL) (Queen Giovanna University Hospital)
city: Sofia
country: Bulgaria
facility: Regina Life Clinic
city: Edmonton
country: Canada
facility: Cross Cancer Institute
city: Hradec Králové
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove (FNHK) - Klinika Onkologie a Radioterapie
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc (FNOL)
city: Praha
country: Czechia
facility: Sanatorium Profesora Arenbergera
city: Herlev
country: Denmark
facility: Kobenhavns Universitet - Herlev Hospital (Amtssygehuset i Herlev)
city: Marseille
country: France
facility: Hôpital de la Timone
state: Cedex
city: Toulouse
country: France
facility: Oncopole Claudius Regaud- Institut Universitaire du Cancer de Toulouse
state: Cedex
city: Bobigny
country: France
facility: Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Seine-Saint-Denis - Hopital Avicenne
city: Boulogne-Billancourt
country: France
facility: Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Ambroise-Pare
city: Caen
country: France
facility: UNICANCER-Centre Francois Baclesse (CFB)
city: Dijon
country: France
facility: CHU de Dijon Bourgogne - Hôpital François Mitterrand
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille (CHU Lille)-Hopital Claude Huriez
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
city: Paris
country: France
facility: Hospital Saint Louis
city: Pierre-Benite
country: France
facility: Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
city: Rouen
country: France
facility: Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Hopital Charles-Nicolle
city: Valence
country: France
facility: Hopital Robert Debre
city: Villejuif
country: France
facility: Institut Gustave Roussy (IGR) Service de Dermatolgie
city: Berlin
country: Germany
facility: Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Dermatologie Venerologie und Allergologie - Hauttumorcentrum Charite (HTCC)
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt - Klinik fuer Hautkrankheiten und Allergologie
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe-Universitaet Frankfurt am Main - Klinik fuer Dermatologie, Venerologie und Allergologie
city: Gießen
country: Germany
facility: Justus-Liebig-Universitaet Giessen - Klinik fuer Dermatologie und Andrologie
city: Hamburg
country: Germany
facility: University of Hamburg
city: Hamburg
country: Germany
facility: Elbe Kliniken Stade - Hautkrebszentrum Buxtehude
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg (UKHD) - Hautklinik
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig - Klinik fuer Dermatologie, Venerologie und Allergologie
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Munich
country: Germany
facility: LMU Klinikum - Klinik und Poliklinik fur Dermatologie und Allergologie
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen (UKT) - Zentrum fuer Dermatoonkologie - Hautklinik
city: Würzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg - Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Általános Orvostudományi Kar
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem (PTE) (University of Pecs)
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem (University of Szeged)
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni (Cliniche Gavazzeni S.p.A)
city: Meldola
country: Italy
facility: IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST)
city: Milano
country: Italy
facility: Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori (INT) "Fondazione G. Pascale" di Napoli
city: Padova
country: Italy
facility: Istituto Oncologico Veneto (IOV) IRCCS
city: Padova
country: Italy
facility: Istituto Oncologico Veneto (IOV) IRCCS
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
city: Ponderano
country: Italy
facility: Azienda Sanitaria Locale di Biella (ASL BI) - Ospedale degli Infermi
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Siena
country: Italy
facility: " Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte - Clinica Immunoterapia Oncologica"
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Łukaszczyka
city: Gdansk
country: Poland
facility: Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznań - Skorzewo
city: Warszawa
country: Poland
facility: Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków
city: Cluj-Napoca
country: Romania
facility: L'Institute Oncologique Prof. Dr. Ion Chiricuta (IOCN) (The Oncology Institute Prof. Dr. Ion. Chiricuta)
city: Craiova
country: Romania
facility: Sf Nectarie Oncology Center
city: Santander
country: Spain
facility: Universidad de Cantabria (UC) - Hospital Universitario Marques de Valdecilla (HUMV)
state: Cantabria
city: El Palmar
country: Spain
facility: Universidad de Murcia - Hospital Universitario Virgen de la Arrixaca (HUVA)
state: Murcia
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruna (CHUAC)
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Universitario Dexeus
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves (HUVN)
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid (UCM)-Hospital Universitario 12 de Octubre (H12O)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal (CIOCC)
city: Pamplona
country: Spain
facility: Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Seville
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
city: Göteborg
country: Sweden
facility: Sahlgrenska Akademin - Institutionen for Kliniska Vetenskaper (Institute of Clinical Sciences)
city: Jönköping
country: Sweden
facility: Lanssjukhuset Ryhov - Onkologiska Kliniken
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus - Lund - Onkologiska Klinik
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Uppsala
country: Sweden
facility: Uppsala Universitet - Akademiska Sjukhuset (Uppsala University Hospital)
city: Zurich
country: Switzerland
facility: UniversitaetsSpital Zuerich - Dermatologische Klinik
city: Çankaya
country: Turkey
facility: Memorial Saglik Grubu - Memorial Ankara Hastanesi
state: Ankara
city: Antalya
country: Turkey
facility: Medical Park Hastaneler Grubu - I.A.U. VM Medical Park Florya
state: Campus
city: Bahçelievler
country: Turkey
facility: Memorial Saglik Grubu - Memorial Bahcelievler Hastanesi
state: Istanbul
city: Altındağ
country: Turkey
facility: Kanser Enstitusu (Hacettepe University Cancer Institute)
city: Ankara
country: Turkey
facility: T.C. Saglik Bakanligi - SBU Gulhane Egitim ve Arastirma Hastanesi
city: Malatya
country: Turkey
facility: Inonu Universitesi - Turgut Ozal Tip Merkezi
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi (OMU) - Tip Facultesi
city: Seyhan
country: Turkey
facility: Medical Park Seyhan Hastanesi
city: Yenimahalle
country: Turkey
facility: T.C. Saglik Bakanligi - Ankara Etlik sehir Hastanesi
city: Çankaya
country: Turkey
facility: Ankara Bilkent City Hospital, Oncology Department
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH) - Oncology Centre
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Liverpool
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute (SCRI) - London (SCRI-UK)
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Surrey Quays
country: United Kingdom
facility: Royal Marsden Hospital - Sutton
Study officials:
References: