Trial Title:
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
NCT ID:
NCT06112314
Condition:
Advanced Melanoma
Conditions: Official terms:
Melanoma
Nivolumab
Relatlimab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
IMC-F106C
Description:
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.
Arm group label:
Arm A: IMC-F106C Low Dose + Nivolumab
Arm group label:
Arm B: IMC-F106C High Dose + Nivolumab
Intervention type:
Biological
Intervention name:
Nivolumab
Description:
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
Arm group label:
Arm A: IMC-F106C Low Dose + Nivolumab
Arm group label:
Arm B: IMC-F106C High Dose + Nivolumab
Arm group label:
Arm C: Nivolumab OR Nivolumab + Relatlimab
Other name:
OPDIVO
Intervention type:
Biological
Intervention name:
Nivolumab + Relatlimab
Description:
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
Arm group label:
Arm C: Nivolumab OR Nivolumab + Relatlimab
Other name:
OPDUALAG
Summary:
This is a phase 3, randomized, controlled study of IMC-F106C plus nivolumab compared to
standard nivolumab regimens in HLA-A*02:01-positive participants with previously
untreated advanced melanoma.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Angeles Clinic and Research Institute- West Los Angeles
Address:
City:
Los Angeles
Zip:
90025
Country:
United States
Status:
Recruiting
Contact:
Last name:
Saba Mukarram
Phone:
310-231-2181
Email:
SMukarram@theangelesclinic.org
Facility:
Name:
ESC Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sandy Tran
Phone:
323-865-3935
Email:
Sandy.tran@med.usc.edu
Facility:
Name:
UCLA Hematology/Oncology
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Crocker
Phone:
310-794-3266
Email:
JCrocker@mednet.ucla.edu
Facility:
Name:
University of Colorado, Anschutz Medical Campus
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kayla Vondran
Phone:
720-848-9381
Email:
KAYLA.VONDRAN@CUANSCHUTZ.EDU
Facility:
Name:
Mayo Clinic Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heidi Turner
Phone:
904-953-5323
Email:
Turner.Heidi@mayo.edu
Facility:
Name:
Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Linnea Drew
Phone:
617-632-6704
Email:
linneam_drew@dfci.harvard.edu
Facility:
Name:
John Theurer Cancer Center at Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwell Health Cancer Institute
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sarilee Liz
Email:
sliz@northwell.edu
Facility:
Name:
Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Nurse Navigators
Phone:
212-342-5162
Email:
cancerclinicaltrials@cumc.columbia.edu
Facility:
Name:
Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Madeleine Martinelli
Phone:
267-414-8820
Email:
Madeleine.martinelli@jefferson.edu
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelly Schroder
Phone:
412-623-3544
Email:
schroderka@upmc.edu
Facility:
Name:
Prisma Health Cancer Institute
Address:
City:
Greenville
Zip:
29605
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisa Johnson
Email:
Lisa.johnson@prismahealth.org
Facility:
Name:
Swedish Medical Center - Swedish Cancer Institute (SCI) - First Hill Campus
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Contact:
Last name:
CancerResearch
Phone:
206-215-3125
Email:
cancerresearch@swedish.org
Facility:
Name:
Sanatorio Finochietto
Address:
City:
Caba
Zip:
1213
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Dr. Gabriela Cinat
Phone:
541158216233
Email:
gabriela_cinat@yahoo.com.ar
Facility:
Name:
Clínica Adventista Belgrano - Sector Investigación
Address:
City:
Caba
Zip:
C1430EGF
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Aldo A. Perfetti
Phone:
5491132682903
Email:
aaperfetti@yahoo.com.ar
Facility:
Name:
Instituto Alexander Fleming
Address:
City:
Caba
Zip:
CP1426ANZ
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Clinica Viedma
Address:
City:
Viedma
Zip:
R8500ACE
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Ruben Kowalyszyn
Phone:
542920601693
Email:
kowar@rnonline.com.ar
Facility:
Name:
Gallipoli Medical Research Foundation (Greenslopes Private Hospital)
Address:
City:
Greenslopes
Zip:
4120
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Gallipoli Research
Phone:
+61 7 3394 7284
Email:
Enquiries.GMR@gallipoliresearch.org.au
Facility:
Name:
Austin Hospital
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
North Melbourne
Zip:
3051
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Dr Lavinia Spain
Phone:
61385595000
Email:
Enquiries.GMR@gallipoliresearch.org.au
Facility:
Name:
University of Sydney - Melanoma Institute Australia (MIA) - The Poche Centre
Address:
City:
Wollstonecraft
Country:
Australia
Status:
Recruiting
Facility:
Name:
The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)
Address:
City:
Woolloongabba
Country:
Australia
Status:
Recruiting
Facility:
Name:
Universitätsklinikum St. Pölten
Address:
City:
Pölten
Country:
Austria
Status:
Recruiting
Facility:
Name:
Paracelsus Medizinischen Privatuniversitaet - SALK - Universitaetsklinik fuer Dermatologie - EB-Haus Austria
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Uni Hospital
Address:
City:
Panagyurishte
Zip:
4500
Country:
Bulgaria
Status:
Recruiting
Contact:
Last name:
Milena Kardaleva
Phone:
359888844526
Email:
kardaleva@gmail.com
Facility:
Name:
Complex Oncology Center - Plovdiv Ltd.
Address:
City:
Plovdiv
Zip:
4000
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
Regina Life Clinic
Address:
City:
Sofia
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
Sanatorium Profesora Arenbergera
Address:
City:
Praha
Zip:
110 00
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Tereza Kralova
Phone:
420737806453
Email:
tereza.kralova@crc-cz.com
Facility:
Name:
Kobenhavns Universitet - Herlev Hospital (Amtssygehuset i Herlev)
Address:
City:
Herlev
Zip:
2730
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Inge Marie Svane
Phone:
004538362131
Email:
inge.marie.svane@regionh.dk
Facility:
Name:
Hôpital de la Timone
Address:
City:
Marseille
Zip:
13385
Country:
France
Status:
Recruiting
Facility:
Name:
Oncopole Claudius Regaud- Institut Universitaire du Cancer de Toulouse
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Facility:
Name:
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Seine-Saint-Denis - Hopital Avicenne
Address:
City:
Bobigny
Zip:
93000
Country:
France
Status:
Recruiting
Facility:
Name:
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Ambroise-Pare
Address:
City:
Boulogne-Billancourt
Zip:
92104
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de Dijon Bourgogne - Hôpital François Mitterrand
Address:
City:
Dijon
Country:
France
Status:
Recruiting
Contact:
Last name:
Meryem DEBBABI
Phone:
33380293842
Email:
meryem.debbabi@chu-dijon.fr
Contact backup:
Last name:
Elisabeth CORNOT
Phone:
33380669466
Email:
elisabeth.cornot@chu-dijon.fr
Facility:
Name:
Centre Hospitalier Universitaire de Lille (CHU Lille)-Hopital Claude Huriez
Address:
City:
Lille
Zip:
59037
Country:
France
Status:
Recruiting
Contact:
Last name:
Pr Laurent Mortier
Phone:
0033320444193
Email:
laurent.mortier@chu-lille.fr
Facility:
Name:
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Address:
City:
Nantes
Country:
France
Status:
Recruiting
Facility:
Name:
Hospital Saint Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Recruiting
Facility:
Name:
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Address:
City:
Pierre-Benite
Zip:
69310
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Hopital Charles-Nicolle
Address:
City:
Rouen
Zip:
76031
Country:
France
Status:
Recruiting
Contact:
Last name:
Orlane DEBOVES
Phone:
0232886699
Email:
orlane.deboves@chu-rouen.fr
Contact backup:
Last name:
Raphaëlle DAVESNE
Phone:
0232886699
Email:
raphaelle.davesne@chu-rouen.fr
Facility:
Name:
Hopital Robert Debre
Address:
City:
Valence
Zip:
26000
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Gustave Roussy (IGR) Service de Dermatolgie
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Facility:
Name:
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Dermatologie Venerologie und Allergologie - Hauttumorcentrum Charite (HTCC)
Address:
City:
Berlin
Zip:
10115
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Max Schlaak, MD
Phone:
4930450518448
Email:
studien-hauttumorcentrum@charite.de
Contact backup:
Last name:
Max Schlaak, MD
Phone:
4930450518309
Email:
studien-hauttumorcentrum@charite.de
Facility:
Name:
Universitaetsklinikum Essen
Address:
City:
Essen
Zip:
45122
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Jessica Bauriedl
Phone:
02017232325
Email:
Jessica.bauriedl@uk-essen.de
Facility:
Name:
University of Hamburg
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Prof. Dr. Gebhardt
Phone:
4940741057626
Email:
Studien-htz@uke.de
Facility:
Name:
Elbe Kliniken Stade - Hautkrebszentrum Buxtehude
Address:
City:
Hamburg
Zip:
22045
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Uta Haisch
Phone:
4941617036212
Email:
Uta.Haisch@elbekliniken.de
Facility:
Name:
Universitaetsklinikum Heidelberg (UKHD) - Hautklinik
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Prof. Jessica Hassel, MD
Phone:
496221568562
Email:
NCT.DermaOnko@med.uni-heidelberg.de
Facility:
Name:
Universitaetsklinikum Leipzig - Klinik fuer Dermatologie, Venerologie und Allergologie
Address:
City:
Leipzig
Zip:
4103
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Jan Christoph Simon, MD
Phone:
00493419718600
Email:
Jan.simon@medizin.uni-leipzig.de
Facility:
Name:
Johannes Wesling Klinikum Minden
Address:
City:
Minden
Zip:
32429
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Yenny Angela
Phone:
57179054523
Email:
yenny.angela@muehlenkreiskliniken.de
Facility:
Name:
Universitaetsklinikum Tuebingen (UKT) - Zentrum fuer Dermatoonkologie - Hautklinik
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Teresa Amaral, MD, PhD
Phone:
004970712985748
Email:
Teresa.amaral@med.uni-tuebingen.de
Facility:
Name:
Universitaetsklinikum Wuerzburg - Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie
Address:
City:
Würzburg
Zip:
97080
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Anja Gesierich, MD
Phone:
4993120126762
Email:
Gesierich_A@ukw.de
Facility:
Name:
Pecsi Tudomanyegyetem (PTE) (University of Pecs)
Address:
City:
Pécs
Zip:
7624
Country:
Hungary
Status:
Recruiting
Contact:
Last name:
Zsuzsanna Lengyel, MD
Phone:
36303599887
Email:
lengyel.zsuzsanna@pte.hu
Facility:
Name:
Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Recruiting
Facility:
Name:
IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST)
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)
Address:
City:
Milan
Zip:
20141
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Raffaella Ghisini
Email:
raffaella.ghisini@ieo.it
Facility:
Name:
Istituto Nazionale Tumori (INT) "Fondazione G. Pascale" di Napoli
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Oncologico Veneto (IOV) IRCCS
Address:
City:
Padova
Zip:
I-35128
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Sanitaria Locale di Biella (ASL BI) - Ospedale degli Infermi
Address:
City:
Ponderano
Zip:
13875
Country:
Italy
Status:
Recruiting
Facility:
Name:
" Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte - Clinica Immunoterapia Oncologica"
Address:
City:
Siena
Zip:
53100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Centrum Onkologii im. Prof. Franciszka Łukaszczyka
Address:
City:
Bydgoszcz
Zip:
85796
Country:
Poland
Status:
Recruiting
Facility:
Name:
Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne
Address:
City:
Gdansk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Izabela Gudewicz
Email:
izabelagudewicz@gumed.edu.pl
Facility:
Name:
Centrum Medyczne Pratia Poznań - Skorzewo
Address:
City:
Skorzewo
Zip:
60185
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Katarzyna Karpisiak
Phone:
48512491461
Email:
katarzyna.karpisiak@pratia.com
Facility:
Name:
Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Beata Wielgocka
Phone:
225462603
Email:
beata.wielgocka@pib-nio.pl
Facility:
Name:
Sf Nectarie Oncology Center
Address:
City:
Craiova
Zip:
200542
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Augustin Gheorghe
Phone:
40723557512
Email:
gusti.gheorghe@yahoo.com
Facility:
Name:
Universidad de Murcia - Hospital Universitario Virgen de la Arrixaca (HUVA)
Address:
City:
El Palmar
Zip:
30120
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Paula Ruiz Carreño
Phone:
0034968369387
Email:
dm.oncoarrixaca2@gmail.com
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Dexeus
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Zip:
8036
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Nadina Fradera
Phone:
0034687727943
Email:
fradera@recerca.clinic.cat
Facility:
Name:
Hospital Universitario Virgen de las Nieves (HUVN)
Address:
City:
Granada
Zip:
18014
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Isabel Rodriguez
Phone:
0034 958 145 591
Phone ext:
179591
Email:
i_rodriguez_gonzalez@hotmail.es
Facility:
Name:
Hospital Universitario Ramon y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Yolanda Álvarez Pérez
Phone:
917277516
Email:
yolandalapaz@gmail.com
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen Macarena
Address:
City:
Seville
Zip:
41009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Mónica Suengas
Phone:
697958425
Email:
moni.suengas@gmail.com
Facility:
Name:
Hospital Clinico Universitario de Valencia
Address:
City:
Valencia
Zip:
46014
Country:
Spain
Status:
Recruiting
Facility:
Name:
Sahlgrenska Akademin - Institutionen for Kliniska Vetenskaper (Institute of Clinical Sciences)
Address:
City:
Göteborg
Zip:
SE41345
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Uppsala Universitet - Akademiska Sjukhuset (Uppsala University Hospital)
Address:
City:
Uppsala
Zip:
SE75185
Country:
Sweden
Status:
Recruiting
Facility:
Name:
UniversitaetsSpital Zuerich - Dermatologische Klinik
Address:
City:
Zurich
Zip:
8901
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Prof. Dr. med Reinhard Dummer, MD
Phone:
41442552507
Email:
Reinhard.dummer@usz.ch
Facility:
Name:
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH) - Oncology Centre
Address:
City:
Cambridge
Zip:
CB20QQ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Beatson West of Scotland Cancer Centre
Address:
City:
Glasgow
Zip:
G12 0YN
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Dr Pavlina Spiliopoulou, MD
Phone:
0141 301 7043
Email:
pavlina.spiliopoulou2@nhs.scot
Facility:
Name:
The Clatterbridge Cancer Centre NHS Foundation Trust
Address:
City:
Liverpool
Zip:
L78YA
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Pembe Yeslidag
Phone:
01515565435
Email:
pembe.yesildag@nhs.net
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Zip:
M204BX
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Royal Marsden Hospital - Sutton
Address:
City:
Surrey Quays
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Start date:
December 18, 2023
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Immunocore Ltd
Agency class:
Industry
Source:
Immunocore Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06112314
