Trial Title:
A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery
NCT ID:
NCT05608291
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Pembrolizumab
Cemiplimab
Conditions: Keywords:
Resected High Risk Melanoma
Skin Cancer
Stage IIB
Stage IIC
Stage III
Stage IV
LAG-3 Lymphocyte activation gene 3
Adjuvant Setting
anti-PD-1 Monoclonal Antibody
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Fianlimab
Description:
Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks
Arm group label:
Fianlimab HD + Cemiplimab
Arm group label:
Fianlimab LD + Cemiplimab
Other name:
REGN3767
Intervention type:
Drug
Intervention name:
Cemiplimab
Description:
Cemiplimab will be administered by IV infusion Q 3 weeks
Arm group label:
Fianlimab HD + Cemiplimab
Arm group label:
Fianlimab LD + Cemiplimab
Other name:
REGN2810
Other name:
Libtayo
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab will be administered by IV infusion Q 3 weeks
Arm group label:
Pembrolizumab
Other name:
MK-3475
Other name:
lambrolizumab
Other name:
Keytruda
Intervention type:
Drug
Intervention name:
Placebo
Description:
Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q
3 weeks
Arm group label:
Pembrolizumab
Summary:
This study is researching an experimental drug called REGN3767, also known as fianlimab
(R3767), when combined with another medication called cemiplimab (each individually
called a "study drug" or called "study drugs" when combined) compared with an approved
medication called pembrolizumab.
The objective of this study is to see if the combination of fianlimab and cemiplimab is
an effective treatment compared to pembrolizumab in patients that have had melanoma
removal surgery but are still at high risk for the recurrence of the disease.
Pembrolizumab is an approved treatment in some countries in this clinical setting.
The study is looking at several other research questions, including:
- What side effects may happen from receiving the study drugs.
- How much study drug is in the blood at different times.
- Whether the body makes antibodies against the study drug (which could make the drug
less effective or could lead to side effects). Antibodies are proteins that are
naturally found in the blood stream that fight infections.
- How administering the study drugs might improve quality of life.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. All patients must be either stage IIB, IIC, III, or stage IV per American Joint
Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma
that is completely surgically resected in order to be eligible as defined by the
protocol
2. Complete surgical resection must be performed within 12 weeks prior to
randomization, and enrollment may occur only after satisfactory wound healing from
the surgery
3. All patients must have disease-free status documented by a complete physical
examination and imaging studies within 4 weeks prior to randomization, as described
in the protocol
Key Exclusion Criteria:
1. Uveal melanoma
2. Any evidence of residual disease after surgery by imaging, pathology, or cytology.
3. Ongoing or recent (within 2 years) evidence of clinically significant autoimmune
disease that required treatment
4. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus
(HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is
related to, or results in chronic infection, as described in the protocol
5. Another malignancy that is currently progressing or that required active treatment
in the past 5 years, as described in the protocol
6. Participants with a history of myocarditis
7. Adolescent patients (≥12 to <18 years old) with body weight <40 kg
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California San Diego
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94158-3214
Country:
United States
Status:
Recruiting
Facility:
Name:
John Wayne Cancer Institute - Saint John's Health Center
Address:
City:
Santa Monica
Zip:
90404-2312
Country:
United States
Status:
Recruiting
Facility:
Name:
The Melanoma And Skin Cancer Institute
Address:
City:
Englewood
Zip:
80113
Country:
United States
Status:
Recruiting
Facility:
Name:
Miami Cancer Institute
Address:
City:
Miami
Zip:
33176
Country:
United States
Status:
Recruiting
Facility:
Name:
Orlando Health Cancer Institute
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwestern Medical Group
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts General Cancer Center
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana-Farber Cancer institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Rochester
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Recruiting
Facility:
Name:
Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
St. Luke's Hematology
Address:
City:
Easton
Zip:
18045
Country:
United States
Status:
Recruiting
Facility:
Name:
Thomas Jefferson University Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Withdrawn
Facility:
Name:
University of Tennessee Medical Center
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI Partners - Verdi Oncology
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Tennessee Oncology
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Facility:
Name:
Intermountain Medical Center
Address:
City:
Murray
Zip:
84107
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Virginia Health System
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialist Research Institute
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Withdrawn
Facility:
Name:
Fundacion CENIT para la investigacion en Neurociencias
Address:
City:
Ciudad Autonoma
Zip:
C1125ABD
Country:
Argentina
Status:
Recruiting
Facility:
Name:
DIABAID - Instituto de Asistencia Integral en Diabetes
Address:
City:
Ciudad Autonoma
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Clinica Viedma S.A.
Address:
City:
Viedma
Zip:
8500
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Centro de Investigacion Pergamino SA
Address:
City:
Rosario
Zip:
S2000KZE
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Instituto de Oncologia de Rosario - Departamento de Investigaciones
Address:
City:
Rosario
Zip:
S2000KZE
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Centro Medico San Roque
Address:
City:
San Miguel de Tucumán
Zip:
4000
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Lismore Base Hospital
Address:
City:
Lismore
Zip:
2480
Country:
Australia
Status:
Recruiting
Facility:
Name:
Liverpool Hospital (Cancer Therapy Pharmacy)
Address:
City:
Liverpool
Zip:
2170
Country:
Australia
Status:
Recruiting
Facility:
Name:
Calvary North Adelaid Hospital (HPS Pharmacies)
Address:
City:
Adelaide
Zip:
5006
Country:
Australia
Status:
Recruiting
Facility:
Name:
Flinders Medical Centre
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Facility:
Name:
Box Hill Hospital
Address:
City:
Box Hill
Zip:
3128
Country:
Australia
Status:
Recruiting
Facility:
Name:
Andrew Love Cancer Centre, University Hospital Geelong
Address:
City:
Geelong
Zip:
3220
Country:
Australia
Status:
Recruiting
Facility:
Name:
Alfred Health
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Facility:
Name:
One Clinical Research
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
VITAZ vzw
Address:
City:
Sint Niklaas
Zip:
9100
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Cliniques Universitaires Saint-Luc
Address:
City:
Brussels
Zip:
1200
Country:
Belgium
Status:
Withdrawn
Facility:
Name:
Campus Kennedylaan Apotheek
Address:
City:
Kortrijk
Zip:
8500
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Centro Avancado de Tratamento Oncologico (CENANTRON)
Address:
City:
Belo Horizonte
Zip:
30130-090
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Erasto Gaertner
Address:
City:
Curitiba
Zip:
81520-060
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA)
Address:
City:
Barra da Tijuca
Zip:
2279-080
Country:
Brazil
Status:
Recruiting
Facility:
Name:
INCA - Brazilian National Cancer Institute
Address:
City:
Santo Cristo
Zip:
20220-410
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Oncosite Centro De Pesquisa Clinica Em Oncologia
Address:
City:
Ijui
Zip:
98700-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Sao Vicente de Paulo - Instituto do Cancer
Address:
City:
Passo Fundo
Zip:
99010-080
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Associacao Hospitalar Moinhos de Vento, Centro de Pesquisa Clinica
Address:
City:
Porto Alegre
Zip:
90035-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital de Clinicas de Porto Alegre - UPCO- pesquisa Clinica em Oncologia do HCPA
Address:
City:
Porto Alegre
Zip:
90035-903
Country:
Brazil
Status:
Recruiting
Facility:
Name:
CPO - Centro de Pesquisas em Oncologia
Address:
City:
Porto Alegre
Zip:
90610-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Clinica de Neoplasias Litoral
Address:
City:
Itajai
Zip:
88301-220
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto Joinvilense de Hematologia e Oncologia
Address:
City:
Joinville
Zip:
89201-260
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Animi Unidade de Tratamento Oncologico Ltda
Address:
City:
Lages
Zip:
88501-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto de Ensino e Pesquisas Sao Lucas - IEP HEMOMED
Address:
City:
Sao Paulo
Zip:
01236-030
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundacao Pio XII - Hospital de Cancer de Barretos
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Sirio-Libanes
Address:
City:
Sao Paulo
Zip:
01308-050
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Nucleo de Pesquisa da Rede Sao Camilo (Instituto Brasileiro de Controle do Cancer)
Address:
City:
Sao Paulo
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Dr. Everett Chalmers Hospital
Address:
City:
Fredericton
Zip:
E3B5N5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Royal Victoria Regional Health Centre
Address:
City:
Barrie
Zip:
L4M 6M2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Sunnybrook Research Institute
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Recruiting
Facility:
Name:
University Health Network, Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2C1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Universidad Mayor - Centro Oncologia de Precision (PROFAR)
Address:
City:
Santiago
Zip:
7560907
Country:
Chile
Status:
Recruiting
Facility:
Name:
Clinica UC San Carlos de Apoquindo
Address:
City:
Santiago
Zip:
7620002
Country:
Chile
Status:
Recruiting
Facility:
Name:
Oncovida
Address:
City:
Santiago
Zip:
7510032
Country:
Chile
Status:
Recruiting
Facility:
Name:
Oncocentro APYS
Address:
City:
Valparaiso
Zip:
2520598
Country:
Chile
Status:
Recruiting
Facility:
Name:
University Hospital Hradec Kralove
Address:
City:
Hradec Kralove
Zip:
50005
Country:
Czechia
Status:
Recruiting
Facility:
Name:
University Hospital Ostrava Pharmacy
Address:
City:
Ostrava
Zip:
70852
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Masaryk Memorial Cancer Institute, Hospital Pharmacy
Address:
City:
Brno
Zip:
65653
Country:
Czechia
Status:
Recruiting
Facility:
Name:
CHU de DIJON - Pharmacie Essais Cliniques
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Georges Francois Leclerc
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Jean Minjoz
Address:
City:
Besancon Cedex
Zip:
25030
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Grenoble Alpes
Address:
City:
La Tronche
Zip:
38700
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Claudius Regaud - Pharmacie
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Saint Louis - APHP, Service de Pharmacie - Niveau
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Lille, Pharmacie Centrale
Address:
City:
Lille
Zip:
59037
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Francois Baclesse
Address:
City:
Caen
Zip:
14076
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Saint Andre, Pharmacie
Address:
City:
Bordeaux
Zip:
33075
Country:
France
Status:
Recruiting
Facility:
Name:
Unite de Pharmacie Clinique Oncologique (UPCO)
Address:
City:
Montpellier
Zip:
34090
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Ambroise Pare
Address:
City:
Boulogne Billancourt
Zip:
92100
Country:
France
Status:
Recruiting
Facility:
Name:
CHU HENRI MONDOR Pharmacie Secteur ESSAIS CLINIQUES
Address:
City:
Creteil
Zip:
94000
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de NANTES Hotel Dieu
Address:
City:
Nantes
Zip:
44000
Country:
France
Status:
Recruiting
Facility:
Name:
Sainte Catherine Institut du Cancer Avignon Provence
Address:
City:
Avignon
Zip:
84918
Country:
France
Status:
Withdrawn
Facility:
Name:
CHU G. Montpied, Pharmacie, secteur recherche clinique
Address:
City:
Clermont-Ferrand
Zip:
63003
Country:
France
Status:
Recruiting
Facility:
Name:
CH Le Mans - CCS Pharmacie-essais cliniques, aile B
Address:
City:
Le Mans
Zip:
72037
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Avicenne Service Pharmacie Secteur essais cliniques
Address:
City:
Bobigny
Zip:
93000
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Amiens-Picardie Site Sud
Address:
City:
Amiens
Zip:
80054
Country:
France
Status:
Recruiting
Facility:
Name:
Gustave Roussy - Pharmacie Essais Cliniques -1
Address:
City:
Vaillant
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire de Nice,Hopital l Archet
Address:
City:
Nice
Zip:
06200
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Charles Nicolle
Address:
City:
Rouen
Zip:
76031
Country:
France
Status:
Withdrawn
Facility:
Name:
LTD Cancer Center of Adjara Autonomic Republic
Address:
City:
Batumi
Zip:
6000
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Israeli Georgian medical research clinic Helsicore
Address:
City:
T'bilisi
Zip:
0112
Country:
Georgia
Status:
Recruiting
Facility:
Name:
LTD Research Institute of Clinical Medicine (LLC Todua Clinic)
Address:
City:
T'bilisi
Zip:
0112
Country:
Georgia
Status:
Recruiting
Facility:
Name:
LTD New Hospitals
Address:
City:
T'bilisi
Zip:
0114
Country:
Georgia
Status:
Recruiting
Facility:
Name:
High Technology Medical Center, University Clinic Tbilisi
Address:
City:
T'bilisi
Zip:
0144
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Tbilisi Institute of Medicine (TIM)
Address:
City:
T'bilisi
Zip:
0168
Country:
Georgia
Status:
Recruiting
Facility:
Name:
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Address:
City:
Tbilisi
Zip:
0159
Country:
Georgia
Status:
Recruiting
Facility:
Name:
University Medical Center Mannheim
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Status:
Recruiting
Facility:
Name:
University Hospital Tuebingen
Address:
City:
Tubingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Facility:
Name:
University Hospital Augsburg
Address:
City:
Augsburg
Zip:
86179
Country:
Germany
Status:
Recruiting
Facility:
Name:
Hautklinik Universitatsklinikum Erlangen
Address:
City:
Erlangen
Zip:
91054
Country:
Germany
Status:
Recruiting
Facility:
Name:
LMU Klinikum Munchen, Pharmacy
Address:
City:
Munchen
Zip:
80337
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Darmstadt GmbH
Address:
City:
Darmstadt
Zip:
64283
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitatsmedizin Gottingen
Address:
City:
Gottingen
Zip:
37075
Country:
Germany
Status:
Recruiting
Facility:
Name:
Helios Kliniken Schwerin GmbH, Apotheke
Address:
City:
Schwerin
Zip:
19055
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetstklinikum Muenster Central Study Coordination for innovative Dermatology (ZID)
Address:
City:
Muenster
Zip:
48149
Country:
Germany
Status:
Recruiting
Facility:
Name:
Hohenzollernapotheke
Address:
City:
Muenster
Zip:
48157
Country:
Germany
Status:
Suspended
Facility:
Name:
Klinikum der Stadt Ludwigshafen am Rhein
Address:
City:
Ludwigshafen
Zip:
67063
Country:
Germany
Status:
Recruiting
Facility:
Name:
Harzklinikum Dorothea Christiane Erxleben GmbH, Zentrale Krankenhausapotheke
Address:
City:
Quedlinburg
Zip:
06484
Country:
Germany
Status:
Recruiting
Facility:
Name:
University Hospital Carl Gustav Carus
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Facility:
Name:
UKSH-Campus Kiel
Address:
City:
Kiel
Zip:
24105
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Schleswig-Holstein Campus Lubeck
Address:
City:
Luebeck
Zip:
23538
Country:
Germany
Status:
Recruiting
Facility:
Name:
Campus Virchow Klinikum, Apotheke Zytostatika Studien, Charite - Universitatsmedizin Berlin,
Address:
City:
Berlin
Zip:
10117
Country:
Germany
Status:
Recruiting
Facility:
Name:
Katholisches Klinikum Bochum -Zentral Apotheke
Address:
City:
Bochum
Zip:
44791
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Bremen-Ost - Studienambulanz Dermatologie
Address:
City:
Bremen
Zip:
28325
Country:
Germany
Status:
Recruiting
Facility:
Name:
Helios Klinikum Erfurt
Address:
City:
Erfurt
Zip:
99089
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Essen, Apotheke
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitatsklinikum Regensburg Studienburo Dermatologie
Address:
City:
Regensburg
Zip:
93053
Country:
Germany
Status:
Recruiting
Facility:
Name:
A Oncology Dpt, Laiko General Hospital of Athens
Address:
City:
Goudi
Zip:
11527
Country:
Greece
Status:
Recruiting
Facility:
Name:
A Oncology Dpt, Metropolitan Hospital
Address:
City:
Athens
Zip:
18547
Country:
Greece
Status:
Recruiting
Facility:
Name:
Bioclinic of Thessaloniki
Address:
City:
Thessaloniki
Zip:
54622
Country:
Greece
Status:
Recruiting
Facility:
Name:
Iatriko Diavalkaniko Thessaloniki, Pharmacy
Address:
City:
Thessaloniki
Zip:
57001
Country:
Greece
Status:
Recruiting
Facility:
Name:
Theagenio Cancer Center
Address:
City:
Efkarpia
Zip:
56403
Country:
Greece
Status:
Recruiting
Facility:
Name:
University Hospital Galway
Address:
City:
Galway
Zip:
H91 YR71
Country:
Ireland
Status:
Recruiting
Facility:
Name:
Beaumont Hospital
Address:
City:
Beaumont
Zip:
D09V2N0
Country:
Ireland
Status:
Recruiting
Facility:
Name:
University College Cork-Cork University Maternity Hospital
Address:
City:
Cork
Country:
Ireland
Status:
Recruiting
Facility:
Name:
St Vincent's University Hospital
Address:
City:
Dublin
Zip:
D04 T6F4
Country:
Ireland
Status:
Recruiting
Facility:
Name:
Haemek Medical Center
Address:
City:
Afula
Zip:
1834111
Country:
Israel
Status:
Recruiting
Facility:
Name:
The Chaim Sheba Medical Center
Address:
City:
Ramat-Gan
Zip:
52621
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah Ein Kerem Medical Center
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Facility:
Name:
UOC del Farmaco - PO San Salvatore
Address:
City:
L'Aquila
Zip:
67100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Universita della Campania Luigi Vanvitella
Address:
City:
Napoli
Zip:
80121
Country:
Italy
Status:
Recruiting
Facility:
Name:
Instituto Nazionale Tumori IRCCS Fondazione G. Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Clinica Malattie Infettive, Azienda Ospedaliero Universitaria
Address:
City:
Udine
Zip:
33100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Fondazione Policlinico Campus Bio-Medico
Address:
City:
Rome
Zip:
00128
Country:
Italy
Status:
Recruiting
Facility:
Name:
Farmacia Ospedaliera, Fondazione Policlinico Universitario Agostini Gemeli IRCCS
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Facility:
Name:
Farmacia Ospedaliera, Instituto Europeo di Oncologia
Address:
City:
Milan
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Clinico Humanitas FARMACIA
Address:
City:
Rozzano
Zip:
23538
Country:
Italy
Status:
Recruiting
Facility:
Name:
AO S.Croce E Carle
Address:
City:
Cuneo
Zip:
12100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)
Address:
City:
Roma
Zip:
00167
Country:
Italy
Status:
Recruiting
Facility:
Name:
AO perugia SC Oncologia
Address:
City:
Perugia
Zip:
06132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Arcispedale SantAnna UOC Farmacia Ospedaliera Ufficio sperimentazioni cliniche, SETTORE 2B1 Presidi
Address:
City:
Cona
Zip:
44124
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero Universitaria Maggiore della Carita, Farmacia Ospedaliera
Address:
City:
Novara
Zip:
28100
Country:
Italy
Status:
Recruiting
Facility:
Name:
UOC Oncologia Medica
Address:
City:
Taormina
Zip:
98039
Country:
Italy
Status:
Recruiting
Facility:
Name:
Farmacia Ospedaliera - Azienda Ospedaliero Universitaria delle Marche
Address:
City:
Torrette
Zip:
60126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale S.Chiara - APSS di Trento - Magazzino Farmacia
Address:
City:
Trento
Zip:
38123
Country:
Italy
Status:
Recruiting
Facility:
Name:
Preparaciones Oncologicas S. C.
Address:
City:
Leon Guanajuato
Zip:
37178
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Hospital Civil de Guadalajara Fray Antonio Alcalde
Address:
City:
Guadalajara
Zip:
44280
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Investigacion Biomedica para el Desarrollo de Farmacos S.A de C.V
Address:
City:
Zapopan
Zip:
45070
Country:
Mexico
Status:
Recruiting
Facility:
Name:
iCan Oncology Center S.A de C.V.
Address:
City:
Monterrey
Zip:
64710
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Neurociencias Estudios Clinicos S. C.
Address:
City:
Culiacan
Zip:
80020
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Centro de Atencion e Investigacion Clinica en Oncologia
Address:
City:
Merida
Zip:
97134
Country:
Mexico
Status:
Recruiting
Facility:
Name:
FAICIC S. de R.L. de C.V.
Address:
City:
Veracruz
Zip:
91900
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
Address:
City:
Siedlce
Zip:
08-110
Country:
Poland
Status:
Recruiting
Facility:
Name:
Uniwersyteckie Centrum Kliniczne (UCK)
Address:
City:
Gdansk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Facility:
Name:
Wojewodzkie Centrum Onkologii w Gdansku Sp. zo.o.
Address:
City:
Gdansk
Zip:
80-219
Country:
Poland
Status:
Recruiting
Facility:
Name:
Wojewodzki Szpital Specjalistyczny im. J. Korczaka w Slupsku
Address:
City:
Slupsk
Zip:
16-200
Country:
Poland
Status:
Recruiting
Facility:
Name:
Centrul de Oncologie Sf. Nectarie S.R.L/SC
Address:
City:
Craiova
Zip:
200542
Country:
Romania
Status:
Recruiting
Facility:
Name:
Radiotheraoy Center Cluj/Ph
Address:
City:
Cluj
Zip:
407280
Country:
Romania
Status:
Recruiting
Facility:
Name:
Centrul De Oncologie Euroclinic
Address:
City:
Iași
Zip:
700106
Country:
Romania
Status:
Recruiting
Facility:
Name:
Oncocenter-Oncologie Clinica SRL
Address:
City:
Timisoara
Zip:
300210
Country:
Romania
Status:
Recruiting
Facility:
Name:
Oncomed
Address:
City:
Timisoara
Zip:
300239
Country:
Romania
Status:
Recruiting
Facility:
Name:
Cardiomed
Address:
City:
Cluj Napoca
Zip:
400015
Country:
Romania
Status:
Recruiting
Facility:
Name:
Institul Oncologic Prof. Dr Ion Chiricuta
Address:
City:
Cluj Napoca
Zip:
400015
Country:
Romania
Status:
Recruiting
Facility:
Name:
Institute of Oncology Bucharest
Address:
City:
Bucharest
Zip:
022328
Country:
Romania
Status:
Recruiting
Facility:
Name:
The Medical Oncology Centre of Rosebank
Address:
City:
Johannesburg
Zip:
2196
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Wilgers Oncology Center
Address:
City:
Pretoria
Zip:
7570
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Cape Gate Oncology Trials
Address:
City:
Cape Town
Zip:
7570
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Clinical Research Centre
Address:
City:
Cape town
Zip:
7925
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Central de Asturias
Address:
City:
Oviedo
Zip:
33011
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Marques De Valdecilla
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Quiron Dexeus Barcelona
Address:
City:
Barcelona
Zip:
08028
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Vall d'Hebron, Edificio General-Planta Baja, UITM, Unidad de Farmacia de Ensa
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Facility:
Name:
Institut Catala d'Oncologia
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen de las Nieves
Address:
City:
Granada
Zip:
18014
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Lucus Augusti
Address:
City:
Lugo
Zip:
27003
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Maranon (HGUGM)
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario HM Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Fundacion Instituto Valenciano de Oncologia
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Sbu Dr. A.Y. Ankara Onkoloji Suam
Address:
City:
Ankara
Zip:
06100
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Gulhane Egitim ve Arastirma Hastanesi
Address:
City:
Keçiören
Zip:
06010
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Liv Hospital
Address:
City:
Ankara
Zip:
06010
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ankara Memorial Hospital
Address:
City:
Ankara
Zip:
06520
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Adana Kisla Baskent Unv Hospital
Address:
City:
Adana
Zip:
01120
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Dicle University, Faculty of Medicine
Address:
City:
Diyarbakir
Zip:
21280
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Trakya Universitesi, Balkan Onkoloji Hastanesi Linik Arastirmar Odasi
Address:
City:
Iskender
Zip:
22130
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Medical Park Gaziantep Hastanesi
Address:
City:
Sehitkamil
Zip:
27310
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Address:
City:
Istanbul
Zip:
81450
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Istanbul Universitesi CerrahpaSa- Cerrahpasa Tip Fakultesi
Address:
City:
Fatih
Zip:
34098
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Izmir Katip Celebi University Ataturk training and Research Hospital
Address:
City:
Izmir
Zip:
35360
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Kocaeli University Hospital
Address:
City:
Umuttepe
Zip:
41380
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Royal Devon University Healthcare NHS Foundation Trust, Clinical Trials Pharmacy
Address:
City:
Exeter
Zip:
EX2 5DW
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Clinical research pharmacy
Address:
City:
Chelsea
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Pharmacy Clinical Trials, Pharmacy Department, Alexander Donald Building, Western General Hospital
Address:
City:
Edinburgh
Zip:
EH4 2LF
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Clinical Trials Unit Bristol Haematology & Oncology Centre
Address:
City:
Bristol
Zip:
BS2 8ED
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Musgrove Park Hospital, Somerset Foundation Trust
Address:
City:
Taunton
Zip:
TA1 5DA
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Pharmacy Chemotherapy Unit, St Barthomews Hospital West Smithfield
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Start date:
January 16, 2023
Completion date:
February 15, 2030
Lead sponsor:
Agency:
Regeneron Pharmaceuticals
Agency class:
Industry
Source:
Regeneron Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05608291
https://harmonyadjuvantmelanomastudy.com/
