Trial Title:
A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
NCT ID:
NCT05625399
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Nivolumab
Relatlimab
Conditions: Keywords:
Nivolumab
Relatlimab
FDC
Melanoma
rHuPH20
OPDUALAG
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:
Drug
Intervention name:
Nivolumab + Relatlimab
Description:
Specified dose on specified days
Arm group label:
Nivolumab + Relatlimab FDC IV
Arm group label:
Nivolumab + Relatlimab FDC SC
Other name:
BMS-986213
Other name:
Opdualag
Intervention type:
Drug
Intervention name:
rHuPH20
Description:
Specified dose on specified days
Arm group label:
Nivolumab + Relatlimab FDC SC
Summary:
The purpose of this study is to demonstrate that the study drug exposure level of the
nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab +
relatlimab FDC intravenous (IV) administration in participants with previously untreated
metastatic or unresectable melanoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance
status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of
age).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV
(metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging
system.
- Participants must have measurable disease by computed tomography (CT) or magnetic
resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1
(RECIST v1.1).
- Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and <
18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed
consent (assent).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV
(metastatic) melanoma, per the AJCC staging system (8th edition).
Exclusion Criteria
- Participants must not have ocular melanoma.
- Participants must not have a history of myocarditis, regardless of etiology.
- Participants must not have a condition requiring systemic treatment with either
corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other
immunosuppressive medications within 14 days of start of study treatment. Inhaled or
topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone
equivalent, are permitted in the absence of active autoimmune disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dignity Health - St. Josephs Hospital and Medical Center
Address:
City:
Phoenix
Zip:
85013
Country:
United States
Status:
Recruiting
Contact:
Last name:
Miguel Gonzalez Velez, Site 0125
Facility:
Name:
Highlands Oncology Group (HOG) - Fayetteville - North Hills Location
Address:
City:
Springdale
Zip:
72762
Country:
United States
Status:
Recruiting
Contact:
Last name:
J. Thaddeus Beck, Site 0189
Phone:
479-936-9900
Facility:
Name:
The Angeles Clinic and Research Institute
Address:
City:
Los Angeles
Zip:
90025
Country:
United States
Status:
Recruiting
Contact:
Last name:
Inderjit Mehmi, Site 0098
Phone:
310-231-2153
Facility:
Name:
UC Irvine Health
Address:
City:
Orange
Zip:
92868-3201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Warren Chow, Site 0093
Phone:
714-456-3905
Facility:
Name:
Stanford Univ Med School Dept of Dermatology
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sunil Reddy, Site 0123
Phone:
650-743-4516
Facility:
Name:
The Melanoma and Skin Cancer Institute
Address:
City:
Englewood
Zip:
80113
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ryan Weight, Site 0113
Facility:
Name:
Mayo Clinic - Jacksonville
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Roxana Dronca, Site 0114
Phone:
507-284-2511
Facility:
Name:
Ft. Wayne Medical Oncology and Hematology
Address:
City:
Fort Wayne
Zip:
46804
Country:
United States
Status:
Withdrawn
Facility:
Name:
Greenebaum Cancer Center University of Maryland
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Peter Hausner, Site 0146
Phone:
301-980-6676
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Svetomir Markovic, Site 0071
Phone:
507-284-2511
Facility:
Name:
Oncology Hematology West P.C. Nebraska Cancer Specialist
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ralph Hauke, Site 0013
Phone:
402-334-4773
Facility:
Name:
Rutgers CINJ
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Withdrawn
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Isaacs, Site 0169
Phone:
216444-8665
Facility:
Name:
St. Lukes University Health Network
Address:
City:
Easton
Zip:
18045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melissa Wilson, Site 0139
Phone:
212-731-6160
Facility:
Name:
Thomas Jefferson University Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rino Seedor, Site 0124
Phone:
215-955-9980
Facility:
Name:
Intermountain Medical Center Campus Location
Address:
City:
Murray
Zip:
84107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Caroline Nebhan, Site 0122
Facility:
Name:
Inova Health Care Services
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sekwon Jang, Site 0115
Phone:
571-472-4724
Facility:
Name:
Local Institution - 0042
Address:
City:
Caba
Zip:
1125
Country:
Argentina
Status:
Withdrawn
Facility:
Name:
Local Institution - 0067
Address:
City:
Caba
Zip:
C1187
Country:
Argentina
Status:
Not yet recruiting
Contact:
Last name:
Site 0067
Facility:
Name:
Local Institution - 0070
Address:
City:
Caba
Zip:
C1426ANZ
Country:
Argentina
Status:
Not yet recruiting
Contact:
Last name:
Site 0070
Facility:
Name:
Local Institution - 0133
Address:
City:
Ciudad Autonoma de Buenos Aires
Zip:
C1426ABP
Country:
Argentina
Status:
Not yet recruiting
Contact:
Last name:
Site 0133
Facility:
Name:
Local Institution - 0145
Address:
City:
Caba
Zip:
1430
Country:
Argentina
Status:
Withdrawn
Facility:
Name:
Local Institution - 0160
Address:
City:
Rosario
Zip:
2000
Country:
Argentina
Status:
Not yet recruiting
Contact:
Last name:
Site 0160
Facility:
Name:
Local Institution - 0023
Address:
City:
Caba
Zip:
1125
Country:
Argentina
Status:
Not yet recruiting
Contact:
Last name:
Site 0023
Facility:
Name:
Local Institution - 0057
Address:
City:
Cordoba
Zip:
5000
Country:
Argentina
Status:
Not yet recruiting
Contact:
Last name:
Site 0057
Facility:
Name:
Local Institution - 0020
Address:
City:
Tucuman
Zip:
4000
Country:
Argentina
Status:
Not yet recruiting
Contact:
Last name:
Site 0020
Facility:
Name:
North Coast Area Health Service NCAHS - The North Coast Cancer Institute NCCI - Coffs Harbour Health Campus
Address:
City:
Coffs Harbour
Zip:
2450
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Karen Briscoe, Site 0050
Phone:
61266565737
Facility:
Name:
Orange Health Service
Address:
City:
Orange
Zip:
2800
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Matteo Carlino, Site 0175
Phone:
61298455200
Facility:
Name:
Port Macquarie Base Hospital
Address:
City:
Port Macquarie
Zip:
2444
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Georgia Ritchie, Site 0172
Phone:
61265801818
Facility:
Name:
Riverina Cancer Care Centre
Address:
City:
Wagga Wagga
Zip:
2650
Country:
Australia
Status:
Recruiting
Contact:
Last name:
David Palmieri, Site 0118
Phone:
0407793592
Facility:
Name:
Calvary Mater Newcastle
Address:
City:
Waratah
Zip:
2298
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Ina Nordman, Site 0184
Phone:
61240143575
Facility:
Name:
Westmead Hospital
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Matteo Carlino, Site 0033
Phone:
61298455200
Facility:
Name:
University of Sydney - Melanoma Institute Australia MIA
Address:
City:
Wollstonecraft
Zip:
2065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Georgina Long, Site 0055
Phone:
61299117336
Facility:
Name:
Sunshine Coast University Private Hospital
Address:
City:
Birtinya
Zip:
4575
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jeremy Long, Site 0090
Phone:
0428190959
Facility:
Name:
Local Institution - 0183
Address:
City:
Woodville South
Zip:
5011
Country:
Australia
Status:
Withdrawn
Facility:
Name:
Bendigo Health - Bendigo Cancer Centre
Address:
City:
Bendigo
Zip:
3550
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Samuel Harris, Site 0008
Phone:
61354548815
Facility:
Name:
Box Hill Hospital-Eastern Health
Address:
City:
Box Hill
Zip:
3128
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Phillip Parente, Site 0059
Phone:
61398953585
Facility:
Name:
Austin Hospital - Medical Oncology Unit
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Damien Kee, Site 0154
Phone:
61385595000
Facility:
Name:
The Alfred Hospital
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Andrew Haydon, Site 0030
Phone:
61390763129
Facility:
Name:
Latrobe Regional Health
Address:
City:
Traralgon
Zip:
3844
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Quan Tran, Site 0109
Facility:
Name:
One Clinical Research
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Adnan Khattak, Site 0161
Phone:
61861526726
Facility:
Name:
Sir Charles Gairdner Hospital
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Andrisha Inderjeeth, Site 0106
Phone:
610861526537
Facility:
Name:
Local Institution - 0027
Address:
City:
Graz
Zip:
8036
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Site 0027
Facility:
Name:
Universitatsklinik fur Dermatologie der Paracelsus medizinischen Privatuniversitat Salzburg
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Peter Koelblinger, Site 0029
Phone:
435725557842
Facility:
Name:
Department of Dermatology, University Hospital St. Poelten
Address:
City:
St. Polten
Zip:
3100
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Christine Hafner, Site 0168
Phone:
+432742900411091
Facility:
Name:
Medizinische Universitaet WienAKH, Dpt. of Dermatology
Address:
City:
Wien
Zip:
1090
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Christoph Hoeller, Site 0037
Phone:
+4314040077310
Facility:
Name:
Cliniques Universitaires Saint Luc
Address:
City:
Brussels
Zip:
1200
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Jean-Francois Baurain, Site 0072
Facility:
Name:
Grand Hôpital de Charleroi-Oncology & Hematology
Address:
City:
Charleroi
Zip:
6000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Christophe Lonchay, Site 0078
Phone:
+32 71 10 47 33
Facility:
Name:
Local Institution - 0036
Address:
City:
Jette
Zip:
1090
Country:
Belgium
Status:
Withdrawn
Facility:
Name:
CHU de Liege
Address:
City:
Liege
Zip:
4000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Andree Rorive, Site 0016
Phone:
003243237801
Facility:
Name:
Local Institution - 0179
Address:
City:
Salvador
Zip:
40170-110
Country:
Brazil
Status:
Withdrawn
Facility:
Name:
Instituto de Ensino e Pesquisa Oncocentro
Address:
City:
Fortaleza
Zip:
60135237
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Fabio Nasser dos Santos, Site 0177
Phone:
5585981846767
Facility:
Name:
Hospital Santa Rita de Cassia (Vitoria/ES)
Address:
City:
Vitoria
Zip:
29043-260
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Glaucio Bertollo, Site 0180
Phone:
552733348000
Facility:
Name:
Oncologia de Preciso e Personalizada
Address:
City:
Belo Horizonte
Zip:
30130-090
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Alberto Julius Alves Wainstein, Site 0107
Phone:
553130474652
Facility:
Name:
Local Institution - 0147
Address:
City:
Curitiba
Zip:
80520-174
Country:
Brazil
Status:
Withdrawn
Facility:
Name:
ONCOSITE -Centro de Pesquisa Clinica em Oncologia Ltda
Address:
City:
Ijui
Zip:
98700-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Fabio Franke, Site 0025
Phone:
+5555991592101
Facility:
Name:
Hospital Nossa Senhora Da Conceicao
Address:
City:
Porto Alegrelegre
Zip:
91350-250
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Juliana Janoski de Menezes, Site 0002
Phone:
+555133572092+555132
Facility:
Name:
UPCO - Hospital de Clinicas de Porto Alegre
Address:
City:
Porto Alegre
Zip:
90035-903
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Sergio De Azevedo, Site 0031
Phone:
555133598619
Facility:
Name:
Hosptial Sao Lucas da PUC de Porto Alegre
Address:
City:
Porto Alegre
Zip:
90610-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Fernanda Damian, Site 0058
Phone:
555133203039
Facility:
Name:
Local Institution - 0132
Address:
City:
Florianopolis
Zip:
88034-000
Country:
Brazil
Status:
Withdrawn
Facility:
Name:
Local Institution - 0182
Address:
City:
Lages
Zip:
55801-001
Country:
Brazil
Status:
Withdrawn
Facility:
Name:
Hospital do Amor de Barretos
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Fernanda Hassan, Site 0009
Phone:
551733216637
Facility:
Name:
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
Address:
City:
Sao Jose do Rio Preto
Zip:
15090-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Joao Daniel Cardoso Guedes, Site 0018
Phone:
551732015054
Facility:
Name:
Clinica de Oncologia Reichow
Address:
City:
Blumenau
Zip:
89010-340
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Sandro Reichow, Site 0159
Phone:
554733805890
Facility:
Name:
INCA- Instituto Nacional de Cancer Jose de Alencar Gomes da Silva
Address:
City:
Rio De Janeiro
Zip:
20220-410
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Andreia De Melo, Site 0110
Phone:
552132076507
Facility:
Name:
Instituto COI
Address:
City:
Sao Paulo
Zip:
01321-001
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Bruna Bighetti, Site 0130
Phone:
+5511976801824
Facility:
Name:
Tom Baker Cancer Centre (TBCC) - Alberta Health Services (AHS)
Address:
City:
Calgary
Zip:
T2N 4N2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Jose Monzon, Site 0141
Phone:
5878967323
Facility:
Name:
Juravinski Cancer Centre
Address:
City:
Hamilton
Zip:
L8V 5C2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Elaine Mcwhirter, Site 0121
Phone:
19053879495
Facility:
Name:
Ottawa Hospital Research Institute
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Xinni Song, Site 0096
Phone:
6137377700ext70208
Facility:
Name:
Sunnybrook Health Sciences Centre
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Teresa Petrella, Site 0116
Phone:
4164805248
Facility:
Name:
Hopital de l Enfant Jesus
Address:
City:
Quebec
Zip:
G1J 1Z4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Felix Couture, Site 0103
Phone:
4186915225
Facility:
Name:
Sociedad de Investigacion Medica Limitada
Address:
City:
Temuco
Zip:
4800827
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Patricio Yanez Weber, Site 0143
Phone:
+56994443272
Facility:
Name:
Patagonia Research
Address:
City:
Puerto Montt
Zip:
5507642
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Claudio Painemal, Site 0178
Phone:
56998634501
Facility:
Name:
Bradford Hill Centro de Investigacion Clnica
Address:
City:
Recoleta
Zip:
8380455
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Carlos Rojas Garcia, Site 0140
Phone:
56229490970
Facility:
Name:
Clinica San Carlos de Apoquindo
Address:
City:
Santiago
Zip:
0101010
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Sebastian Mondaca, Site 0144
Facility:
Name:
Local Institution - 0010
Address:
City:
Santiago
Zip:
7510032
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Site 0010
Facility:
Name:
Clinica Vespucio
Address:
City:
Santiago
Zip:
8150513
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Paola Celedon, Site 0074
Phone:
56232100060
Facility:
Name:
Local Institution - 0142
Address:
City:
Vitacura
Zip:
JC5G 2Q
Country:
Chile
Status:
Withdrawn
Facility:
Name:
Centro de Estudios Clinicos SAGA SpA
Address:
City:
Santiago de Chile
Zip:
7500653
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Marcelo Garrido, Site 0119
Phone:
+56991612199
Facility:
Name:
Oncocentro Apys
Address:
City:
Vina Del Mar
Zip:
2520598
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Alenjandro Andres Acevedo Gaete, Site 0028
Phone:
5632332059
Facility:
Name:
Local Institution - 0176
Address:
City:
Via Del Mar
Zip:
254-0488
Country:
Chile
Status:
Withdrawn
Facility:
Name:
Fundacion Arturo Lopez Perez
Address:
City:
Santiago
Zip:
7500921
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Christian Caglevic, Site 0017
Phone:
56224457254
Facility:
Name:
Local Institution - 0152
Address:
City:
Bogota
Zip:
111511
Country:
Colombia
Status:
Withdrawn
Facility:
Name:
Local Institution - 0149
Address:
City:
Medellin
Zip:
50030
Country:
Colombia
Status:
Withdrawn
Facility:
Name:
Local Institution - 0150
Address:
City:
Valledupar
Zip:
200005
Country:
Colombia
Status:
Withdrawn
Facility:
Name:
Univerzita Karlova v Praze a Vseobecna fakultni nemocnice v Praze
Address:
City:
Prague
Zip:
128 00
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Ivana Krajsova, Site 0083
Phone:
+420224962426
Facility:
Name:
University Hospital Hradec Kralove
Address:
City:
Hradec Kralove
Zip:
500 05
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Jindrich Kopecky, Site 0094
Phone:
+420495832176
Facility:
Name:
Fakultni nemocnice Olomouc FNOL
Address:
City:
Olomouc
Zip:
77900
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Bohuslav Melichar, Site 0091
Phone:
420588444295
Facility:
Name:
FN Ostrava
Address:
City:
Ostrava Poruba
Zip:
708 52
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Yvetta Vantuchova, Site 0082
Phone:
00420597374573
Facility:
Name:
Fakultni Nemocnice Kralovske Vinohrady FNKV
Address:
City:
Prague
Zip:
182 00
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Monika Arenbergerova, Site 0095
Phone:
00420602250876
Facility:
Name:
Helsinki University Hospital HUS
Address:
City:
Helsinki
Zip:
00029
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Micaela Hernberg, Site 0164
Phone:
358504279490
Facility:
Name:
Pirkanmaan Sairaanhoitopiiri - Tampereen Yliopistollinen Sairaala Tampere University Hospital - Keskussairaala
Address:
City:
Tampere
Zip:
33521
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Tanja Skytta, Site 0167
Phone:
+358331163203
Facility:
Name:
Turku University Hospital
Address:
City:
Turku
Zip:
20520
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Kalle Mattila, Site 0162
Phone:
+35823130729
Facility:
Name:
Institut Claudius Regaud IUCT O
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Last name:
Cecile Pages Laurent, Site 0108
Phone:
33531155675
Facility:
Name:
Hopital Saint-Louis
Address:
City:
Paris
Zip:
75475
Country:
France
Status:
Recruiting
Contact:
Last name:
Celeste Lebbe, Site 0034
Phone:
33142494949
Facility:
Name:
CHRU de Tours - Hopital Trousseau
Address:
City:
Chambray-les-Tours
Zip:
37044
Country:
France
Status:
Recruiting
Contact:
Last name:
Laurent Machet, Site 0127
Phone:
+33247478773
Facility:
Name:
CHU Lille - Hopital Huriez
Address:
City:
Lille
Zip:
59000
Country:
France
Status:
Recruiting
Contact:
Last name:
Laurent MORTIER, Site 0111
Phone:
33320444193
Facility:
Name:
Hotel Dieu CHU Nantes
Address:
City:
Nantes Cedex 01
Zip:
44093
Country:
France
Status:
Recruiting
Contact:
Last name:
Gaelle Quereux, Site 0063
Phone:
0240083144
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Last name:
Caroline Robert, Site 0061
Phone:
33142114210
Facility:
Name:
CHU Amiens-Picardie - Site Nord
Address:
City:
Amiens
Zip:
80054
Country:
France
Status:
Recruiting
Contact:
Last name:
Jean-Philippe Arnault, Site 0007
Phone:
33322455843
Facility:
Name:
Centre Hospitalier de la Cote Basque
Address:
City:
Bayonne
Zip:
64100
Country:
France
Status:
Recruiting
Contact:
Last name:
Suzanne Devaux, Site 0128
Phone:
330559443780
Facility:
Name:
CHU de Bordeaux - Hopital Saint-Andre
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Recruiting
Contact:
Last name:
Caroline Dutriaux, Site 0022
Phone:
33556794705
Facility:
Name:
Centre Hospitalier Universitaire de Clermont Ferrand
Address:
City:
Clermont Ferrand Cedex 1
Zip:
63003
Country:
France
Status:
Recruiting
Contact:
Last name:
Sandrine Mansard, Site 0129
Phone:
+33473750550
Facility:
Name:
CHU Dijon - Hopital Francois Mitterand
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Recruiting
Contact:
Last name:
Geraldine Jeudy, Site 0046
Phone:
33380293336
Facility:
Name:
Local Institution - 0117
Address:
City:
Marseille
Zip:
13385
Country:
France
Status:
Recruiting
Contact:
Last name:
Site 0117
Facility:
Name:
Local Institution - 0190
Address:
City:
Marseille
Zip:
13385
Country:
France
Status:
Withdrawn
Facility:
Name:
Hopital Lyon Sud
Address:
City:
Pierre-Benite
Zip:
69310
Country:
France
Status:
Recruiting
Contact:
Last name:
Stephane Dalle, Site 0052
Phone:
33478861679
Facility:
Name:
Centre Eugene Marquis
Address:
City:
Rennes Cedex
Zip:
35042
Country:
France
Status:
Recruiting
Contact:
Last name:
Marc Pracht, Site 0089
Phone:
33299253196
Facility:
Name:
CHU de Rouen - Hopital Charles Nicolle
Address:
City:
Rouen
Zip:
76031
Country:
France
Status:
Recruiting
Contact:
Last name:
Anne-Benedicte Duval Modeste, Site 0099
Phone:
+33232886841
Facility:
Name:
Local Institution - 0181
Address:
City:
Saint Etienne
Zip:
42055
Country:
France
Status:
Withdrawn
Facility:
Name:
Nationales Centrum fr Tumorerkrankungen NCT
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Jessica Hassel, Site 0101
Phone:
06221-5638503
Facility:
Name:
Universitaetsklinikum Ulm
Address:
City:
Ulm
Zip:
89081
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Anca Sindrilaru, Site 0079
Phone:
4973150057602
Facility:
Name:
Universittsklinikum Regensburg
Address:
City:
Regensburg
Zip:
93042
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Sebastian Haferkamp, Site 0011
Phone:
499419449605
Facility:
Name:
Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude
Address:
City:
Buxtehude
Zip:
21614
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Peter Mohr, Site 0038
Phone:
4941617036250
Facility:
Name:
Universitaetsklinikum Schleswig-Holstein
Address:
City:
Luebeck
Zip:
23538
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Patrick Terheyden, Site 0003
Phone:
491735479918
Facility:
Name:
Charite Universitaetsmedizin Berlin
Address:
City:
Berlin
Zip:
10117
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Thomas Eigentler, Site 0060
Phone:
+4930450518002
Facility:
Name:
Hautklinik Dortmund Gmbh
Address:
City:
Dortmund
Zip:
44137
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Svea Huening, Site 0136
Phone:
4915221891417
Facility:
Name:
Local Institution - 0039
Address:
City:
Erfurt
Zip:
99089
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Site 0039
Facility:
Name:
Universitaetsklinikum Essen, Klinik fuer Dermatologie
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Dirk Schadendorf, Site 0049
Phone:
492017232431
Facility:
Name:
Universitaetsklinikum Frankfurt Main
Address:
City:
Frankfurt
Zip:
60590
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Roland Kaufmann, Site 0166
Phone:
+00496963015311 000
Facility:
Name:
Department of Dermatology, University hospital Giessen
Address:
City:
Giessen
Zip:
35385
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Daniela Goeppner, Site 0065
Phone:
4949641985
Facility:
Name:
Local Institution - 0135
Address:
City:
Goettingen
Zip:
37075
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Site 0135
Facility:
Name:
Universitaetsklinikum Hamburg Eppendorf - UKE, Dept of Dermatology (W14)
Address:
City:
Hamburg
Zip:
20251
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christoffer Gebhardt, Site 0138
Phone:
004915222873742
Facility:
Name:
Local Institution - 0148
Address:
City:
Koeln
Zip:
50937
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Local Institution - 0137
Address:
City:
Ludwigshafen
Zip:
67063
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Site 0137
Facility:
Name:
Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Dermatologie Venerologie und Allergologie - Standort Marburg
Address:
City:
Marburg
Zip:
35043
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Martin Gschnell, Site 0165
Phone:
4964215869115
Facility:
Name:
Johannes Wesling Medical Center Minden
Address:
City:
Minden
Zip:
32429
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Ralf Gutzmer, Site 0044
Phone:
495717094501
Facility:
Name:
Local Institution - 0076
Address:
City:
Munchen
Zip:
80337
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Studienambulanz Hautklinik Klinikum Nuernberg
Address:
City:
Nuernberg
Zip:
90419
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Dirk Debus, Site 0112
Phone:
499113982044
Facility:
Name:
Unviersitaetsmedizin Rostock
Address:
City:
Rostock
Zip:
18057
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Julia Tietze, Site 0053
Phone:
+498951606325
Facility:
Name:
Studienzentrum Hautklinik Tuebingen
Address:
City:
Tuebingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Teresa Amaral, Site 0081
Phone:
+4970712984555
Facility:
Name:
Emek Medical Center
Address:
City:
Afula
Zip:
1834111
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Gil Bar-Sela, Site 0026
Phone:
97246495723
Facility:
Name:
Hadassah University Hospital
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Michal Lotem, Site 0054
Phone:
97226776781
Facility:
Name:
Rabin Medical Center
Address:
City:
Petah-Tikvah
Zip:
4941492
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Gal Markel, Site 0102
Phone:
+972-3-9378077
Facility:
Name:
Local Institution - 0035
Address:
City:
Tel Hashomer
Zip:
5262100
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Site 0035
Facility:
Name:
Tel-Aviv Sourasky Medical Center
Address:
City:
Tel-Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Mor Miodovnik, Site 0173
Phone:
9720522783911
Facility:
Name:
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Michele Guida, Site 0051
Phone:
390805555138
Facility:
Name:
IRCCS Ospedale Policlinico San Martino
Address:
City:
Genova
Zip:
16132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesco Spagnolo, Site 0077
Phone:
390105558901
Facility:
Name:
Fondazione IRCCS Istituto Nazionale Dei Tumori
Address:
City:
Milan
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Michele Del Vecchio, Site 0170
Facility:
Name:
Istituto Nazionale Tumori - Fondazione Pascale Italy
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Paolo Ascierto, Site 0084
Phone:
390815903431
Facility:
Name:
Ospedale S. Maria della Misericordia
Address:
City:
Perugia
Zip:
06132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mario Mandala, Site 0032
Phone:
39 0755287080
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giovanni Schinzari, Site 0064
Phone:
390630156318
Facility:
Name:
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Address:
City:
Siena
Zip:
53100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Michele Maio, Site 0014
Phone:
390577586335
Facility:
Name:
Local Institution - 0001
Address:
City:
Zapopan
Zip:
45070
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 0001
Facility:
Name:
Local Institution - 0104
Address:
City:
Monterrey
Zip:
64460
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 0104
Facility:
Name:
Local Institution - 0075
Address:
City:
Ciudad de Mexico
Zip:
03100
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 0075
Facility:
Name:
Local Institution - 0174
Address:
City:
Cancun
Zip:
77506
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 0174
Facility:
Name:
Local Institution - 0131
Address:
City:
Puebla
Zip:
72424
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 0131
Facility:
Name:
Local Institution - 0073
Address:
City:
Queretaro
Zip:
76000
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 0073
Facility:
Name:
Nordland hospital HF
Address:
City:
Bodo
Zip:
8005
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Bard Mannsaker, Site 0163
Phone:
47+4748122479
Facility:
Name:
Sykehuset Ostfold Kalnes
Address:
City:
Gralum
Zip:
1714
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Oyvind Tennoe, Site 0156
Phone:
4791508600
Facility:
Name:
Akershus University Hospital
Address:
City:
Lørenskog
Zip:
1474
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Martin Ruppert, Site 0158
Phone:
4767960000
Facility:
Name:
Oslo University Hospital
Address:
City:
Oslo
Zip:
0379
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Anna Winge-Main, Site 0155
Phone:
004722934000
Facility:
Name:
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Bogdan Zurawski, Site 0171
Phone:
48501446778
Facility:
Name:
Pratia MCM Krakow
Address:
City:
Krakow
Zip:
30727
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Bozena Cybulska-Stopa, Site 0021
Phone:
+48126348232
Facility:
Name:
SPZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego
Address:
City:
Opole
Zip:
45-061
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Barbara Radecka, Site 0005
Phone:
48502313767
Facility:
Name:
Poznan University of Medical Sciences
Address:
City:
Poznan
Zip:
60-780
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Jacek Mackiewicz, Site 0015
Phone:
48606228277
Facility:
Name:
Local Institution - 0187
Address:
City:
Bialystok
Zip:
15-027
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Local Institution - 0185
Address:
City:
Gliwice
Zip:
44-102
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Maria Sklodowska-Curie National Research Institute of Oncology
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Piotr Rutkowski, Site 0066
Phone:
48226439375
Facility:
Name:
Local Institution - 0048
Address:
City:
Wroclaw
Zip:
53-413
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Onkologikoa Of San Sebastian
Address:
City:
Donostia
Zip:
20014
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Karmele Mujika Eizmendi, Site 0012
Phone:
34943328315
Facility:
Name:
CH Universitario de A Corunas
Address:
City:
A Coruna
Zip:
15006
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maria Quindos Varela, Site 0086
Phone:
34981178000
Facility:
Name:
Institut Catala dOncologia
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Sofia Espana Fernandez, Site 0134
Facility:
Name:
Hospital Universitario Valle de Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Eva Munoz Couselo, Site 0047
Phone:
349327460004350
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Ana Arance Fernandez, Site 0024
Phone:
34932275402
Facility:
Name:
Local Institution - 0188
Address:
City:
Granada
Zip:
18016
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Complejo Hospitalario de Jaen
Address:
City:
Jaen
Zip:
23007
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Pedro Lopez Leiva, Site 0153
Phone:
3434+34955018000
Facility:
Name:
Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria
Address:
City:
Las Palmas de Gran Canaria
Zip:
35016
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Delvys Rodriguez Abreu, Site 0045
Phone:
3434928441738
Facility:
Name:
Hospital General Universitario Gregorio Maranon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Ivan Marquez Rodas, Site 0040
Phone:
34914269394
Facility:
Name:
Local Institution - 0126
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 0126
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Guillermo De Velasco Oria de Rueda, Site 0004
Facility:
Name:
Hospital Universitario HM Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Juan Francisco Rodriguez Moreno, Site 0056
Phone:
+34917567984
Facility:
Name:
Hospital Universitario Virgen Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Luis de la Cruz Merino, Site 0006
Phone:
34600162731
Facility:
Name:
Fundacin Instituto Valenciano de Oncologa
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maria Jose Juan-Fita, Site 0041
Phone:
34961114000
Facility:
Name:
Hospital Universitario La Fe Hospital La Fe Campanar
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Roberto Pedro Diaz Beveridge, Site 0043
Phone:
34961244193
Facility:
Name:
Hospital General Universitario de Valencia
Address:
City:
Valencia
Zip:
46014
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Alfonso Berrocal Jaime, Site 0151
Phone:
34963131800437635
Facility:
Name:
Local Institution - 0186
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Karolinska Universitetssjukhuset - Solna
Address:
City:
Solna
Zip:
171 64
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Hildur Helgadottir, Site 0062
Phone:
460851770000
Facility:
Name:
Local Institution - 0157
Address:
City:
Linkoeping
Zip:
58185
Country:
Sweden
Status:
Withdrawn
Facility:
Name:
Skne University Hospital Lund
Address:
City:
Lund
Zip:
222 42
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Bjorn Batshake, Site 0097
Phone:
46707666001
Facility:
Name:
Local Institution - 0069
Address:
City:
Uppsala
Zip:
751 85
Country:
Sweden
Status:
Withdrawn
Facility:
Name:
Inselspital Bern
Address:
City:
Bern
Zip:
3010
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Berna Oezdemir, Site 0092
Phone:
41316324114
Facility:
Name:
Kantonsspital Graubuenden
Address:
City:
Chur
Zip:
7000
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Roger Von Moos, Site 0080
Phone:
41812566647
Facility:
Name:
UNIL-CHUV Lausanne
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Sofiya Latifyan, Site 0105
Phone:
41795562698
Facility:
Name:
Local Institution - 0085
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Status:
Withdrawn
Facility:
Name:
The Royal Marsden NHS Foundation Trust
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
James Larkin, Site 0088
Phone:
442078082132
Facility:
Name:
Oxford University Hospitals NHS Foundation Trust
Address:
City:
Headington, Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Miranda Payne, Site 0068
Facility:
Name:
Local Institution - 0087
Address:
City:
Glasgow
Zip:
G12 0YN
Country:
United Kingdom
Status:
Withdrawn
Facility:
Name:
Northern Centre for Cancer Care
Address:
City:
Newcastle Upon Tyne
Zip:
NE7 7DN
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Elizabeth Plummer, Site 0120
Phone:
441912138476
Start date:
March 6, 2023
Completion date:
February 28, 2025
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05625399
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT05625399.html
