Clinical trial NCT06561386: A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%
Official title: A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: Non-squamous
PDL-1 ≥ 1%
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-08-20
Enrollment: 1000
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: The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%


Eligibility criteria: Inclusion Criteria

* Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.
* Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization.
* Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria.
* Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening.
* Participants must have a life expectancy of at least 3 months at the time of randomization.

Exclusion Criteria

* Participants must not be pregnant and/or breastfeeding.
* Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded.
* Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible.
* Participants must not have untreated central nervous system (CNS) metastases.
* Participants must not have leptomeningeal metastases (carcinomatous meningitis).
* Participants must not have concurrent malignancy requiring treatment.
* Participants must not have an active autoimmune disease.
* Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management.
* Participants must not have a history of myocarditis.
* Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Overall survival (OS) in randomized participants with PD-L1 1% to 49%
timeFrame: Up to 5 years
Secondary outcomes:
measure: OS in randomized participants with PD-L1 ≥ 1%
timeFrame: Up to 5 years
measure: Progression-free survival (PFS) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
timeFrame: Up to 5 years
measure: Overall response rate (ORR)
timeFrame: Up to 5 years
measure: Duration of response (DoR)
timeFrame: Up to 5 years
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 2.5 years
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 2.5 years
measure: Number of participants with immune-mediated adverse events (IMAEs)
timeFrame: Up to 2.5 years
measure: The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Local Institution - 0368
state: Arizona
city: Los Angeles
country: United States
facility: Local Institution - 0112
state: California
city: Sacramento
country: United States
facility: Local Institution - 0304
state: California
city: San Francisco
country: United States
facility: San Francisco Oncology Associates
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology/Oncology - Santa Monica
state: California
city: Miami
country: United States
facility: University of Miami Hospital and Clinics, Sylvester Cancer Center
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Hospital West
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - East
state: Florida
city: Chicago Ridge
country: United States
facility: Affiliated Oncologists, LLC
state: Illinois
city: Edgewood
country: United States
facility: Saint Elizabeth Medical Center Edgewood
state: Kentucky
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology
state: Mississippi
city: Bozeman
country: United States
facility: Bozeman Health Deaconess Hospital
state: Montana
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Paterson
country: United States
facility: St. Joseph's Regional Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico VA Healthcare System
state: New Mexico
city: Bronx
country: United States
facility: Local Institution - 0357
state: New York
city: Hawthorne
country: United States
facility: Local Institution - 0356
state: New York
city: New York
country: United States
facility: Local Institution - 0392
state: New York
city: Northport
country: United States
facility: Local Institution - 0380
state: New York
city: Rochester
country: United States
facility: Local Institution - 0325
state: New York
city: Syracuse
country: United States
facility: Local Institution - 0324
state: New York
city: Asheville
country: United States
facility: Messino Cancer Centers
state: North Carolina
city: Greenville
country: United States
facility: Local Institution - 0351
state: North Carolina
city: Canton
country: United States
facility: Local Institution - 0369
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Louis Stokes Cleveland VA Medical Center
state: Ohio
city: Massillon
country: United States
facility: Local Institution - 0366
state: Ohio
city: Lancaster
country: United States
facility: Lancaster General Hospital - Ann B Barshinger Cancer Institute
state: Pennsylvania
city: Abilene
country: United States
facility: Texas Oncology - West Texas
state: Texas
city: Harlingen
country: United States
facility: Local Institution - 0305
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Local Institution - 0302
state: Utah
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0379
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming
state: Buenos Aires
city: ABB
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Ciudad Autónoma De Buenos Aires
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto
state: Córdoba
city: Rosario
country: Argentina
facility: Sanatorio Parque
state: Santa Fe
city: Córdoba
country: Argentina
facility: Hospital Privado Universitario de Córdoba
city: Córdoba
country: Argentina
facility: Local Institution - 0370
city: Mar del Plata
country: Argentina
facility: Hospital Privado de Comunidad
city: Gosford
country: Australia
facility: Gosford Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: GenesisCare North Shore
state: New South Wales
city: Brisbane
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Gallipoli Medical Research Ltd
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Local Institution - 0057
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Murdoch
country: Australia
facility: St. John of God Murdoch Hospital
state: Western Australia
city: Krems
country: Austria
facility: Local Institution - 0314
state: Niederösterreich
city: Wels
country: Austria
facility: Local Institution - 0292
state: Oberösterreich
city: Wien
country: Austria
facility: Local Institution - 0293
city: Edegem
country: Belgium
facility: Local Institution - 0396
state: Antwerpen
city: Brussels
country: Belgium
facility: Local Institution - 0039
state: Bruxelles-Capitale, Région De
city: Hasselt
country: Belgium
facility: Local Institution - 0187
state: Limburg
city: Yvoir
country: Belgium
facility: Local Institution - 0038
state: Namur
city: Roeselare
country: Belgium
facility: Local Institution - 0041
state: West-Vlaanderen
city: Liège
country: Belgium
facility: Local Institution - 0185
city: Fortaleza
country: Brazil
facility: Pronutrir
state: Ceará
city: Belo Horizonte
country: Brazil
facility: Cetus Oncologia - Unidade Belo Horizonte
state: Minas Gerais
city: Belem
country: Brazil
facility: Local Institution - 0375
state: Pará
city: Natal
country: Brazil
facility: Local Institution - 0151
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Itajaí
country: Brazil
facility: Clínica de Neoplasias Litoral
state: Santa Catarina
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
state: São Paulo
city: Bauru
country: Brazil
facility: NAIC - Instituto do Câncer
state: São Paulo
city: São Caetano do Sul
country: Brazil
facility: Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer - INCA
city: São Paulo
country: Brazil
facility: Icesp - Instituto Do Câncer Do Estado de São Paulo
city: Santiago
country: Chile
facility: Orlandi Oncologia
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez (FALP)
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Bradfordhill
state: Región Metropolitana De Santiago
city: Viña del Mar
country: Chile
facility: Oncocentro Apys
state: Valparaíso
city: Hefei
country: China
facility: Local Institution - 0182
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Wanzhou
country: China
facility: Chongqing Three Gorges Central Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Local Institution - 0307
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Central People's Hospital
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Xinxiang
country: China
facility: Local Institution - 0420
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou Universtiy
state: Henan
city: Wuhan
country: China
facility: Local Institution - 0235
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Huai'an
country: China
facility: First Huai'an Hospital Affiliated to Nanjing Medical University
state: Jiangsu
city: Nanchang
country: China
facility: Local Institution - 0451
state: Jiangxi
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Xi'an
country: China
facility: Xi'an International Medical Center Hospital
state: Shaanxi
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital,Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: Local Institution - 0435
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Cancer hospital
state: Sichuan
city: Neijiang
country: China
facility: The Second People's Hospital of Neijiang
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The first Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Medellín
country: Colombia
facility: Local Institution - 0415
state: Antioquia
city: Valledupar
country: Colombia
facility: Local Institution - 0417
state: Cesar
city: Bogotá
country: Colombia
facility: Local Institution - 0443
state: Distrito Capital De Bogotá
city: Bogotá
country: Colombia
facility: Local Institution - 0418
state: Distrito Capital De Bogotá
city: Pereira
country: Colombia
facility: Local Institution - 0416
state: Risaralda
city: Cali
country: Colombia
facility: Local Institution - 0442
state: Valle Del Cauca
city: Aarhus
country: Denmark
facility: Local Institution - 0198
state: Midtjylland
city: Soenderborg
country: Denmark
facility: Local Institution - 0124
state: Syddanmark
city: Copenhagen
country: Denmark
facility: Local Institution - 0125
city: Toulouse
country: France
facility: Local Institution - 0090
state: Haute-Garonne
city: Montpellier
country: France
facility: Local Institution - 0092
state: Hérault
city: Rennes
country: France
facility: Local Institution - 0093
state: Ille-et-Vilaine
city: Vandoeuvre lès Nancy
country: France
facility: Local Institution - 0395
state: Meurthe-et-Moselle
city: Lille
country: France
facility: Local Institution - 0096
state: Nord-Pas-de-Calais
city: Toulon
country: France
facility: Local Institution - 0091
state: Provence-Alpes-Côte-d'Azur
city: Pierre-Bénite
country: France
facility: Local Institution - 0157
state: Rhône
city: Bayonne
country: France
facility: Local Institution - 0421
city: Marseille
country: France
facility: Local Institution - 0158
city: Paris
country: France
facility: Local Institution - 0089
city: Paris
country: France
facility: Local Institution - 0095
city: Esslingen
country: Germany
facility: Local Institution - 0284
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Local Institution - 0439
state: Baden-Württemberg
city: Kempten
country: Germany
facility: Local Institution - 0287
state: Bayern
city: München
country: Germany
facility: Local Institution - 0347
state: Bayern
city: Marburg
country: Germany
facility: Local Institution - 0313
state: Hessen
city: Hannover
country: Germany
facility: Local Institution - 0436
state: Niedersachsen
city: Herne
country: Germany
facility: Local Institution - 0397
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Local Institution - 0438
state: Nordrhein-Westfalen
city: Chemnitz
country: Germany
facility: Local Institution - 0437
state: Sachsen
city: Grosshansdorf
country: Germany
facility: Local Institution - 0316
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Local Institution - 0285
city: Bonn
country: Germany
facility: Local Institution - 0282
city: Essen
country: Germany
facility: Local Institution - 0288
city: Gauting
country: Germany
facility: Local Institution - 0286
city: New Delhi
country: India
facility: Local Institution - 0329
state: Delhi
city: New Delhi
country: India
facility: Local Institution - 0448
state: Delhi
city: New Delhi
country: India
facility: Local Institution - 0337
state: Delhi
city: Bengaluru
country: India
facility: Local Institution - 0333
state: Karnataka
city: Thiruvananthapuram
country: India
facility: Local Institution - 0331
state: Kerala
city: Mumbai
country: India
facility: Local Institution - 0446
state: Maharashtra
city: Mumbai
country: India
facility: Local Institution - 0336
state: Maharashtra
city: Secunderabad
country: India
facility: Local Institution - 0453
state: Telangana
city: Howrah
country: India
facility: Local Institution - 0328
state: West Bengal
city: Dublin
country: Ireland
facility: Local Institution - 0367
city: Dublin
country: Ireland
facility: Local Institution - 0028
city: Dublin
country: Ireland
facility: Local Institution - 0029
city: Dublin
country: Ireland
facility: Local Institution - 0027
city: Ravenna
country: Italy
facility: Local Institution - 0400
state: Emilia-Romagna
city: Monza
country: Italy
facility: Local Institution - 0045
state: Lombardia
city: Naples
country: Italy
facility: Local Institution - 0046
state: Napoli
city: Naples
country: Italy
facility: Local Institution - 0049
state: Napoli
city: Bari
country: Italy
facility: Local Institution - 0043
state: Puglia
city: Rome
country: Italy
facility: Local Institution - 0250
state: Roma
city: Peschiera del Garda
country: Italy
facility: Local Institution - 0221
state: Verona
city: Ravenna
country: Italy
facility: Local Institution - 0222
city: Kashiwa
country: Japan
facility: Local Institution - 0312
state: Chiba
city: Kitakyushu
country: Japan
facility: University of Occupational and Enviromental Health
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Fukuyama-shi
country: Japan
facility: Chugoku Central Hospital
state: Hiroshima
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Yokohama
country: Japan
facility: Local Institution - 0449
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa cancer center
state: Kanagawa
city: Nankoku
country: Japan
facility: Local Institution - 0444
state: Kochi
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Osaka-sayama
country: Japan
facility: Kindai University Hospital- Osakasayama Campus
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Nagaizumi-cho,Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Koto
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
city: Akashi
country: Japan
facility: Hyogo Cancer Center
city: Fukushima
country: Japan
facility: Fukushima Medical University
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do [Chungbuk]
city: Namdong-gu
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Incheon-gwangyeoksi [Incheon]
city: Hwasun
country: Korea, Republic of
facility: Local Institution - 0458
state: Jeonranamdo
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Kyǒnggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution - 0450
state: Kyǒnggi-do
city: Busan
country: Korea, Republic of
facility: Local Institution - 0454
state: Pusan-Kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Guadalajara
country: Mexico
facility: Local Institution - 0170
state: Jalisco
city: Santiago de Queretaro
country: Mexico
facility: Local Institution - 0168
state: Querétaro
city: Mexico
country: Mexico
facility: Local Institution - 0172
city: San Luis Potosí
country: Mexico
facility: Local Institution - 0169
city: Harderwijk
country: Netherlands
facility: Local Institution - 0030
state: Gelderland
city: Heerlen
country: Netherlands
facility: Local Institution - 0193
state: Limburg
city: Den Bosch
country: Netherlands
facility: Local Institution - 0196
state: Noord-Brabant
city: Zwolle
country: Netherlands
facility: Local Institution - 0195
state: Overijssel
city: Leiden
country: Netherlands
facility: Local Institution - 0036
state: Zuid-Holland
city: The Hague
country: Netherlands
facility: Local Institution - 0315
state: Zuid-Holland
city: Arnhem
country: Netherlands
facility: Local Institution - 0033
city: Groningen
country: Netherlands
facility: Local Institution - 0032
city: Tauranga
country: New Zealand
facility: Local Institution - 0407
state: Bay Of Plenty
city: Tauranga
country: New Zealand
facility: Local Institution - 0447
state: Bay Of Plenty
city: Auckland
country: New Zealand
facility: Local Institution - 0405
city: Dunedin
country: New Zealand
facility: Local Institution - 0425
city: Wellington
country: New Zealand
facility: Local Institution - 0406
city: Warsaw
country: Poland
facility: Local Institution - 0259
state: Mazowieckie
city: Prabuty
country: Poland
facility: Local Institution - 0258
state: Pomorskie
city: Konin
country: Poland
facility: Local Institution - 0255
state: Wielkopolskie
city: Poznan
country: Poland
facility: Local Institution - 0261
state: Wielkopolskie
city: Poznań
country: Poland
facility: Local Institution - 0256
state: Wielkopolskie
city: Koszalin
country: Poland
facility: Local Institution - 0257
state: Zachodniopomorskie
city: Bydgoszcz
country: Poland
facility: Local Institution - 0260
city: Łódź
country: Poland
facility: Local Institution - 0254
state: Łódzkie
city: Lisbon
country: Portugal
facility: Local Institution - 0402
state: Lisboa
city: Coimbra
country: Portugal
facility: Local Institution - 0404
city: Porto
country: Portugal
facility: Local Institution - 0403
city: Porto
country: Portugal
facility: Local Institution - 0401
city: Bucharest
country: Romania
facility: Local Institution - 0296
state: București
city: Bucharest
country: Romania
facility: Local Institution - 0298
state: București
city: Florești
country: Romania
facility: Local Institution - 0299
state: Cluj
city: Craiova
country: Romania
facility: Local Institution - 0295
state: Dolj
city: Ploiești
country: Romania
facility: Local Institution - 0297
state: Prahova
city: Cluj
country: Romania
facility: Local Institution - 0301
city: Iași
country: Romania
facility: Local Institution - 0300
city: Riyadh
country: Saudi Arabia
facility: Local Institution - 0408
state: Ar Riyāḑ
city: Dammam
country: Saudi Arabia
facility: Local Institution - 0440
state: Ash Sharqīyah
city: Jeddah
country: Saudi Arabia
facility: Local Institution - 0409
state: Makkah Al Mukarramah
city: Johannesburg
country: South Africa
facility: Local Institution - 0429
state: GP
city: Pretoria
country: South Africa
facility: Local Institution - 0432
state: GP
city: Sandton
country: South Africa
facility: Local Institution - 0427
state: GP
city: Soweto
country: South Africa
facility: Local Institution - 0431
state: GP
city: Cape Town
country: South Africa
facility: Local Institution - 0428
state: Western Cape
city: A Coruña
country: Spain
facility: Local Institution - 0270
state: A Coruña [La Coruña]
city: Barcelona
country: Spain
facility: Local Institution - 0264
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Local Institution - 0434
state: Catalunya [Cataluña]
city: L'Hospitalet de Llobregat
country: Spain
facility: Local Institution - 0267
state: Catalunya [Cataluña]
city: Palma
country: Spain
facility: Local Institution - 0414
state: Illes Balears [Islas Baleares]
city: Madrid
country: Spain
facility: Local Institution - 0413
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Local Institution - 0265
state: Madrid, Comunidad De
city: Majadahonda
country: Spain
facility: Local Institution - 0426
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Local Institution - 0411
state: València
city: Málaga
country: Spain
facility: Local Institution - 0266
city: Sevilla
country: Spain
facility: Local Institution - 0268
city: València
country: Spain
facility: Local Institution - 0269
city: Bellinzona
country: Switzerland
facility: Local Institution - 0341
state: Ticino
city: Lausanne
country: Switzerland
facility: Local Institution - 0291
state: Vaud
city: Basel
country: Switzerland
facility: Local Institution - 0290
city: Münsterlingen
country: Switzerland
facility: Local Institution - 0398
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Local Institution - 0445
state: Kaohsiung
city: New Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Adana
country: Turkey
facility: Local Institution - 0361
city: Adana
country: Turkey
facility: Local Institution - 0365
city: Ankara
country: Turkey
facility: Local Institution - 0383
city: Ankara
country: Turkey
facility: Local Institution - 0362
city: Istanbul
country: Turkey
facility: Local Institution - 0410
city: Istanbul
country: Turkey
facility: Local Institution - 0364
city: Exeter
country: United Kingdom
facility: Local Institution - 0441
state: Devon
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Dundee City
city: Larbert
country: United Kingdom
facility: Forth Valley Royal Hospital
state: Falkirk
city: Glasgow
country: United Kingdom
facility: Local Institution - 0189
state: Glasgow City
city: London
country: United Kingdom
facility: Local Institution - 0021
state: Kensington And Chelsea
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
state: London, City Of
city: London
country: United Kingdom
facility: Local Institution - 0001
state: London, City Of
city: Manchester
country: United Kingdom
facility: Local Institution - 0020
city: Wirral
country: United Kingdom
facility: Local Institution - 0024
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: