A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

Trial Title: A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

NCT ID: NCT04026412

Condition: Non-Small Cell Lung Cancer (NSCLC)

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Nivolumab
Ipilimumab
Durvalumab

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: nivolumab
Description: Specified dose on specified days
Arm group label: Arm A: nivolumab + CCRT + ipilimumab
Arm group label: Arm B: nivolumab + CCRT

Intervention type: Biological
Intervention name: ipilimumab
Description: Specified dose on specified days
Arm group label: Arm A: nivolumab + CCRT + ipilimumab

Intervention type: Biological
Intervention name: durvalumab
Description: Specified dose on specified days
Arm group label: Arm C: CCRT + durvalumab

Summary: The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status ≤1 - Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible. - Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease Exclusion Criteria: - Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation - Active infection requiring systemic therapy within 14 days prior to randomization - History of organ or tissue transplant that requires systemic use of immune suppressive agents - Prior thoracic radiotherapy Other protocol-defined inclusion/exclusion criteria apply

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Local Institution - 0119

Address:
City: La Jolla
Zip: 92093
Country: United States

Facility:
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City: San Francisco
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Country: United States

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Name: Local Institution - 0108

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City: Traverse City
Zip: 49684
Country: United States

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Name: Local Institution - 0053

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Zip: 45220
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Name: Local Institution - 0131

Address:
City: Cincinnati
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Address:
City: Cincinnati
Zip: 45267
Country: United States

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Address:
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Zip: 44106
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Address:
City: Cleveland
Zip: 44106
Country: United States

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City: Bryan
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Name: Local Institution - 0045

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Name: Local Institution - 0134

Address:
City: Gosford
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Facility:
Name: Local Institution - 0033

Address:
City: Kingswood
Zip: 2747
Country: Australia

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Name: Local Institution - 0029

Address:
City: Greenslopes
Zip: 4120
Country: Australia

Facility:
Name: Local Institution - 0028

Address:
City: Adelaide
Zip: 5000
Country: Australia

Facility:
Name: Local Institution - 0224

Address:
City: Ballarat Central
Zip: 3350
Country: Australia

Facility:
Name: Local Institution - 0052

Address:
City: Melbourne
Zip: 3004
Country: Australia

Facility:
Name: Local Institution

Address:
City: Melbourne
Zip: 3199
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Facility:
Name: Local Institution - 0030

Address:
City: Murdoch
Zip: 6150
Country: Australia

Facility:
Name: Local Institution - 0003

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Name: Local Institution - 0001

Address:
City: Gent
Zip: 9000
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Facility:
Name: Local Institution - 0004

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City: Liege
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Name: Local Institution - 0002

Address:
City: Yvoir
Zip: B-5530
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City: Ipatinga
Zip: 35160-158
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Name: Local Institution - 0234

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City: Ijui
Zip: 98700-000
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Name: Local Institution - 0034

Address:
City: Porto Alegre
Zip: 91350-200
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Name: Local Institution - 0037

Address:
City: Blumenau
Zip: 89010-340
Country: Brazil

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Name: Local Institution - 0036

Address:
City: Barretos
Zip: 14784-400
Country: Brazil

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Name: Local Institution - 0035

Address:
City: Rio de Janeiro
Zip: 20230-130
Country: Brazil

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Zip: K7L 2V7
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Zip: G7H 5H6
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Name: Local Institution - 0070

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City: Rimouski
Zip: G5L 5T1
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Name: Local Institution - 0092

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City: Trois-Rivieres
Zip: G8Z 3R9
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Name: Local Institution - 0126

Address:
City: Quebec
Zip: G1V 4G5
Country: Canada

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Name: Local Institution - 0041

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City: Santiago
Zip: 8420383
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Name: Local Institution - 0040

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Zip: 2520598
Country: Chile

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Name: Local Institution - 0146

Address:
City: Beijing
Zip: 100142
Country: China

Facility:
Name: Local Institution - 0149

Address:
City: Chongqing
Zip: 400030
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Name: Local Institution - 0179

Address:
City: Fuzhou
Zip: 350000
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City: Xiamen
Zip: 361003
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Name: Local Institution - 0192

Address:
City: Guiyang
Zip: 550002
Country: China

Facility:
Name: Local Institution - 0147

Address:
City: Hankou
Zip: 430023
Country: China

Facility:
Name: Local Institution - 0148

Address:
City: Wuhan
Zip: 210000
Country: China

Facility:
Name: Local Institution - 0150

Address:
City: Wuhan
Zip: 430060
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Name: Local Institution - 0154

Address:
City: Changsha
Zip: 410011
Country: China

Facility:
Name: Local Institution - 0139

Address:
City: Nanjing
Zip: 210009
Country: China

Facility:
Name: Local Institution - 0178

Address:
City: Nanchang
Zip: 330006
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Facility:
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Address:
City: Changchun
Zip: 130012
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Facility:
Name: Local Institution - 0183

Address:
City: Changchun
Zip: 130021
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City: Gongzhuling
Zip: 132000
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Zip: 250117
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City: Shanghai
Zip: 200443
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Zip: 610041
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Address:
City: Chengdu
Zip: 610041
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Address:
City: Hangzhou
Zip: 310000
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Facility:
Name: Local Institution - 0184

Address:
City: Linhai
Zip: 317000
Country: China

Facility:
Name: Local Institution - 0086

Address:
City: Bordeaux
Zip: 33076
Country: France

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Name: Local Institution - 0087

Address:
City: Dijon
Zip: 21000
Country: France

Facility:
Name: Local Institution - 0081

Address:
City: Lyon
Zip: 69008
Country: France

Facility:
Name: Local Institution - 0082

Address:
City: Montpellier
Zip: 34070
Country: France

Facility:
Name: Local Institution - 0084

Address:
City: Nantes
Zip: 44000
Country: France

Facility:
Name: Local Institution - 0090

Address:
City: Paris Cedex 14
Zip: 75679
Country: France

Facility:
Name: Local Institution - 0083

Address:
City: Paris Cedex 5
Zip: 75248
Country: France

Facility:
Name: Local Institution - 0227

Address:
City: Paris
Zip: 75018
Country: France

Facility:
Name: Local Institution - 0091

Address:
City: Paris
Zip: 75020
Country: France

Facility:
Name: Local Institution - 0089

Address:
City: Tours Cedex 09
Zip: 37044
Country: France

Facility:
Name: Local Institution - 0060

Address:
City: Berlin
Zip: 14165
Country: Germany

Facility:
Name: Local Institution - 0063

Address:
City: Essen
Zip: 45136
Country: Germany

Facility:
Name: Local Institution - 0076

Address:
City: Grosshansdorf
Zip: 22927
Country: Germany

Facility:
Name: Local Institution - 0101

Address:
City: Hamm
Zip: 59063
Country: Germany

Facility:
Name: Local Institution - 0073

Address:
City: Heidelberg
Zip: 69126
Country: Germany

Facility:
Name: Local Institution - 0061

Address:
City: Immenhausen
Zip: 34376
Country: Germany

Facility:
Name: Local Institution - 0062

Address:
City: Kempten
Zip: 87439
Country: Germany

Facility:
Name: Local Institution - 0075

Address:
City: Loewenstein
Zip: 74245
Country: Germany

Facility:
Name: Local Institution - 0109

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City: Mainz
Zip: 55131
Country: Germany

Facility:
Name: Local Institution - 0072

Address:
City: Stuttgart
Zip: 70376
Country: Germany

Facility:
Name: Local Institution - 0161

Address:
City: Athens
Zip: 115 22
Country: Greece

Facility:
Name: Local Institution - 0135

Address:
City: Athens
Zip: 11527
Country: Greece

Facility:
Name: Local Institution - 0136

Address:
City: Larissa
Zip: 41110
Country: Greece

Facility:
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Address:
City: N.Kifissia
Zip: 14564
Country: Greece

Facility:
Name: Local Institution - 0024

Address:
City: Dublin 8
Country: Ireland

Facility:
Name: Local Institution - 0023

Address:
City: Dublin
Zip: 00004
Country: Ireland

Facility:
Name: Local Institution - 0068

Address:
City: Brescia
Zip: 25123
Country: Italy

Facility:
Name: Aou Policlinico V. Emanuele Di Catania

Address:
City: Catania
Zip: 95100
Country: Italy

Facility:
Name: Azienda Ospedaliero-Universitaria Mater Domini

Address:
City: Catanzaro
Zip: 88100
Country: Italy

Facility:
Name: Local Institution - 0050

Address:
City: Lucca
Zip: 55100
Country: Italy

Facility:
Name: Local Institution - 0115

Address:
City: Milano
Zip: 20141
Country: Italy

Facility:
Name: Local Institution - 0114

Address:
City: Monza (MB)
Zip: 20900
Country: Italy

Facility:
Name: Local Institution - 0048

Address:
City: Perugia
Zip: 06129
Country: Italy

Facility:
Name: Local Institution - 0204

Address:
City: Nagoya
Zip: 4648681
Country: Japan

Facility:
Name: Local Institution - 0212

Address:
City: Fukuoka-shi
Zip: 8128582
Country: Japan

Facility:
Name: Local Institution - 0211

Address:
City: Kurume-shi
Zip: 8300011
Country: Japan

Facility:
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Address:
City: Ota
Zip: 373-8550
Country: Japan

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Zip: 0030804
Country: Japan

Facility:
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Country: Japan

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Country: Japan

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Address:
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Country: Japan

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Address:
City: Osaka-shi
Zip: 5458586
Country: Japan

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Name: Local Institution - 0210

Address:
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Zip: 589-8511
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Address:
City: Hidaka-shi
Zip: 3501298
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City: Kitaadachi-gun
Zip: 3620806
Country: Japan

Facility:
Name: Local Institution - 0199

Address:
City: Bunkyo-ku
Zip: 113-8603
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Facility:
Name: Local Institution - 0200

Address:
City: Chuo-ku
Zip: 1040045
Country: Japan

Facility:
Name: Local Institution - 0232

Address:
City: Ube
Zip: 755-0241
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Address:
City: Wakayama
Zip: 641-8509
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Facility:
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Address:
City: Cheongju-si, Chungcheonbuk-do,
Zip: 361-711
Country: Korea, Republic of

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Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
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Address:
City: Seoul
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Address:
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Address:
City: Df
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Address:
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Name: Local Institution - 0014

Address:
City: Monterrey
Zip: 64060
Country: Mexico

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Name: Local Institution - 0015

Address:
City: Culiacan
Zip: 80230
Country: Mexico

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Name: Local Institution - 0006

Address:
City: Amsterdam
Zip: 1081HV
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Name: Local Institution - 0025

Address:
City: Arnhem
Zip: 6815 AD
Country: Netherlands

Facility:
Name: Local Institution - 0240

Address:
City: Leiden
Zip: 2333ZA
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Facility:
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Address:
City: Maastrict
Zip: 6229 HX
Country: Netherlands

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Address:
City: Veldhoven
Zip: 5504 DB
Country: Netherlands

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Address:
City: Bydgoszcz
Zip: 85796
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Address:
City: Gdansk
Zip: 80-214
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Address:
City: Krakow
Zip: 31-826
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Name: Local Institution - 0235

Address:
City: Tomaszow Mazowiecki
Zip: 97-200
Country: Poland

Facility:
Name: Local Institution - 0120

Address:
City: Hato Rey
Zip: 00917
Country: Puerto Rico

Facility:
Name: GCM Medical Group, PSC - Hato Rey Site

Address:
City: San Juan
Zip: 917
Country: Puerto Rico

Facility:
Name: Local Institution - 0018

Address:
City: Bucharest
Zip: 022328
Country: Romania

Facility:
Name: Local Institution - 0222

Address:
City: Bucuresti
Zip: 022548
Country: Romania

Facility:
Name: Local Institution - 0019

Address:
City: Cluj-Napoca
Zip: 400015
Country: Romania

Facility:
Name: Local Institution - 0020

Address:
City: Constanta
Zip: 900591
Country: Romania

Facility:
Name: Local Institution - 0017

Address:
City: Craiova
Zip: 200542
Country: Romania

Facility:
Name: Local Institution - 0021

Address:
City: Floresti/ Cluj
Zip: 407280
Country: Romania

Facility:
Name: Local Institution

Address:
City: Moscow
Zip: 105229
Country: Russian Federation

Facility:
Name: Local Institution

Address:
City: Moscow
Zip: 115478
Country: Russian Federation

Facility:
Name: Local Institution

Address:
City: Moscow
Zip: 125367
Country: Russian Federation

Facility:
Name: Local Institution

Address:
City: St. Petersburg
Zip: 197758
Country: Russian Federation

Facility:
Name: Local Institution - 0171

Address:
City: Singapore
Zip: 168583
Country: Singapore

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Name: Local Institution - 0106

Address:
City: Barcelona
Zip: 8025
Country: Spain

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Name: Local Institution - 0099

Address:
City: Hospitalet de Llobregat
Zip: 08907
Country: Spain

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Name: Local Institution - 0096

Address:
City: Madrid
Zip: 28007
Country: Spain

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Name: Local Institution - 0095

Address:
City: Madrid
Zip: 28046
Country: Spain

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Name: Local Institution - 0098

Address:
City: Pamplona
Zip: 31008
Country: Spain

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Name: Local Institution - 0105

Address:
City: Santiago de Compostela
Zip: 15706
Country: Spain

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Name: Local Institution - 0097

Address:
City: Sevilla
Zip: 41013
Country: Spain

Facility:
Name: Local Institution - 0100

Address:
City: Zaragoza
Zip: 50009
Country: Spain

Facility:
Name: Local Institution - 0065

Address:
City: Goteborg
Zip: 41345
Country: Sweden

Facility:
Name: Local Institution - 0064

Address:
City: Stockholm
Zip: 171 76
Country: Sweden

Facility:
Name: Local Institution - 0057

Address:
City: Basel
Zip: 4031
Country: Switzerland

Facility:
Name: Local Institution - 0058

Address:
City: Lausanne
Zip: 1011
Country: Switzerland

Facility:
Name: Local Institution - 0059

Address:
City: St.Gallen
Zip: 9007
Country: Switzerland

Facility:
Name: Local Institution - 0056

Address:
City: Zuerich
Zip: 8091
Country: Switzerland

Facility:
Name: Local Institution - 0208

Address:
City: KaohsiungCity
Zip: 83301
Country: Taiwan

Facility:
Name: Local Institution - 0214

Address:
City: New Taipei City
Zip: 235
Country: Taiwan

Facility:
Name: Local Institution - 0209

Address:
City: Tainan
Zip: 704
Country: Taiwan

Facility:
Name: Local Institution - 0133

Address:
City: Taipei City
Zip: 100
Country: Taiwan

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Name: Local Institution - 0213

Address:
City: Taipei
Zip: 10099
Country: Taiwan

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Name: Local Institution - 0143

Address:
City: Taipei
Zip: 112
Country: Taiwan

Facility:
Name: Local Institution - 0010

Address:
City: Poole
Zip: BH15 2JB
Country: United Kingdom

Facility:
Name: Local Institution - 0012

Address:
City: Swansea
Zip: SA2 8QA
Country: United Kingdom

Facility:
Name: Local Institution - 0054

Address:
City: Aberdeen
Zip: AB25 2ZN
Country: United Kingdom

Facility:
Name: Local Institution - 0007

Address:
City: Bebington
Zip: CH63 4JY
Country: United Kingdom

Facility:
Name: Local Institution - 0009

Address:
City: Hull
Zip: HU16 5JQ
Country: United Kingdom

Start date: October 8, 2019

Completion date: September 16, 2024

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/NCT04026412
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsstudyconnect.com/content/studyconnect/us/en/clinical-trials/NCT04026412.html