An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
NCT ID: NCT02409368
Last Updated: 2022-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
812 participants
INTERVENTIONAL
2015-04-29
2021-08-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Cohort A: Treatment - Nivolumab
Nivolumab IV infusion
Nivolumab
Interventions
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Nivolumab
Eligibility Criteria
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Inclusion Criteria
* Subjects with histologically or cytologically-documented SqNSCLC
* Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen
* Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria
* Subjects with treated or asymptomatic CNS metastases
* Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration
* Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab
* Males and Females, ages 18 or older
Exclusion Criteria
* Subjects with carcinomatous meningitis
* Subjects with active, known or suspected autoimmune disease.
* Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.
18 Years
ALL
No
Sponsors
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PPD Development, LP
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0002
Wels, Upper Austria, Austria
Local Institution - 0003
Salzburg, , Austria
Local Institution - 0005
Vienna, , Austria
Local Institution - 0173
Odense, Region Syddanmark, Denmark
Local Institution - 0021
Aalborg, , Denmark
Local Institution - 0020
Herlev, , Denmark
Local Institution - 0022
Oulu, North Ostrobothnia, Finland
Local Institution - 0023
Pori, , Finland
Local Institution - 0051
Athens, , Greece
Local Institution - 0052
Heraklion, , Greece
Local Institution - 0177
Nea Kifisia Athens, , Greece
Local Institution - 0148
Pátrai, , Greece
Local Institution - 0147
Thessaloniki, , Greece
Local Institution - 0054
Pécs, Baranya, Hungary
Local Institution - 0053
Budapest, , Hungary
Local Institution - 0347
Budapest, , Hungary
Local Institution - 0178
Debrecen, , Hungary
Local Institution - 0056
Dublin, , Ireland
Local Institution - 0058
Galway, , Ireland
Local Institution - 0349
Tullamore, Offaly, , Ireland
Local Institution - 0087
Poznan, Greater Poland Voivodeship, Poland
Local Institution - 0158
Gliwice, Silesian Voivodeship, Poland
Local Institution - 0184
Zabrze, Silesian Voivodeship, Poland
Local Institution - 0086
Gdansk, , Poland
Local Institution - 0088
Lodz, , Poland
Local Institution - 0089
Warsaw, , Poland
Local Institution - 0094
Coimbra, , Portugal
Local Institution - 0093
Lisbon, , Portugal
Local Institution - 0090
Lisbon, , Portugal
Local Institution - 0092
Porto, , Portugal
Local Institution - 0091
Porto, , Portugal
Local Institution - 0159
Porto, , Portugal
Local Institution - 0192
Oradea, Bihor County, Romania
Local Institution - 0098
Cluj-Napoca, Cluj, Romania
Local Institution - 0187
Timișoara, Timiș County, Romania
Local Institution - 0095
Bucharest, , Romania
Local Institution - 0096
Bucharest, , Romania
Local Institution - 0097
Cluj-Napoca, , Romania
Local Institution - 0100
Saint Petersburg, Leningradskaya Oblast', Russia
Local Institution - 0160
Moscow, Moscow, Russia
Local Institution - 0099
Saint Petersburg, Sankt-Peterburg, Russia
Local Institution - 0109
Santander, Cantabria, Spain
Local Institution - 0337
Oviedo, Principality of Asturias, Spain
Local Institution - 0107
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Local Institution - 0104
A Coruña, , Spain
Local Institution - 0119
Alicante, , Spain
Local Institution - 0162
Barcelona, , Spain
Local Institution - 0112
Barcelona, , Spain
Local Institution - 0111
Barcelona, , Spain
Local Institution - 0110
Barcelona, , Spain
Local Institution - 0108
Burgos, , Spain
Local Institution - 0103
Granada, , Spain
Local Institution - 0114
Madrid, , Spain
Local Institution - 0117
Madrid, , Spain
Local Institution - 0116
Madrid, , Spain
Local Institution - 0105
Madrid, , Spain
Local Institution - 0106
Málaga, , Spain
Local Institution - 0113
Palma de Mallorca, , Spain
Local Institution - 0118
Seville, , Spain
Local Institution - 0161
Valencia, , Spain
Local Institution - 0102
Valencia, , Spain
Local Institution - 0163
Zaragoza, , Spain
Local Institution - 0346
Stockholm, Stockholm County, Sweden
Local Institution - 0193
Gothenburg, Västra Götaland County, Sweden
Local Institution - 0348
Linköping, , Sweden
Local Institution - 0342
Lund, , Sweden
Local Institution - 0120
Stockholm, , Sweden
Local Institution - 0339
Örebro, Örebro County, Sweden
Local Institution - 0345
Aberdeen, Aberdeen CITY, United Kingdom
Local Institution - 0127
London, Greater London, United Kingdom
Local Institution - 0191
Manchester, Greater Manchester, United Kingdom
Local Institution - 0131
Southampton, Hampshire, United Kingdom
Local Institution - 0128
Maidstone, Kent, United Kingdom
Local Institution - 0195
Glasgow, Lanarkshire, United Kingdom
Local Institution - 0132
Preston, Lancashire, United Kingdom
Local Institution - 0167
Leicester, Leicestershire, United Kingdom
Local Institution - 0196
Sutton, Surrey, United Kingdom
Local Institution - 0171
Bebington, , United Kingdom
Local Institution - 0340
Bodelwyddan, Rhyl, , United Kingdom
Local Institution - 0344
Bradford, , United Kingdom
Local Institution - 0190
Bristol, , United Kingdom
Local Institution - 0133
Cardiff, , United Kingdom
Local Institution - 0126
Cottingham, , United Kingdom
Local Institution - 0165
London, , United Kingdom
Local Institution - 0169
London, , United Kingdom
Local Institution - 0194
Northwood, , United Kingdom
Local Institution - 0166
Plymouth, , United Kingdom
Local Institution - 0124
Sheffield, , United Kingdom
Local Institution - 0189
Sutton, , United Kingdom
Local Institution - 0338
West Midlands, , United Kingdom
Countries
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References
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Felip E, Ardizzoni A, Ciuleanu T, Cobo M, Laktionov K, Szilasi M, Califano R, Carcereny E, Griffiths R, Paz-Ares L, Duchnowska R, Garcia MA, Isla D, Jassem J, Appel W, Milanowski J, Van Meerbeeck JP, Wolf J, Li A, Acevedo A, Popat S. CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations. Eur J Cancer. 2020 Mar;127:160-172. doi: 10.1016/j.ejca.2019.11.019. Epub 2020 Feb 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2014-001285-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-171
Identifier Type: -
Identifier Source: org_study_id
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