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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01642004




Registration number
NCT01642004
Ethics application status
Date submitted
9/07/2012
Date registered
17/07/2012
Date last updated
28/12/2022

Titles & IDs
Public title
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)
Scientific title
An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
2011-004792-36
Secondary ID [2] 0 0
CA209-017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Arm A: Nivolumab - Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.

Experimental: Arm B: Docetaxel - Docetaxel 75 mg/m\^2 concentrate for solution for intravenous infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
Timepoint [1] 0 0
Randomization until 199 deaths, up to November 2014, approximately 25 months
Primary outcome [2] 0 0
Overall Survival (OS) Rate in All Randomized Participants
Timepoint [2] 0 0
Randomization to 18 months post-randomization, up to June 2015
Primary outcome [3] 0 0
Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint
Timepoint [3] 0 0
Randomization until 199 deaths, up to November 2014, approximately 25 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) in All Randomized Participants
Timepoint [1] 0 0
From the date of randomization up to the date of objectively documented progression, up to approximately 103 months
Secondary outcome [2] 0 0
Time To Response (TTR) in Months for All Confirmed Responders
Timepoint [2] 0 0
From the date of randomization to the date of the first confirmed response, up to approximately 12 months
Secondary outcome [3] 0 0
Duration of Objective Response (DOR) in Months for All Confirmed Responders
Timepoint [3] 0 0
From the date of first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 94 months
Secondary outcome [4] 0 0
Progression Free Survival Rate (PFSR)
Timepoint [4] 0 0
From randomization to specified timepoints, up to 84 months
Secondary outcome [5] 0 0
Progression-Free Survival (PFS) Time in Months for All Randomized Participants
Timepoint [5] 0 0
From randomization up to the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 103 months
Secondary outcome [6] 0 0
Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12
Timepoint [6] 0 0
From randomization up to Week 12
Secondary outcome [7] 0 0
Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants
Timepoint [7] 0 0
From the date of randomization to the date of death from any cause, up to approximately 103 months
Secondary outcome [8] 0 0
Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants
Timepoint [8] 0 0
From the date of randomization up to the date of objectively documented progression, up to approximately 103 months
Secondary outcome [9] 0 0
Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants
Timepoint [9] 0 0
From the date of first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 103 months

Eligibility
Key inclusion criteria
* Men and women =18 years of age
* Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced disease)
* Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
* Measurable disease by computed tomography (CT)/Magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status =1
* A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of =10 mg daily prednisone (or equivalent)
* Subjects with carcinomatous meningitis
* Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
* Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
* Prior therapy with anti-Programmed death-1 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
* Prior treatment on the first line study CA184104 first line NSCLC study
* Prior treatment with Docetaxel
* Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
* Treatment with any investigational agent within 14 days of first administration of study treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/08/2021
Sample size
Target
Accrual to date
Final
272
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0073 - Wollongong
Recruitment hospital [2] 0 0
Local Institution - 0159 - Adelaide
Recruitment hospital [3] 0 0
Local Institution - 0140 - Elizabeth Vale
Recruitment hospital [4] 0 0
Local Institution - 0158 - Kurralta Park
Recruitment hospital [5] 0 0
Local Institution - 0085 - Clayton
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
United States of America
State/province [17] 0 0
West Virginia
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Tucuman
Country [20] 0 0
Argentina
State/province [20] 0 0
Cordoba
Country [21] 0 0
Austria
State/province [21] 0 0
Linz
Country [22] 0 0
Austria
State/province [22] 0 0
Salzburg
Country [23] 0 0
Austria
State/province [23] 0 0
Vienna
Country [24] 0 0
Austria
State/province [24] 0 0
Wels
Country [25] 0 0
Canada
State/province [25] 0 0
Manitoba
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
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Chile
State/province [27] 0 0
Metropolitana
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Chile
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Valparaiso
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Chile
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Antofagasta
Country [30] 0 0
Chile
State/province [30] 0 0
Santiago
Country [31] 0 0
Czechia
State/province [31] 0 0
Praha 8
Country [32] 0 0
France
State/province [32] 0 0
Avignon Cedes 9
Country [33] 0 0
France
State/province [33] 0 0
Caen
Country [34] 0 0
France
State/province [34] 0 0
Dijon
Country [35] 0 0
France
State/province [35] 0 0
La Roche Sur Yon Cedex 9
Country [36] 0 0
France
State/province [36] 0 0
Lyon Cedex 08
Country [37] 0 0
France
State/province [37] 0 0
Marseille Cedex 20
Country [38] 0 0
France
State/province [38] 0 0
Pierre Benite
Country [39] 0 0
France
State/province [39] 0 0
Rennes Cedex 9
Country [40] 0 0
France
State/province [40] 0 0
Strasbourg
Country [41] 0 0
France
State/province [41] 0 0
Toulouse
Country [42] 0 0
Germany
State/province [42] 0 0
Bad Berka
Country [43] 0 0
Germany
State/province [43] 0 0
Essen
Country [44] 0 0
Germany
State/province [44] 0 0
Gerlingen
Country [45] 0 0
Germany
State/province [45] 0 0
Grosshansdorf
Country [46] 0 0
Germany
State/province [46] 0 0
Heidelberg
Country [47] 0 0
Germany
State/province [47] 0 0
Koeln
Country [48] 0 0
Germany
State/province [48] 0 0
Krefeld
Country [49] 0 0
Hungary
State/province [49] 0 0
Budapest
Country [50] 0 0
Ireland
State/province [50] 0 0
Dublin
Country [51] 0 0
Italy
State/province [51] 0 0
Bologna
Country [52] 0 0
Italy
State/province [52] 0 0
Meldola (fc)
Country [53] 0 0
Italy
State/province [53] 0 0
Milano
Country [54] 0 0
Italy
State/province [54] 0 0
Padova
Country [55] 0 0
Italy
State/province [55] 0 0
Perugia
Country [56] 0 0
Italy
State/province [56] 0 0
Ravenna
Country [57] 0 0
Italy
State/province [57] 0 0
Siena
Country [58] 0 0
Mexico
State/province [58] 0 0
Distrito Federal
Country [59] 0 0
Mexico
State/province [59] 0 0
Guanajuato
Country [60] 0 0
Mexico
State/province [60] 0 0
Sonora
Country [61] 0 0
Netherlands
State/province [61] 0 0
Amsterdam
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Netherlands
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Rotterdam
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Norway
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Oslo
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Peru
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Arequipa
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Peru
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Lima
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Poland
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Gdansk
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Poland
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Krakow
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Poland
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Olsztyn
Country [69] 0 0
Poland
State/province [69] 0 0
Szczecin
Country [70] 0 0
Poland
State/province [70] 0 0
Warszawa
Country [71] 0 0
Romania
State/province [71] 0 0
Bucuresti
Country [72] 0 0
Romania
State/province [72] 0 0
Cluj-Napoca
Country [73] 0 0
Romania
State/province [73] 0 0
Constanta
Country [74] 0 0
Romania
State/province [74] 0 0
Craiova
Country [75] 0 0
Romania
State/province [75] 0 0
Iasi
Country [76] 0 0
Romania
State/province [76] 0 0
Timisoara
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Moscow
Country [78] 0 0
Russian Federation
State/province [78] 0 0
St. Petersburg
Country [79] 0 0
Spain
State/province [79] 0 0
Vizcaya
Country [80] 0 0
Spain
State/province [80] 0 0
Barcelona
Country [81] 0 0
Spain
State/province [81] 0 0
Madrid
Country [82] 0 0
Spain
State/province [82] 0 0
Sevilla
Country [83] 0 0
United Kingdom
State/province [83] 0 0
East Yorkshire
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Hampshire
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Manchester
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01642004