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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01673867




Registration number
NCT01673867
Ethics application status
Date submitted
24/08/2012
Date registered
28/08/2012
Date last updated
8/02/2023

Titles & IDs
Public title
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC
Scientific title
An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
2012-002472-14
Secondary ID [2] 0 0
CA209-057
Universal Trial Number (UTN)
Trial acronym
CheckMate057
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-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(has expanded access)
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.

Active comparator: 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 413 deaths, up to March 2015 (approximately 29 months)
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
From randomization to date of objectively documented progression (up to approximately 110 months)
Secondary outcome [2] 0 0
Time To Objective Response (TTOR)
Timepoint [2] 0 0
From randomization to the date of first confirmed response (up to approximately 110 months)
Secondary outcome [3] 0 0
Duration of Objective Response (DOOR)
Timepoint [3] 0 0
From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)
Secondary outcome [4] 0 0
Progression-Free Survival (PFS)
Timepoint [4] 0 0
From randomization to first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)
Secondary outcome [5] 0 0
Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12
Timepoint [5] 0 0
Randomization to Week 12
Secondary outcome [6] 0 0
Overall Survival (OS) by PD-L1 Expression at Baseline
Timepoint [6] 0 0
From randomization to the date of death or last known date alive (up to approximately 110 months)
Secondary outcome [7] 0 0
Objective Response Rate (ORR) by PD-L1 Expression at Baseline
Timepoint [7] 0 0
From randomization to date of objectively documented progression (up to approximately 110 months)

Eligibility
Key inclusion criteria
* Men & women =18 years of age
* Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second or third line of treatment for 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 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 asymptomatic or 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 =10mg daily prednisone (or equivalent)
* Subjects with carcinomatous meningitis
* Subjects with active or recent history of known or suspected autoimmune disease. Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment 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 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), anti-programmed cell death ligand 2 (anti-PD-L2), anti-cluster of differentiation 137 (anti-CD137), or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
* Prior treatment with Docetaxel
* Treatment with any investigational agent within 14 days of first administration of study treatment

Other protocol-defined inclusion/exclusion criteria apply

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
2/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/12/2021
Sample size
Target
Accrual to date
Final
582
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Tweed Heads
Recruitment hospital [2] 0 0
Local Institution - Woolloongabba
Recruitment hospital [3] 0 0
Local Institution - Adelaide
Recruitment hospital [4] 0 0
Local Institution - Kurralta Park
Recruitment hospital [5] 0 0
Local Institution - Frankston
Recruitment hospital [6] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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California
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Connecticut
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Florida
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Georgia
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Illinois
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Maryland
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Massachusetts
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New Hampshire
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Washington
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West Virginia
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Argentina
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Buenos Aires
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Argentina
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La Rioja
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Austria
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Linz
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Austria
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Salzburg
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Austria
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Vienna
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Austria
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Wels
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Brazil
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Bahia
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Brazil
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Ceara
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Brazil
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Brazil
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Rio De Janeiro
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Canada
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Alberta
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Ontario
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Canada
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Quebec
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Chile
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Metropolitana
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Chile
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Valparaiso
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Czechia
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Praha 8
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France
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Creteil
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France
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Dijon Cedex
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France
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La Roche Sur Yon Cedex 9
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France
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Lyon Cedex 08
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France
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Marseille Cedex 20
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France
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Poitiers
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France
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Rennes Cedex 9
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France
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Toulouse
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Germany
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Bad Berka
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Germany
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Grosshansdorf
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Germany
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Heidelberg
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Germany
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Koeln
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Germany
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Mainz
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Germany
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Recklinghausen
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Germany
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Stuttgart
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Germany
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Ulm
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Italy
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Bergamo
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Italy
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Bologna
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Italy
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Meldola (fc)
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Italy
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Milano
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Italy
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Padova
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Italy
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Parma
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Italy
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Perugia
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Italy
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Ravenna
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Italy
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Siena
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Mexico
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Distrito Federal
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Mexico
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Nuevo Leon
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Mexico
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Sonora
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Norway
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Oslo
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Peru
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Lima
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Peru
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Arequipa
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Poland
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Malopolskie
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Poland
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Gdansk
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Poland
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Olsztyn
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Poland
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Szczecin
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Poland
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Warszawa
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Romania
State/province [74] 0 0
Bucuresti
Country [75] 0 0
Romania
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Cluj-Napoca
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Romania
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Craiova
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Romania
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Iasi
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Romania
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Timisoara
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Vizcaya
Country [86] 0 0
Switzerland
State/province [86] 0 0
Basel
Country [87] 0 0
Switzerland
State/province [87] 0 0
Chur

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy
Trial website
https://clinicaltrials.gov/study/NCT01673867
Trial related presentations / publications
Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wojcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, Garcia MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. doi: 10.1200/JCO.20.01605. Epub 2021 Jan 15. Erratum In: J Clin Oncol. 2021 Apr 1;39(10):1190. doi: 10.1200/JCO.21.00546.
Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.
Reck M, Brahmer J, Bennett B, Taylor F, Penrod JR, DeRosa M, Dastani H, Spigel DR, Gralla RJ. Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057. Eur J Cancer. 2018 Oct;102:23-30. doi: 10.1016/j.ejca.2018.05.005. Epub 2018 Aug 10.
Vokes EE, Ready N, Felip E, Horn L, Burgio MA, Antonia SJ, Aren Frontera O, Gettinger S, Holgado E, Spigel D, Waterhouse D, Domine M, Garassino M, Chow LQM, Blumenschein G Jr, Barlesi F, Coudert B, Gainor J, Arrieta O, Brahmer J, Butts C, Steins M, Geese WJ, Li A, Healey D, Crino L. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases. Ann Oncol. 2018 Apr 1;29(4):959-965. doi: 10.1093/annonc/mdy041.
Horn L, Spigel DR, Vokes EE, Holgado E, Ready N, Steins M, Poddubskaya E, Borghaei H, Felip E, Paz-Ares L, Pluzanski A, Reckamp KL, Burgio MA, Kohlhaeufl M, Waterhouse D, Barlesi F, Antonia S, Arrieta O, Fayette J, Crino L, Rizvi N, Reck M, Hellmann MD, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Eberhardt WEE. Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057). J Clin Oncol. 2017 Dec 10;35(35):3924-3933. doi: 10.1200/JCO.2017.74.3062. Epub 2017 Oct 12.
Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01673867