Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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 Hampshire
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
United States of America
State/province [18] 0 0
West Virginia
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
La Rioja
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
Brazil
State/province [25] 0 0
Bahia
Country [26] 0 0
Brazil
State/province [26] 0 0
Ceara
Country [27] 0 0
Brazil
State/province [27] 0 0
Rio Grande Do Sul
Country [28] 0 0
Brazil
State/province [28] 0 0
Sao Paulo
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio De Janeiro
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
Chile
State/province [33] 0 0
Metropolitana
Country [34] 0 0
Chile
State/province [34] 0 0
Valparaiso
Country [35] 0 0
Czechia
State/province [35] 0 0
Praha 8
Country [36] 0 0
France
State/province [36] 0 0
Creteil
Country [37] 0 0
France
State/province [37] 0 0
Dijon Cedex
Country [38] 0 0
France
State/province [38] 0 0
La Roche Sur Yon Cedex 9
Country [39] 0 0
France
State/province [39] 0 0
Lyon Cedex 08
Country [40] 0 0
France
State/province [40] 0 0
Marseille Cedex 20
Country [41] 0 0
France
State/province [41] 0 0
Poitiers
Country [42] 0 0
France
State/province [42] 0 0
Rennes Cedex 9
Country [43] 0 0
France
State/province [43] 0 0
Toulouse
Country [44] 0 0
Germany
State/province [44] 0 0
Bad Berka
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
Mainz
Country [49] 0 0
Germany
State/province [49] 0 0
Recklinghausen
Country [50] 0 0
Germany
State/province [50] 0 0
Stuttgart
Country [51] 0 0
Germany
State/province [51] 0 0
Ulm
Country [52] 0 0
Hong Kong
State/province [52] 0 0
Hong Kong
Country [53] 0 0
Hungary
State/province [53] 0 0
Budapest
Country [54] 0 0
Italy
State/province [54] 0 0
Bergamo
Country [55] 0 0
Italy
State/province [55] 0 0
Bologna
Country [56] 0 0
Italy
State/province [56] 0 0
Meldola (fc)
Country [57] 0 0
Italy
State/province [57] 0 0
Milano
Country [58] 0 0
Italy
State/province [58] 0 0
Padova
Country [59] 0 0
Italy
State/province [59] 0 0
Parma
Country [60] 0 0
Italy
State/province [60] 0 0
Perugia
Country [61] 0 0
Italy
State/province [61] 0 0
Ravenna
Country [62] 0 0
Italy
State/province [62] 0 0
Siena
Country [63] 0 0
Mexico
State/province [63] 0 0
Distrito Federal
Country [64] 0 0
Mexico
State/province [64] 0 0
Nuevo Leon
Country [65] 0 0
Mexico
State/province [65] 0 0
Sonora
Country [66] 0 0
Norway
State/province [66] 0 0
Oslo
Country [67] 0 0
Peru
State/province [67] 0 0
Lima
Country [68] 0 0
Peru
State/province [68] 0 0
Arequipa
Country [69] 0 0
Poland
State/province [69] 0 0
Malopolskie
Country [70] 0 0
Poland
State/province [70] 0 0
Gdansk
Country [71] 0 0
Poland
State/province [71] 0 0
Olsztyn
Country [72] 0 0
Poland
State/province [72] 0 0
Szczecin
Country [73] 0 0
Poland
State/province [73] 0 0
Warszawa
Country [74] 0 0
Romania
State/province [74] 0 0
Bucuresti
Country [75] 0 0
Romania
State/province [75] 0 0
Cluj-Napoca
Country [76] 0 0
Romania
State/province [76] 0 0
Craiova
Country [77] 0 0
Romania
State/province [77] 0 0
Iasi
Country [78] 0 0
Romania
State/province [78] 0 0
Timisoara
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Moscow
Country [80] 0 0
Russian Federation
State/province [80] 0 0
St. Petersburg
Country [81] 0 0
Singapore
State/province [81] 0 0
Singapore
Country [82] 0 0
Spain
State/province [82] 0 0
Barcelona
Country [83] 0 0
Spain
State/province [83] 0 0
Madrid
Country [84] 0 0
Spain
State/province [84] 0 0
Sevilla
Country [85] 0 0
Spain
State/province [85] 0 0
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
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/NCT01673867