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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02713867




Registration number
NCT02713867
Ethics application status
Date submitted
11/03/2016
Date registered
21/03/2016
Date last updated
17/09/2018

Titles & IDs
Public title
A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks
Scientific title
A Dose Frequency Optimization, Phase IIIB/IV Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks
Secondary ID [1] 0 0
CA209-384
Universal Trial Number (UTN)
Trial acronym
CheckMate 384
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Other interventions - Nivolumab

Active Comparator: Nivolumab 240 mg - Nivolumab 240 mg Every 2 Weeks

Experimental: Nivolumab 480 mg - Nivolumab 480 mg Every 4 Weeks


Other interventions: Nivolumab


Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) rate at 6 months after randomization
Timepoint [1] 0 0
6 months after randomization
Primary outcome [2] 0 0
Progression Free Survival (PFS) rate at 12 months after randomization
Timepoint [2] 0 0
12 months after randomization
Secondary outcome [1] 0 0
Progression Free Survival (PFS) rate by tumor histology and by response criteria
Timepoint [1] 0 0
1 year after randomization
Secondary outcome [2] 0 0
Progression Free Survival (PFS) rate
Timepoint [2] 0 0
2 years after randomization
Secondary outcome [3] 0 0
Overall Survival Rate (OSR)
Timepoint [3] 0 0
Up to 3 years after randomization
Secondary outcome [4] 0 0
Safety and Tolerability assessed by the incidence and severity of adverse events (AEs)
Timepoint [4] 0 0
Randomization until End of Study (Up to 3 years)

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



- Histologically or cytologically documented Squamous or non-Squamous Non-small cell
lung cancer (NSCLC) (Stage IIIB/IV), or recurrent or progressive disease following
multimodal therapy

- Patients must have received pre-study nivolumab for up to 12 months and have 2
consecutive tumor assessments confirming Complete response (CR), Partial response
(PR), or Stable disease (SD)

- Measurable disease before start of pre-study nivolumab treatment

- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Carcinomatous meningitis

- Untreated, symptomatic Central nervous system (CNS) metastases

- Symptomatic interstitial lung disease

Other protocol defined inclusion/exclusion criteria could 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - St. Leonards
Recruitment hospital [2] 0 0
Local Institution - Waratah
Recruitment hospital [3] 0 0
Local Institution - Westmead
Recruitment hospital [4] 0 0
Local Institution - Woolloongabba
Recruitment hospital [5] 0 0
Local Institution - Adelaide
Recruitment hospital [6] 0 0
Local Institution - Bedford Park
Recruitment hospital [7] 0 0
Local Institution - Hobart
Recruitment hospital [8] 0 0
Local Institution - Heidelberg
Recruitment hospital [9] 0 0
Local Institution - Murdoch
Recruitment hospital [10] 0 0
Local Institution - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5037 - Adelaide
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment postcode(s) [10] 0 0
5112 - Elizabeth Vale
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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California
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Colorado
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State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
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United States of America
State/province [10] 0 0
Kentucky
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United States of America
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Louisiana
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Maine
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Maryland
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Michigan
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Minnesota
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Mississippi
Country [17] 0 0
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Missouri
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Nebraska
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New York
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North Carolina
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Ohio
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Oregon
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South Carolina
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South Dakota
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Tennessee
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Texas
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Virginia
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Washington
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Austria
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Wien
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Canada
State/province [30] 0 0
Ontario
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Canada
State/province [31] 0 0
Quebec
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France
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Angers
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France
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Bayonne
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France
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Clermont-Ferrand
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France
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Le Mans
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France
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Mulhouse
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Nimes
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France
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Paris
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France
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Pontoise
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France
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Suresnes
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France
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Tours
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France
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Vandoeuvre-les-Nancy
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France
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Villefranche-sur-Saone
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Germany
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Bad Berka
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Freiburg
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Germany
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Gauting
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Germany
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Greifenstein
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Hamburg
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Hannover
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Kassel
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Kiel
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Leipzig
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Lostau
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Moers
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Nurnberg
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Lucca
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Monza
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Italy
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Napoli
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Roma
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Spain
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El Palmar
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Las Palmas de Gran Canaria
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Spain
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Sabadell-Barcelona
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Spain
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Seville

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to compare PFS (progression-free survival) rate at 6
months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab
240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and
Sq).
Trial website
https://clinicaltrials.gov/show/NCT02713867
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

Summary results
Other publications