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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02713867
Ethics application status
Date submitted
11/03/2016
Date registered
21/03/2016
Date last updated
14/02/2023

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

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

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival Rate (PFSR) at 6 Months
Timepoint [1] 0 0
At 6 Months
Primary outcome [2] 0 0
Progression Free Survival Rate (PFSR) at 12 Months
Timepoint [2] 0 0
At 12 Months
Secondary outcome [1] 0 0
Progression Free Survival Rate (PFSR) at 24 Months
Timepoint [1] 0 0
At 24 Months
Secondary outcome [2] 0 0
Progression Free Survival Rate (PFSR) by Tumor Histology at 12 Months
Timepoint [2] 0 0
At 12 Months
Secondary outcome [3] 0 0
Progression Free Survival Rate (PFSR) by Response Criteria at 12 Months
Timepoint [3] 0 0
At 12 Months
Secondary outcome [4] 0 0
Overall Survival (OS) Rate at 12 Months
Timepoint [4] 0 0
At 12 Months
Secondary outcome [5] 0 0
Overall Survival (OS) Rate up to 60 Months
Timepoint [5] 0 0
From randomization to the date of death, Up to 60 Months
Secondary outcome [6] 0 0
Overall Survival Rate by Histology at 12 Months
Timepoint [6] 0 0
at 12 Months
Secondary outcome [7] 0 0
Overall Survival Rate by Response Criteria at 12 Months
Timepoint [7] 0 0
12 Months
Secondary outcome [8] 0 0
Percentage of Participants With an Adverse Events (AEs)
Timepoint [8] 0 0
Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Secondary outcome [9] 0 0
Percentage of Participants With an Serious Adverse Events (SAEs)
Timepoint [9] 0 0
Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Secondary outcome [10] 0 0
Percentage of Participants With an Adverse Events Leading to Discontinuation (AEsDC)
Timepoint [10] 0 0
Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Secondary outcome [11] 0 0
Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)
Timepoint [11] 0 0
Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Secondary outcome [12] 0 0
Percentage of Participants With an Select Adverse Events
Timepoint [12] 0 0
Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Secondary outcome [13] 0 0
Percentage of Participants With an Event of Special Interest (ESI)
Timepoint [13] 0 0
Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Secondary outcome [14] 0 0
Percentage of Participants Who Experienced Death
Timepoint [14] 0 0
Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Secondary outcome [15] 0 0
Number of Participants With Laboratory Test Abnormalities
Timepoint [15] 0 0
Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

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
Sex
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
Completed
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 - 0052 - St. Leonards
Recruitment hospital [2] 0 0
Local Institution - 0118 - Waratah
Recruitment hospital [3] 0 0
Local Institution - 0117 - Westmead,
Recruitment hospital [4] 0 0
Local Institution - 0093 - Woolloongabba
Recruitment hospital [5] 0 0
Local Institution - 0054 - Bedford Park
Recruitment hospital [6] 0 0
Local Institution - 0056 - Elizabeth Vale
Recruitment hospital [7] 0 0
Local Institution - 0055 - Kurralta Park
Recruitment hospital [8] 0 0
Local Institution - 0057 - Hobart
Recruitment hospital [9] 0 0
Local Institution - 0053 - Heidelberg
Recruitment hospital [10] 0 0
Local Institution - 0058 - Murdoch
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
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [7] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [8] 0 0
7000 - Hobart
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
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
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maine
Country [13] 0 0
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State/province [13] 0 0
Maryland
Country [14] 0 0
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State/province [14] 0 0
Massachusetts
Country [15] 0 0
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Michigan
Country [16] 0 0
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State/province [16] 0 0
Minnesota
Country [17] 0 0
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Mississippi
Country [18] 0 0
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Missouri
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Nebraska
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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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Oregon
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Pennsylvania
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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
Country [31] 0 0
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Washington
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Austria
State/province [32] 0 0
Wien
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Ontario
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Canada
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Angers
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Bayonne
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Clermont-Ferrand Cedex 01
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France
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Le Mans
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Mulhouse
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Nimes
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Paris
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Pontoise
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Suresnes Cedex
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France
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Tours
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France
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Vandoeuvre-les-Nancy
Country [46] 0 0
France
State/province [46] 0 0
Villefranche-sur-Saone Cedex
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Germany
State/province [47] 0 0
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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Greifenstein
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Germany
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Hamburg
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Hannover
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Kassel
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Kiel
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Germany
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Leipzig
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Germany
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Lostau
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Germany
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Moers
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Germany
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Nürnberg
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Italy
State/province [61] 0 0
Localita San Filippo Lucca
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Italy
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Monza
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Italy
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Napoli
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Italy
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Roma
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Spain
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Barcelona
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Spain
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El Palmar
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Spain
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Las Palmas de Gran Canaria
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Spain
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Sevilla

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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02713867