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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
24/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/01/2022
Sample size
Target
Accrual to date
Final
363
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
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
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Michigan
Country [16] 0 0
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Minnesota
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Mississippi
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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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State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
Austria
State/province [32] 0 0
Wien
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
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Canada
State/province [34] 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 Cedex 01
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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 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
Country [47] 0 0
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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Germany
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Greifenstein
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Germany
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Hamburg
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Germany
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Hannover
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Kassel
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Germany
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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
Country [61] 0 0
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
Country [68] 0 0
Spain
State/province [68] 0 0
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