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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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0
CA209-384
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 384
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer
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0
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Condition category
Condition code
Cancer
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0
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Lung - Mesothelioma
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Cancer
0
0
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0
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Lung - Non small cell
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Cancer
0
0
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival Rate (PFSR) at 6 Months
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Assessment method [1]
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The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.
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Timepoint [1]
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0
At 6 Months
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Primary outcome [2]
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0
Progression Free Survival Rate (PFSR) at 12 Months
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Assessment method [2]
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The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.
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Timepoint [2]
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0
At 12 Months
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Secondary outcome [1]
0
0
Progression Free Survival Rate (PFSR) at 24 Months
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Assessment method [1]
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The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.
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Timepoint [1]
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0
At 24 Months
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Secondary outcome [2]
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Progression Free Survival Rate (PFSR) by Tumor Histology at 12 Months
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Assessment method [2]
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The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.
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Timepoint [2]
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0
At 12 Months
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Secondary outcome [3]
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Progression Free Survival Rate (PFSR) by Response Criteria at 12 Months
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Assessment method [3]
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The proportion of participants remaining progression free and surviving at 12 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Stable Disease (SD): Neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
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Timepoint [3]
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At 12 Months
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Secondary outcome [4]
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Overall Survival (OS) Rate at 12 Months
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Assessment method [4]
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The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.
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Timepoint [4]
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At 12 Months
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Secondary outcome [5]
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Overall Survival (OS) Rate up to 60 Months
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Assessment method [5]
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The proportion of participants alive up to 60 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.
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Timepoint [5]
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From randomization to the date of death, Up to 60 Months
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Secondary outcome [6]
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Overall Survival Rate by Histology at 12 Months
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Assessment method [6]
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The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.
OS rate by histology did not have data collected after 12 months randomization.
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Timepoint [6]
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at 12 Months
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Secondary outcome [7]
0
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Overall Survival Rate by Response Criteria at 12 Months
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Assessment method [7]
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The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Stable Disease (SD): Neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
OS rate by response did not have data collected after 12 months randomization.
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Timepoint [7]
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12 Months
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Secondary outcome [8]
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Percentage of Participants With an Adverse Events (AEs)
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Assessment method [8]
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Percentage of participants with an Adverse Event due to any cause
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
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Timepoint [8]
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Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
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Secondary outcome [9]
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Percentage of Participants With an Serious Adverse Events (SAEs)
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Assessment method [9]
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Percentage of participants with an Serious Adverse Event due to any cause.
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
results in death
is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)
requires inpatient hospitalization or causes prolongation of existing hospitalization
results in persistent or significant disability/incapacity
is a congenital anomaly/birth defect
is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention [eg, medical, surgical] to prevent one of the other serious outcomes listed in the definition above.)
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Timepoint [9]
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Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
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Secondary outcome [10]
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Percentage of Participants With an Adverse Events Leading to Discontinuation (AEsDC)
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Assessment method [10]
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Percentage of Participants with an Adverse Event leading to discontinuation (AEsDC) due to any cause.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
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Timepoint [10]
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Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
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Secondary outcome [11]
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Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)
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Assessment method [11]
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Percentage of Participants with an Immune Mediated Adverse Events treated with Immune-Modulating Medication
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Timepoint [11]
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Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
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Secondary outcome [12]
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Percentage of Participants With an Select Adverse Events
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Assessment method [12]
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Percentage of Participants with an Select Adverse Event due to any cause
Select adverse events include adverse events in the following systems: Gastrointestinal, Hepatic, Pulmonary, Renal, Skin, Hypersensitivity/Infusion reaction and Endocrine.
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Timepoint [12]
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Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
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Secondary outcome [13]
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Percentage of Participants With an Event of Special Interest (ESI)
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Assessment method [13]
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Other ESI included the following categories: demyelination, encephalitis, Guillain-Barré syndrome (GBS), myasthenic syndrome, pancreatitis, uveitis, myositis, myocarditis, rhabdomyolysis, and Graft Versus Host Disease (GVHD).
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Timepoint [13]
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Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
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Secondary outcome [14]
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Percentage of Participants Who Experienced Death
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Assessment method [14]
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Percentage of Participants who experienced Death due to any cause
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Timepoint [14]
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Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
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Secondary outcome [15]
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Number of Participants With Laboratory Test Abnormalities
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Assessment method [15]
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Number of participants with any laboratory test result that is clinically significant or meets the definition of an SAE (Grade 3+4 combined)
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Timepoint [15]
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Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Carcinomatous meningitis
- Untreated, symptomatic Central nervous system (CNS) metastases
- Symptomatic interstitial lung disease
Other protocol defined inclusion/exclusion criteria could apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/05/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/01/2022
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Sample size
Target
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Accrual to date
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Final
363
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0052 - St. Leonards
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Recruitment hospital [2]
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Local Institution - 0118 - Waratah
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Recruitment hospital [3]
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Local Institution - 0117 - Westmead,
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Recruitment hospital [4]
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Local Institution - 0093 - Woolloongabba
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Recruitment hospital [5]
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Local Institution - 0054 - Bedford Park
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Recruitment hospital [6]
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Local Institution - 0056 - Elizabeth Vale
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Recruitment hospital [7]
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Local Institution - 0055 - Kurralta Park
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Recruitment hospital [8]
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Local Institution - 0057 - Hobart
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Recruitment hospital [9]
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Local Institution - 0053 - Heidelberg
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Recruitment hospital [10]
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Local Institution - 0058 - Murdoch
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Recruitment postcode(s) [1]
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2065 - St. Leonards
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Recruitment postcode(s) [2]
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2298 - Waratah
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Recruitment postcode(s) [3]
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2145 - Westmead,
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment postcode(s) [5]
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5042 - Bedford Park
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Recruitment postcode(s) [6]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [7]
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5037 - Kurralta Park
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Recruitment postcode(s) [8]
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7000 - Hobart
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Recruitment postcode(s) [9]
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3084 - Heidelberg
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Recruitment postcode(s) [10]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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Alabama
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California
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Colorado
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Lostau
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Moers
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Germany
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Nürnberg
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Italy
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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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State/province [68]
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02713867
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02713867
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