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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/NCT02538666
Registration number
NCT02538666
Ethics application status
Date submitted
26/08/2015
Date registered
2/09/2015
Date last updated
5/01/2023
Titles & IDs
Public title
An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy
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Scientific title
A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)
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Secondary ID [1]
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2015-002441-61
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Secondary ID [2]
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CA209-451
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 451
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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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Condition category
Condition code
Cancer
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0
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Lung - Mesothelioma
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Cancer
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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(has expanded access)
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Ipilimumab
Other interventions - Placebo
Experimental: Nivolumab monotherapy - Nivolumab intravenous fusion
Experimental: Nivolumab and ipilimumab combination therapy - Nivolumab and ipilimumab intravenous fusion
Placebo Comparator: Placebo - Placebo
Other interventions: Nivolumab
Other interventions: Ipilimumab
Other interventions: Placebo
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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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Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population
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Assessment method [1]
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OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug
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Timepoint [1]
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From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months)
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Secondary outcome [1]
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Overall Survival (OS) of Nivolumab Versus Placebo
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Assessment method [1]
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Overall Survival (OS) comparing nivolumab monotherapy versus placebo. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.
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Timepoint [1]
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0
From randomization to the date of death or last known alive date (up to approximately 73 months)
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Secondary outcome [2]
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Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab
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Assessment method [2]
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Overall Survival (OS) comparing Nivolumab + Ipilimumab Versus Nivolumab. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.
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Timepoint [2]
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From randomization to the date of death or last known alive date (up to approximately 73 months)
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Secondary outcome [3]
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Progression Free Survival (PFS) Per BICR
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Assessment method [3]
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PFS was defined as the time between the date of randomization and the first date of documented progression as determined by Blind Independent Central Review (BICR) or death due to any cause, whichever occurred first. Participants who died with no reported progression were considered to have progressed on the date of death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on study tumor assessments and did not die (or died after initiation of the subsequent anti- cancer therapy) were censored on their date of randomization. Participants who started any subsequent anti- cancer therapy without a prior reported Progressive Disease (PD) per BICR were censored at the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.
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Timepoint [3]
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From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)
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Secondary outcome [4]
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Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population
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Assessment method [4]
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Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined.
OS in TMB by the following cutoff points: =10 mutations/mb, < 10 mutations/mb, =13 mutations/mb, <13 mutations/mb
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Timepoint [4]
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From randomization to the date of death or last known alive date (up to approximately 73 months)
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Secondary outcome [5]
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Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population
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Assessment method [5]
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Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined.
PFS in TMB by the following cutoff points: =10 mutations/mb, < 10 mutations/mb, =13 mutations/mb, <13 mutations/mb.
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Timepoint [5]
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From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)
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Eligibility
Key inclusion criteria
- Subjects with histologically or cytologically confirmed extensive stage disease SCLC
- Ongoing response of stable disease or better following 4 cycles of platinum-based
first line chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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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
- Subjects with symptomatic Central Nervous System (CNS) metastases
- Subjects receiving consolidative chest radiation
- Subjects with active, known, or suspected autoimmune disease are excluded
- All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1
or baseline
Other protocol-defined inclusion/exclusion criteria 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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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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
13/10/2015
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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
11/11/2021
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Sample size
Target
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Accrual to date
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Final
907
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Local Institution - Kogarah
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Local Institution - Wollongong
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Local Institution - Birtinya
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Princess Alexandra Hospital - Brisbane
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Local Institution - 0137 - Adelaide
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Recruitment hospital [6]
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Local Institution - 0035 - East Melbourne
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Recruitment postcode(s) [1]
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- Kogarah
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2500 - Wollongong
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4575 - Birtinya
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4102 - Brisbane
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5000 - Adelaide
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Recruitment postcode(s) [6]
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3165 - East Melbourne
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Recruitment outside Australia
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Eindhoven
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Country [118]
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Netherlands
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State/province [118]
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Rotterdam
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Peru
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State/province [119]
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Lima
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Country [120]
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Poland
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State/province [120]
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Gdansk
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Poland
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Gdynia
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Poland
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State/province [122]
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Olsztyn
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Poland
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Warszawa
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Romania
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Bucharest
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Country [125]
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Romania
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Craiova
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Romania
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Lasi
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Country [127]
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Romania
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State/province [127]
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Romania
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Country [128]
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Romania
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State/province [128]
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Timisoara, Timis
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Country [129]
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Russian Federation
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State/province [129]
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Moscow
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Russian Federation
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St Petersburg
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Russian Federation
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State/province [131]
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St. Petersburg
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Country [132]
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Singapore
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Singapore
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Country [133]
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South Africa
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Gauteng
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Country [134]
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South Africa
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Western Cape
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Country [135]
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South Africa
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Western CAPE
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Country [136]
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Spain
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Barcelona
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Country [137]
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Spain
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Madrid
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Country [138]
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Spain
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Malaga
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Country [139]
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Spain
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State/province [139]
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Sevilla
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Country [140]
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Sweden
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State/province [140]
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Lund
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Country [141]
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Sweden
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State/province [141]
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Uppsala
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Switzerland
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State/province [142]
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Aarau
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Country [143]
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Switzerland
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State/province [143]
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Geneve
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Country [144]
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Switzerland
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State/province [144]
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St. Gallen
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Taiwan
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TNN
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Taiwan
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Taoyuan
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United Kingdom
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Cornwall
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Country [148]
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United Kingdom
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State/province [148]
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Greater London
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Country [149]
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United Kingdom
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State/province [149]
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Lancashire
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Country [150]
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United Kingdom
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Oxfordshire
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Country [151]
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United Kingdom
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Surrey
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Country [152]
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United Kingdom
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State/province [152]
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Sheffield
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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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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Ono Pharmaceutical Co. Ltd
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
In this study, all patients must have already completed first-line chemotherapy to treat
extensive-stage disease small cell lung cancer. The purpose of this study is to show that
nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall
survival when administered as consolidation treatment in patients that are stable or
responding after chemotherapy. Patients receiving treatment will be compared with patients
taking placebo.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02538666
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Public notes
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Contacts
Principal investigator
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Bristol Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02538666
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