Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 (CheckMate 384)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02713867
Recruitment Status : Active, not recruiting
First Posted : March 21, 2016
Results First Posted : June 22, 2020
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE March 11, 2016
First Posted Date  ICMJE March 21, 2016
Results First Submitted Date  ICMJE March 10, 2020
Results First Posted Date  ICMJE June 22, 2020
Last Update Posted Date June 22, 2020
Actual Study Start Date  ICMJE April 21, 2016
Actual Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • Progression Free Survival Rate(PFSR) at 6 Months [ Time Frame: at 6 Months ]
    PFS is defined as the time from the date of randomization to the date of first documented tumor progression determined by the investigator or death, whichever is earlier. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment.
  • Progression Free Survival Rate (PFSR) at 12 Months [ Time Frame: at 12 Months ]
    PFS is defined as the time from the date of randomization to the date of first documented tumor progression determined by the investigator or death, whichever is earlier. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment.is earlier. Subjects who did not progress or die will be censored on the date of their last evaluable tumor assessment.
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
  • Progression Free Survival (PFS) rate at 6 months after randomization [ Time Frame: 6 months after randomization ]
  • Progression Free Survival (PFS) rate at 12 months after randomization [ Time Frame: 12 months after randomization ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • Progression Free Survival Rate (PFSR) by Tumor Histology [ Time Frame: 12 Months after Randomization ]
    PFS is defined as the time from the date of randomization to the date of first documented tumor progression determined by the investigator or death, whichever is earlier. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment.is earlier. Subjects who did not progress or die will be censored on the date of their last evaluable tumor assessment.
  • Progression Free Survival Rate (PFSR) by Response Criteria [ Time Frame: 12 Months after Randomization ]
    PFS is defined as the time from the date of randomization to the date of first documented tumor progression determined by the investigator or death, whichever is earlier. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment.is earlier. Subjects who did not progress or die will be censored on the date of their last evaluable tumor assessment.
  • Overall Survival [ Time Frame: Up to 12 Months ]
    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.
  • Overall Survival by Histology [ Time Frame: 12 Months after Randomization ]
    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.
  • Overall Survival by Response Criteria [ Time Frame: 12 Months after Randomization ]
    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.
  • Percentage of Participants With an Adverse Events (AEs) [ Time Frame: between first dose and 100 days after last dose of study therapy ]
    Percentage of Participants with an Adverse Event due to any cause
  • Percentage of Participants With an Serious Adverse Events (SAEs) [ Time Frame: between first dose and 100 days after last dose of study therapy ]
    Percentage of Participants with an Serious Adverse Event due to any cause
  • Percentage of Participants With an Adverse Events Leading to Discontinuation (AEsDC) [ Time Frame: between first dose and 100 days after last dose of study therapy ]
    Percentage of Participants with an Adverse Event leading to discontinuation (AEsDC) due to any cause
  • Percentage of Participants With an Immune Mediated Adverse Events (IMAEs) [ Time Frame: between first dose and 100 days after last dose of study therapy ]
    Percentage of Participants with an Immune Mediated Adverse Events treated with Immune-Modulating Medication
  • Percentage of Participants With an Select Adverse Events [ Time Frame: between first dose and 100 days after last dose of study therapy ]
    Percentage of Participants with an Select Adverse Event due to any cause
  • Percentage of Participants With an Event of Special Interest (ESI) [ Time Frame: between first dose and 100 days after last dose of study therapy ]
    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).
  • Percentage of Participants Who Experienced Death [ Time Frame: between first dose and 100 days after last dose of study therapy ]
    Percentage of Participants who experienced Death due to any cause
  • Number of Participants With Laboratory Test Abnormalities [ Time Frame: between first dose and 100 days after last dose of study therapy ]
    number of participants with any laboratory test result that is clinically significant or meets the definition of an SAE (Grade 3+4 combined)
  • Percentage of Participants With an Adverse Event Leading to Dose Delays (AEsDD) [ Time Frame: between first dose and 100 days after last dose of study therapy ]
    Percentage of Participants with an Adverse Event leading to a Dose Delay due to any cause
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
  • Progression Free Survival (PFS) rate after randomization by tumor histology and by response criteria [ Time Frame: 1 year after randomization ]
  • Progression Free Survival (PFS) rate [ Time Frame: 2 years after randomization ]
  • Overall Survival Rate (OSR) [ Time Frame: Every year up to 5 years after randomization ]
  • Safety and Tolerability assessed by the incidence and severity of adverse events (AEs) [ Time Frame: Randomization Till End of Study (Up to 5 years) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE Biological: Nivolumab
Study Arms  ICMJE
  • Active Comparator: Nivolumab 240 mg
    Nivolumab 240 mg Every 2 Weeks
    Intervention: Biological: Nivolumab
  • Experimental: Nivolumab 480 mg
    Nivolumab 480 mg Every 4 Weeks
    Intervention: Biological: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 2, 2020)
363
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2016)
620
Estimated Study Completion Date  ICMJE June 30, 2022
Actual Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Carcinomatous meningitis
  • Untreated, symptomatic Central nervous system (CNS) metastases
  • Symptomatic interstitial lung disease

Other protocol defined inclusion/exclusion criteria could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   France,   Germany,   Italy,   Spain,   United States
Removed Location Countries Ireland
 
Administrative Information
NCT Number  ICMJE NCT02713867
Other Study ID Numbers  ICMJE CA209-384
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP