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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)

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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

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).

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: Nivolumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 21, 2016
Actual Primary Completion Date : July 15, 2019
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Active Comparator: Nivolumab 240 mg
Nivolumab 240 mg Every 2 Weeks
Biological: Nivolumab
Experimental: Nivolumab 480 mg
Nivolumab 480 mg Every 4 Weeks
Biological: Nivolumab



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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).

  12. 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

  13. 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)

  14. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713867


Locations
Show Show 119 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Statistical Analysis Plan  [PDF] September 28, 2018
Study Protocol  [PDF] November 3, 2015

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02713867    
Other Study ID Numbers: CA209-384
First Posted: March 21, 2016    Key Record Dates
Results First Posted: June 22, 2020
Last Update Posted: June 22, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents