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Trial record 1 of 1 for:    NCT02847728
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Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice

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ClinicalTrials.gov Identifier: NCT02847728
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date June 28, 2016
First Posted Date July 28, 2016
Last Update Posted Date June 9, 2020
Study Start Date July 31, 2016
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2017)
  • Incidence rate of and severity of immune-related pneumonitis - Melanoma [ Time Frame: up to nine years ]
  • Incidence rate of and severity of immune-related colitis- Melanoma [ Time Frame: up to nine years ]
  • Incidence rate of and severity of immune-related hepatitis - Melanoma [ Time Frame: up to nine years ]
  • Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma [ Time Frame: up to nine years ]
  • Incidence rate of and severity of immune-related endocrinopathies - Melanoma [ Time Frame: up to nine years ]
  • Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma [ Time Frame: up to nine years ]
  • Incidence rate of and severity of other immune-related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Melanoma [ Time Frame: up to nine years ]
  • Incidence rate of and severity of severe infusion reactions- Melanoma [ Time Frame: up to nine years ]
  • Incidence rate of and severity of immune-related pneumonitis - Lung Cancer [ Time Frame: up to nine years ]
  • Incidence rate of and severity of immune-related colitis - Lung Cancer [ Time Frame: up to nine years ]
  • Incidence rate of and severity of immune-related hepatitis - Lung Cancer [ Time Frame: up to nine years ]
  • Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer [ Time Frame: up to nine years ]
  • Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer [ Time Frame: up to nine years ]
  • Incidence rate of and severity of other immune related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Lung Cancer [ Time Frame: up to nine years ]
  • Incidence rate of and severity of severe infusion reactions - Lung Cancer [ Time Frame: up to nine years ]
  • Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer [ Time Frame: up to nine years ]
Original Primary Outcome Measures
 (submitted: July 25, 2016)
  • Composite of incidence rate of and severity of immune-related pneumonitis - Melanoma [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of immune-related colitis- Melanoma [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of immune-related hepatitis - Melanoma [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of immune-related endocrinopathies - Melanoma [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of immune-related other immune-related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Melanoma [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of severe infusion reactions in patients treated with nivolumab for melanoma.- Melanoma [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of immune-related pneumonitis - Lung Cancer [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of immune-related colitis - Lung Cancer [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of immune-related hepatitis - Lung Cancer [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of immune-related endocrinopathies - Lung Cancer [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of immune-related other immune-related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Lung Cancer [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of severe infusion reactions in patients treated with nivolumab for lung cancer.- Lung Cancer [ Time Frame: up to nine years ]
  • Composite of incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer [ Time Frame: up to nine years ]
Change History
Current Secondary Outcome Measures
 (submitted: April 25, 2017)
  • Adverse Events [ Time Frame: Up to nine years ]
    Other nivolumab treatment-related AEs
  • Management of Immune-related AEs: [ Time Frame: Up to nine years ]
  • Outcomes of Immune-related AEs: [ Time Frame: Up to nine years ]
  • Overall Survival: [ Time Frame: Up to nine years ]
    1-, 2-, 3-, 4-, and 5-year overall and median survival
  • Nivolumab treatment pattern [ Time Frame: Up to nine years ]
Original Secondary Outcome Measures
 (submitted: July 25, 2016)
  • Adverse Events [ Time Frame: Up to nine years ]
    Other nivolumab treatment-related AEs
  • Composite of management of Immune-related AEs: [ Time Frame: Up to nine years ]
    • AE diagnostic/laboratory test
    • Specialist consultation
    • Action with respect to nivolumab treatment
    • Treatment with systemic corticosteroids
    • Doses and duration of corticosteroids tapering
    • Use of non-corticosteroid immunosuppressive agents
    • Use of hormone therapy
    • Treatment with anti-infective agents
    • Other treatment modalities for AE management
    • Agents/procedures used to alleviate symptoms
  • Composite of outcomes of Immune-related AEs: [ Time Frame: Up to nine years ]
    • Median time to resolution
    • Grade of AE at resolution
    • Yes/no and dates of event resolution, resolving, resolution with sequelae, complications (specify), or death
  • Overall Survival: [ Time Frame: Up to nine years ]
    1-, 2-, 3-, 4-, and 5-year overall and median survival
  • Nivolumab treatment pattern [ Time Frame: Up to nine years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
Official Title Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
Brief Summary This is an observational, multicenter study in patients treated with nivolumab for the approved indications of melanoma and lung cancer in Australia, the EU, Switzerland, and the United States (US). Targeted countries in the EU for study participation include Austria, Belgium, France, Germany, Italy, Spain, and the United Kingdom (UK). Study objectives are to assess the safety experience, survival, adverse event management, and outcomes of adverse events associated with nivolumab in routine oncology care facilities.
Detailed Description This is an observational, multicenter study in patients treated with nivolumab for the approved indications of melanoma and lung cancer in Australia, the EU, Switzerland, and the United States (US). Targeted countries in the EU for study participation include Austria, Belgium, France, Germany, Italy, Spain, and the United Kingdom (UK). Study objectives are to assess the safety experience, survival, adverse event management, and outcomes of adverse events associated with nivolumab in routine oncology care facilities. The study will be started in 2016, and data collection will be continued until March 2024.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population consists of 400 adults treated with nivolumab for histologically or cytologically confirmed melanoma and 800 adults treated with nivolumab for histologically or cytologically confirmed lung cancer in accordance with the approved indications in Australia, the EU, Switzerland, and the US. Target EU countries for patient enrollment include Austria, Belgium, France, Germany, Italy, Spain, and the UK. Patients who begin treatment with nivolumab for the first time will be enrolled in accordance with the approved indications and whose treatment strategy was determined independently from consideration of study participation. Treatment will be determined at the treating physician's discretion and with the patient's consent.
Condition
  • Melanoma
  • Lung Cancer
Intervention Not Provided
Study Groups/Cohorts Single Arm Design
The study encompasses a single arm design with 400 adults treated with nivolumab for histologically or cytologically confirmed melanoma and 800 adults treated with nivolumab for histologically or cytologically confirmed lung cancer.
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 Recruiting
Estimated Enrollment
 (submitted: July 25, 2016)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age ≥18
  • Histologically or cytologically confirmed diagnosis of melanoma (including uveal melanoma) or lung cancer
  • Treatment with commercial nivolumab for the first time, alone or in combination with ipilimumab, for the approved indications of nivolumab within 14 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy is determined before an informed consent to study participation, and treatment is initiated within 28 days after informed consent

Exclusion Criteria:

  • Prior participation in a clinical trial within the past 4 weeks
  • Previously treated with anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies
  • Previously treated with anti-CTLA-4 for lung cancer
  • Current or pending participation in a clinical trial
  • Current or pending systemic treatment for cancer other than melanoma and lung cancer
  • Inability to comply with the study protocol

Other protocol defined inclusion and exclusion criteria could apply

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Recruiting sites have contact information. Please contact sites directly. If there in no contact information, Please email: clinical.trials@bms.com
Contact: First line of the email MUST contain NCT # and site #
Listed Location Countries Australia,   Austria,   Belgium,   France,   Germany,   Italy,   Puerto Rico,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02847728
Other Study ID Numbers CA209-234
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators Not Provided
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date June 2020