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Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02847728
Collaborator
(none)
1,189
Enrollment
1
Location
92.1
Anticipated Duration (Months)
12.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an observational, multicenter study in participants treated with nivolumab for the approved indications of melanoma and Lung cancer in Australia, the EU, Switzerland, and the United States (US). The targeted countries in the EU for study participation include Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1189 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
    Actual Study Start Date :
    Jul 28, 2016
    Anticipated Primary Completion Date :
    Mar 31, 2024
    Anticipated Study Completion Date :
    Mar 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Single Arm Design

    The study encompasses a single arm design with 417 adults treated with nivolumab for histologically or cytologically confirmed melanoma and 772 adults treated with nivolumab for histologically or cytologically confirmed lung cancer.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence rate of and severity of immune-related pneumonitis - Melanoma [up to nine years]

    2. Incidence rate of and severity of immune-related colitis- Melanoma [up to nine years]

    3. Incidence rate of and severity of immune-related hepatitis - Melanoma [up to nine years]

    4. Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma [up to nine years]

    5. Incidence rate of and severity of immune-related endocrinopathies - Melanoma [up to nine years]

    6. Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma [up to nine years]

    7. Incidence rate of and severity of other immune-related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Melanoma [up to nine years]

    8. Incidence rate of and severity of severe infusion reactions- Melanoma [up to nine years]

    9. Incidence rate of and severity of immune-related pneumonitis - Lung Cancer [up to nine years]

    10. Incidence rate of and severity of immune-related colitis - Lung Cancer [up to nine years]

    11. Incidence rate of and severity of immune-related hepatitis - Lung Cancer [up to nine years]

    12. Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer [up to nine years]

    13. Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer [up to nine years]

    14. Incidence rate of and severity of other immune related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Lung Cancer [up to nine years]

    15. Incidence rate of and severity of severe infusion reactions - Lung Cancer [up to nine years]

    16. Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer [up to nine years]

    Secondary Outcome Measures

    1. Adverse Events [Up to nine years]

      Other nivolumab treatment-related AEs

    2. Management of Immune-related AEs: [Up to nine years]

    3. Outcomes of Immune-related AEs: [Up to nine years]

    4. Overall Survival: [Up to nine years]

      1-, 2-, 3-, 4-, and 5-year overall and median survival

    5. Nivolumab treatment pattern [Up to nine years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inventiv Princeton New Jersey United States 08540

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02847728
    Other Study ID Numbers:
    • CA209-234
    First Posted:
    Jul 28, 2016
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Mar 9, 2022