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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 : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease
Melanoma Lung Cancer

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
Estimated Enrollment : 1200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
Study Start Date : July 31, 2016
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Group/Cohort
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.



Primary Outcome Measures :
  1. Incidence rate of and severity of immune-related pneumonitis - Melanoma [ Time Frame: up to nine years ]
  2. Incidence rate of and severity of immune-related colitis- Melanoma [ Time Frame: up to nine years ]
  3. Incidence rate of and severity of immune-related hepatitis - Melanoma [ Time Frame: up to nine years ]
  4. Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma [ Time Frame: up to nine years ]
  5. Incidence rate of and severity of immune-related endocrinopathies - Melanoma [ Time Frame: up to nine years ]
  6. Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma [ Time Frame: 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 [ Time Frame: up to nine years ]
  8. Incidence rate of and severity of severe infusion reactions- Melanoma [ Time Frame: up to nine years ]
  9. Incidence rate of and severity of immune-related pneumonitis - Lung Cancer [ Time Frame: up to nine years ]
  10. Incidence rate of and severity of immune-related colitis - Lung Cancer [ Time Frame: up to nine years ]
  11. Incidence rate of and severity of immune-related hepatitis - Lung Cancer [ Time Frame: up to nine years ]
  12. Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer [ Time Frame: up to nine years ]
  13. Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer [ Time Frame: 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 [ Time Frame: up to nine years ]
  15. Incidence rate of and severity of severe infusion reactions - Lung Cancer [ Time Frame: up to nine years ]
  16. Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer [ Time Frame: up to nine years ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to nine years ]
    Other nivolumab treatment-related AEs

  2. Management of Immune-related AEs: [ Time Frame: Up to nine years ]
  3. Outcomes of Immune-related AEs: [ Time Frame: Up to nine years ]
  4. Overall Survival: [ Time Frame: Up to nine years ]
    1-, 2-, 3-, 4-, and 5-year overall and median survival

  5. Nivolumab treatment pattern [ Time Frame: Up to nine years ]


Information from the National Library of Medicine

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


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): NCT02847728


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 #

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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02847728     History of Changes
Other Study ID Numbers: CA209-234
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Nivolumab
Antineoplastic Agents