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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    1200
  • sponsor
    Bristol-Myers Squibb
Updated on 2 March 2021
cancer
anxiety
lung cancer
nivolumab
ipilimumab
cancer treatment
lung carcinoma

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, Czech Republic, Hungary, Poland 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.

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, Czech Republic, Hungary, Poland 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.

Details
Condition Pulmonary Disease, melanoma, Lung Neoplasm, skin cancer, Bronchial Neoplasm, Metastatic Melanoma, Lung Cancer, Malignant Melanoma, Lung Disease, carcinoma lung, lung carcinoma
Clinical Study IdentifierNCT02847728
SponsorBristol-Myers Squibb
Last Modified on2 March 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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