Houston, Texas 78234

  • Lung Cancer

Purpose:

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.


Study 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. The study will be started in 2016, and data collection will be continued until March 2024.


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


NCT ID:

NCT02847728


Primary Contact:

Study Director
Bristol-Myers Squibb
Bristol-Myers Squibb

Recruiting sites have contact information. Please contact sites directly. If there is no contact information,
Phone: Please email:
Email: clinical.trials@bms.com


Backup Contact:

First line of the email MUST contain NCT # and site #


Location Contact:

Houston, Texas 78234
United States

Peggy Smith, Site: 1905
Phone: 210-916-3332
Email: Peggy.s.smith56.ctr@mail.mil

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 28, 2021

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