Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice (CA209234)

Study identification

• EU PAS number:
  EUPAS14071
• Study ID:
  39427
• Official title and acronym:
  Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice (CA209234)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Belgium

  Czechia

  France

  Germany

  Hungary

  Italy

  Poland

  Spain

  Switzerland

  United Kingdom

  United States
• Study description:
  This is an observational, single-arm, multicenter, prospective cohort 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 population includes 400 adults treated with nivolumab for histologically or cytologically confirmed melanoma and 800 adults treated with nivolumab for histologically or cytologically confirmed lung cancer. The study will be started in 2016, and data collection will be continued until March 2024.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Planned:17/07/2015

Actual:17/07/2015

Study start date

Planned:31/07/2016

Actual:29/07/2016

Data analysis start date

Planned:30/08/2016

Actual:29/07/2016

Date of interim report, if expected

Planned:11/09/2018

Actual:10/09/2018

Date of final study report

Planned:31/12/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol Myers Squibb

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)