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

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.

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