An observational study in Melanoma and Lung Cancer, sponsored by Bristol-Myers Squibb. Completed at 94 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by Bristol-Myers Squibb · Observational
This is an observational, multicenter study in participants treated with nivolumab for the approved indications of melanoma and Lung cancer in Australia, the EU, Switzerland, the United Kingdom (UK), and the United States (US). The targeted countries in the EU for study participation include Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, and Spain. 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.
3,005 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's enrollment of 1,189 is above the median of 182 across 438 observational studies indexed under Melanoma.
Browse Melanoma studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population consists of 417 adults treated with nivolumab for histologically or cytologically confirmed melanoma and 772 adults treated with nivolumab for histologically or cytologically confirmed lung cancer in accordance with the approved indications in Australia, the EU, Switzerland, the UK, and the US. The targeted countries in the EU for participant enrollment include Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, and Spain. Participants 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 participant's consent.
Exclusion Criteria:
The study encompasses a single arm design with 417 adults treated with nivolumab for histologically or cytologically confirmed melanoma and 772 adults treated with nivolumab for histologically or cytologically confirmed lung cancer.
Incidence rate of and severity of immune-related pneumonitis - Melanoma
Time frame: up to nine years
Incidence rate of and severity of immune-related colitis- Melanoma
Time frame: up to nine years
Incidence rate of and severity of immune-related hepatitis - Melanoma
Time frame: up to nine years
Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma
Time frame: up to nine years
Incidence rate of and severity of immune-related endocrinopathies - Melanoma
Time frame: up to nine years
Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma
Time frame: up to nine years
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
Incidence rate of and severity of severe infusion reactions- Melanoma
Time frame: up to nine years
Incidence rate of and severity of immune-related pneumonitis - Lung Cancer
Time frame: up to nine years
Incidence rate of and severity of immune-related colitis - Lung Cancer
Time frame: up to nine years
Incidence rate of and severity of immune-related hepatitis - Lung Cancer
Time frame: up to nine years
Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer
Time frame: up to nine years
Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer
Time frame: up to nine years
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
Incidence rate of and severity of severe infusion reactions - Lung Cancer
Time frame: up to nine years
Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer
Time frame: up to nine years
Adverse Events
Other nivolumab treatment-related AEs
Time frame: Up to nine years
Management of Immune-related AEs:
Time frame: Up to nine years
Outcomes of Immune-related AEs:
Time frame: Up to nine years
Overall Survival:
1-, 2-, 3-, 4-, and 5-year overall and median survival
Time frame: Up to nine years
Nivolumab treatment pattern
Time frame: Up to nine years
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb