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

Completed

• Conditions: Melanoma; Lung Cancer

• Registration Number: NCT02847728
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-07-25
• Study Start: 2016-07-28
• Study First Posted: 2016-07-28
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1189

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma	up to nine years
Incidence rate of and severity of immune-related hepatitis - Lung Cancer	up to nine years
Incidence rate of and severity of severe infusion reactions - Lung Cancer	up to nine years
Incidence rate of and severity of immune-related pneumonitis - Melanoma	up to nine years
Incidence rate of and severity of immune-related pneumonitis - Lung Cancer	up to nine years
Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer	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	up to nine years
Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma	up to nine years
Incidence rate of and severity of immune-related endocrinopathies - Melanoma	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	up to nine years
Incidence rate of and severity of immune-related colitis - Lung Cancer	up to nine years
Incidence rate of and severity of immune-related colitis- Melanoma	up to nine years
Incidence rate of and severity of immune-related hepatitis - Melanoma	up to nine years
Incidence rate of and severity of severe infusion reactions- Melanoma	up to nine years
Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer	up to nine years
Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer	up to nine years

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Up to nine years	Other nivolumab treatment-related AEs
Outcomes of Immune-related AEs:	Up to nine years
Management of Immune-related AEs:	Up to nine years
Overall Survival:	Up to nine years	1-, 2-, 3-, 4-, and 5-year overall and median survival
Nivolumab treatment pattern	Up to nine years

Trial Locations

Locations (94)

Local Institution - 1909; 🇺🇸 Palm Springs, California, United States

Local Institution - 1912; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 1907; 🇺🇸 Lake City, Florida, United States

Local Institution - 1901; 🇺🇸 Park Ridge, Illinois, United States

Local Institution - 1910; 🇺🇸 Alexandria, Louisiana, United States

Local Institution - 1906; 🇺🇸 Tupelo, Mississippi, United States

Local Institution - 1908; 🇺🇸 Kansas City, Missouri, United States

Local Institution - 1911; 🇺🇸 Morristown, New Jersey, United States

Local Institution - 1902; 🇺🇸 Bethlehem, Pennsylvania, United States

Local Institution - 1913; 🇺🇸 Hilton Head Island, South Carolina, United States

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