This study is designed to estimate the effectiveness of nivolumab when given to participants after removing their cancer with surgery, over a 5-year follow-up, in real-world conditions in Australia.
Study Type
OBSERVATIONAL
Enrollment
150
Administered as adjuvant therapy as per the market authorization in Australia
Local Institution
Garran, Australian Capital Territory, Australia
Local Institution
Birtinya, Queensland, Australia
Local Institution
Cairns, Queensland, Australia
Local Institution
Greenslopes, Queensland, Australia
Percentage of Participants with Relapse-Free Survival (RFS)
The time between the date of randomisation and the date of first recurrence, new primary melanoma, or death due to any cause, whichever occurred first.
Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Percentage of Participants with Distant Metastasis-Free Survival (DMFS)
Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Overall Survival (OS)
Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Description of sociodemographic profile of participants
Time frame: At treatment initiation with adjuvant nivolumab therapy
Description of clinical characteristics of participants
Time frame: At treatment initiation with adjuvant nivolumab therapy
Prior medical history of participants
Time frame: At treatment initiation with adjuvant nivolumab therapy
Description of nivolumab pattern of use
Time frame: At treatment initiation with adjuvant nivolumab therapy
Health-related quality of life (HRQOL) of participants as assessed by European Quality of Life Five Dimensional Scale (EuroQOL-5D/EQ-5D)
Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
HRQOL of participants as assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ C-30)
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Local Institution
Herston, Queensland, Australia
Local Institution
Woolloongabba, Queensland, Australia
Local Institution - 0006
Woodville South, South Australia, Australia
Local Institution
Box Hill, Victoria, Australia
Local Institution
Malvern, Victoria, Australia
Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
HRQOL of participants as assessed by Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire
Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Participants' socioeconomic status as assessed by their highest education level
Time frame: At treatment initiation with adjuvant nivolumab therapy
Description of care received as assessed by Healthcare Resource Utlization
Time frame: During, and up to 5 years post discontinuation of nivolumab use
Number of participants experiencing immune-related Adverse Events (AEs)
Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Number of participants experiencing non-immune-related AEs
Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy