An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in Australia

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma in Australia

Conditions
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Melanoma

Intervention / Treatment
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* Drug: nivolumab


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Adults with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete surgical removal and have no evidence of disease Decision to treat with adjuvant nivolumab therapy has already been taken Ability to provide written informed consent to participate in the study Exclusion Criteria: Adults with a current diagnosis of persisting advanced melanoma Adults currently enrolled in an interventional clinical trial for his/her melanoma treatment Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adjuvant nivolumab therapy<br>Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia | Drug: nivolumab<br>* Administered as adjuvant therapy as per the market authorization in Australia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 5 years post treatment initiation with adjuvant nivolumab therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Distant Metastasis-Free Survival (DMFS) |  | Up to 5 years post treatment initiation with adjuvant nivolumab therapy | 
| Overall Survival (OS) |  | Up to 5 years post treatment initiation with adjuvant nivolumab therapy | 
| Description of sociodemographic profile of participants |  | At treatment initiation with adjuvant nivolumab therapy | 
| Description of clinical characteristics of participants |  | At treatment initiation with adjuvant nivolumab therapy | 
| Prior medical history of participants |  | At treatment initiation with adjuvant nivolumab therapy | 
| Description of nivolumab pattern of use |  | 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) |  | 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) |  | 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 |  | Up to 5 years post treatment initiation with adjuvant nivolumab therapy | 
| Participants' socioeconomic status as assessed by their highest education level |  | At treatment initiation with adjuvant nivolumab therapy | 
| Description of care received as assessed by Healthcare Resource Utlization |  | During, and up to 5 years post discontinuation of nivolumab use | 
| Number of participants experiencing immune-related Adverse Events (AEs) |  | Up to 5 years post treatment initiation with adjuvant nivolumab therapy | 
| Number of participants experiencing non-immune-related AEs |  | Up to 5 years post treatment initiation with adjuvant nivolumab therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adjuvant, nivolumab