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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant nivolumab therapy | Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nivolumab | Drug | Administered as adjuvant therapy as per the market authorization in Australia |
|
| 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 |
| 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 |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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Adults whose melanoma had spread to the lymph nodes or other parts of the body and was surgically removed, and who are receiving post-surgery treatment with nivolumab to decrease the risk of cancer coming back.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Garran | Australian Capital Territory | 2605 | Australia | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| 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 |
| Birtinya |
| Queensland |
| 4575 |
| Australia |
| Local Institution | Cairns | Queensland | 4870 | Australia |
| Local Institution | Greenslopes | Queensland | 4120 | Australia |
| Local Institution | Herston | Queensland | 4031 | Australia |
| Local Institution | Woolloongabba | Queensland | 4012 | Australia |
| Local Institution - 0006 | Woodville South | South Australia | 5001 | Australia |
| Local Institution | Box Hill | Victoria | 3128 | Australia |
| Local Institution | Malvern | Victoria | 3144 | Australia |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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