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An observational study of melanoma participants who are eligible for and who have initiated treatment with adjuvant nivolumab as part of routine clinical practice.
Participants receiving adjuvant nivolumab therapy could be enrolled prospectively and retrospectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants who initiate adjuvant treatment with nivolumab |
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| Measure | Description | Time Frame |
|---|---|---|
| RFS (relapse free survival) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| DMFS (distant metastasis free survival) | 5 years | |
| OS (overall survival) | 5 years | |
| Distribution of sociodemographic characteristics in participants initiating nivolumab |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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Adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection, and who receive adjuvant nivolumab under real-world conditions in Belgium or Luxembourg. Patients will be enrolled after complete surgical resection and following a screen procedure (according to standard practice) that shows no evidence of disease. Patients currently enrolled in an interventional clinical trial will not be eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Brussels | Brussels Capital | 1090 | Belgium | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| 5 years |
| Distribution of clinical characteristics in participants initiating nivolumab | 5 years |
| Distribution of treatment patterns in participants initiating nivolumab | 5 years |
| QOL (quality of life) of patients with resected melanoma receiving adjuvant nivolumab therapy by using the EuroQOL-5D (EQ-5D) | The EQ-5D is a standardized 3-level, 5-dimensional multi-attribute utility questionnaire that measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression, where each dimension is rated by individuals as no problems, slight problems, moderate problems, severe problems, and extreme problems. | 5 years |
| The European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire | The EORTC-QLQ-C30 questionnaire is a 30-item instrument that comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). | 5 years |
| Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaires | The FACT-M is a frequently used melanoma specific questionnaire which has been validated to assess HRQOL for patients with all stages of melanoma. Besides general questions on Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being, it also contains specific questions related to melanoma, including a subscale on the melanoma surgery | 5 years |
| Incidence of AE's | 5 years |
| Incidence of SAE's | 5 years |
| Aalst |
| 9300 |
| Belgium |
| Local Institution | Antwerp | 2020 | Belgium |
| Local Institution | Bouge | 5004 | Belgium |
| Local Institution | Bruges | B-8000 | Belgium |
| Local Institution | Brussels | 1000 | Belgium |
| Local Institution - 0014 | Edegem | 2650 | Belgium |
| Local Institution | Ghent | 9000 | Belgium |
| Local Institution | Hasselt | 3500 | Belgium |
| Local Institution | La Louvière | 7100 | Belgium |
| Local Institution - 0008 | Liège | 4000 | Belgium |
| Local Institution | Sint-Niklaas | 9100 | Belgium |
| Local Institution | Turnhout | 2300 | Belgium |
| Local Institution | Luxembourg | 1210 | Luxembourg |
| 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 |