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Business objectives have changed
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A retrospective, observational study based on chart reviews for patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016, conducted in a representative sample of sites in Germany.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melanoma patients with 1st-line Nivo treatment | Non-Interventional. Patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | Non-Interventional |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab monotherapy as first-line therapy from date of advanced diagnosis, and from the start of treatment with nivolumab over the first 23 months after treatment initiation, overall. | Approximately 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS from date of advanced diagnosis | Approximately 23 months | |
| progression-free survival (PFS) | Approximately 23 months | |
| best overall response rate (BORR) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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all patients diagnosed with advanced melanoma who were initiated with nivolumab monotherapy as their first-line therapy in Germany between June 2015 and June 2016.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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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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| Approximately 23 months |
| best overall response (BOR) | Approximately 23 months |
| Distribution of Best Overall Response (BOR) by Severity of melanoma at initiation of treatment | Approximately 23 months |
| Best Overall Response (BOR) in patients greater than or equal to 65 years old | Approximately 23 months |
| Best Overall Response (BOR) in Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 2 | Approximately 23 months |
| Distribution of Best Overall Response (BOR) by Mutational status | Approximately 23 months |
| Best Overall Response (BOR) in Patients with brain metastases | Approximately 23 months |
| Distribution of Best Overall Response (BOR) by Melanoma subtype | Approximately 23 months |
| Distribution of incidence of Adverse Events (AEs) | Approximately 23 months |
| Distribution of severity of Adverse Events (AEs) | Approximately 23 months |
| Distribution of management of Adverse Events (AEs) | Approximately 23 months |
| Distribution of socio-demographic characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy | Socio-demographic characteristics (Gender, Height, Weight, Age) will be summarized using descriptive statistics | Approximately 23 months |
| Distribution of clinical characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy | Clinical characteristics (Initial Diagnosis of melanoma, Histological subtypes, Performance status, Comorbidities, history of cancer) will be summarized using descriptive statistics | Approximately 23 months |
| Distribution of Treatment Patterns | Details on Prior and Evolution of Current Treatment Patterns will be summarized using descriptive statistics. | Approximately 23 months |
| Distribution of Healthcare Resource Utilization | Healthcare Resource Utilization will be summarized using descriptive statistics | Approximately 23 months |
| Duration of nivolumab treatment | Approximately 23 months |
| 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 |