The Effectiveness of Nivolumab Monotherapy as First-Line Therapy in Adults With Advanced Melanoma in Germany

Study Overview
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Brief Summary
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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.

Official Title
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The Effectiveness of Nivolumab (OPDIVO®) Monotherapy as First-Line Therapy in Adults With Advanced (Unresectable or Metastatic) Melanoma: An Early Retrospective, Observational Study in Germany

Conditions
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Melanoma

Intervention / Treatment
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* Other: Non-Interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with a primary diagnosis of advanced melanoma (histologically confirmed stage III [unresectable] or stage IV skin, ocular, or mucosal melanoma) Newly initiated with nivolumab monotherapy as their first-line therapy for previously untreated advanced melanoma between June 2015 and June 2016 At least 18 years of age at time of treatment decision Exclusion Criteria: Patients with a current primary diagnosis of a cancer other than advanced melanoma ie, a cancer other than melanoma that requires systemic or other treatment Patients currently included in an interventional clinical trial for his/her locally advanced or metastatic melanoma. Patients who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. In case of a blinded study, the treatment arm (ie, type of administered treatment) needs to be known. Patients < 18 years of age at time of treatment initiation Other protocol defined inclusion/exclusion criteria could 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 |
| --- | --- |
| Melanoma patients with 1st-line Nivo treatment<br>Non-Interventional. Patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016. | Other: Non-Interventional<br>* Non-Interventional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 |