The Effectiveness of Nivolumab Monotherapy as First-Line Therapy in Adults With Advanced Melanoma in Germany
- Conditions
- Melanoma
- Interventions
- Other: Non-Interventional
- Registration Number
- NCT03205722
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Melanoma patients with 1st-line Nivo treatment Non-Interventional Non-Interventional. Patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Approximately 23 months 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.
- Secondary Outcome Measures
Name Time Method 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 Approximately 23 months Socio-demographic characteristics (Gender, Height, Weight, Age) will be summarized using descriptive statistics
Distribution of clinical characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy Approximately 23 months Clinical characteristics (Initial Diagnosis of melanoma, Histological subtypes, Performance status, Comorbidities, history of cancer) will be summarized using descriptive statistics
Distribution of Treatment Patterns Approximately 23 months Details on Prior and Evolution of Current Treatment Patterns will be summarized using descriptive statistics.
Distribution of Healthcare Resource Utilization Approximately 23 months Healthcare Resource Utilization will be summarized using descriptive statistics
Duration of nivolumab treatment 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 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