Melanoma
Conditions
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.
Interventions
OTHERNon-Interventional
Non-Interventional
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| OS from date of advanced diagnosis | 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 | 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 | — |
| Distribution of Best Overall Response (BOR) by Melanoma subtype | Approximately 23 months | — |
Outcome results
None listed