Advanced Melanoma
Conditions
Brief summary
This study is a non-interventional retrospective observational study performed on secondary data from a German multi-site cohort registry, the German national registry of skin cancer (ADOReg).
Interventions
None listed
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
* Signed informed consent for inclusion in ADOReg registry must be documented at study site * Diagnosis of advanced (nonresectable or metastatic) melanoma in stage III or stage IV * Participants received any systemic therapy to treat the advanced melanoma * First-line systemic treatment was initiated within the index window (19-Jun-2015 to 30-Jun-2018)
Exclusion criteria
* Age \<18 years at index date * Receipt of clinical trial study drug at any time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Up to a maximum of 4 years of follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | Up to a maximum of 4 years of follow-up |
| Duration of Response (DOR) | Up to a maximum of 4 years of follow-up |
| Treatment-free Interval (TFI) | Up to a maximum of 4 years of follow-up |
| Treatment-free Survival (TFS) | Up to a maximum of 4 years of follow-up |
| Progression-Free Survival (PFS) | Up to a maximum of 4 years of follow-up |
| Resolution Rate (RR) of ADRs | Up to a maximum of 4 years of follow-up |
| Frequency of ADRs | Up to a maximum of 4 years of follow-up |
| Time to Treatment Discontinuation | Up to a maximum of 4 years of follow-up |
| Incidence Rate (IR) of Adverse Drug Responses (ADRs) | Up to a maximum of 4 years of follow-up |
Countries
Germany
Outcome results
None listed