Treatment Patterns and Outcomes in Participants With Advanced Melanoma in Germany Using a German Database
Completed
- Conditions
- Advanced Melanoma
- Registration Number
- NCT05426239
- Lead Sponsor
- Bristol-Myers Squibb
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1008
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to a maximum of 4 years of follow-up
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Up to a maximum of 4 years of follow-up Treatment-free Survival (TFS) Up to a maximum of 4 years of follow-up Frequency of ADRs Up to a maximum of 4 years of follow-up Duration of Response (DOR) Up to a maximum of 4 years of follow-up Time to Treatment Discontinuation Up to a maximum of 4 years of follow-up Objective Response Rate (ORR) 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 Treatment-free Interval (TFI) 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
Trial Locations
- Locations (1)
Site0001
🇩🇪Frankfurt, Germany