Advanced Melanoma Clinical Trial
Official title:
Treatment Patterns and Outcomes in Patients With Advanced Melanoma: A Retrospective Study Using Data From the German ADOREG Registry
| NCT number | NCT05426239 |
| Other study ID # | CA209-8XH |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 9, 2019 |
| Est. completion date | September 7, 2020 |
| Verified date | June 2022 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 1008 |
| Est. completion date | September 7, 2020 |
| Est. primary completion date | September 7, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Site0001 | Frankfurt |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) | Up to a maximum of 4 years of follow-up | ||
| Secondary | Progression-Free Survival (PFS) | Up to a maximum of 4 years of follow-up | ||
| Secondary | Objective Response Rate (ORR) | Up to a maximum of 4 years of follow-up | ||
| Secondary | Duration of Response (DOR) | Up to a maximum of 4 years of follow-up | ||
| Secondary | Treatment-free Interval (TFI) | Up to a maximum of 4 years of follow-up | ||
| Secondary | Treatment-free Survival (TFS) | Up to a maximum of 4 years of follow-up | ||
| Secondary | Incidence Rate (IR) of Adverse Drug Responses (ADRs) | Up to a maximum of 4 years of follow-up | ||
| Secondary | Resolution Rate (RR) of ADRs | Up to a maximum of 4 years of follow-up | ||
| Secondary | Frequency of ADRs | Up to a maximum of 4 years of follow-up | ||
| Secondary | Time to Treatment Discontinuation | Up to a maximum of 4 years of follow-up |
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