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Clinical Trials/NCT05426239
NCT05426239
Completed
Not Applicable

Treatment Patterns and Outcomes in Patients With Advanced Melanoma: A Retrospective Study Using Data From the German ADOREG Registry

Bristol-Myers Squibb1 site in 1 country1,008 target enrollmentJanuary 9, 2019
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ConditionsAdvanced Melanoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Advanced Melanoma
Sponsor
Bristol-Myers Squibb
Enrollment
1008
Locations
1
Primary Endpoint
Overall Survival (OS)
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 9, 2019
End Date
September 7, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Overall Survival (OS)

Time Frame: Up to a maximum of 4 years of follow-up

Secondary Outcomes

  • 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)

Study Sites (1)

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