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Completed

NCT Number: NCT05426239

Treatment Patterns and Outcomes in Participants With Advanced Melanoma in Germany Using a German Database

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).

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Key information

Conditions

Advanced Melanoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site0001

Frankfurt, 60549, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS)

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

Secondary outcomes

  1. Progression-Free Survival (PFS)

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

  2. Objective Response Rate (ORR)

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

  3. Duration of Response (DOR)

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

  4. Treatment-free Interval (TFI)

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

  5. Treatment-free Survival (TFS)

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

  6. Incidence Rate (IR) of Adverse Drug Responses (ADRs)

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

  7. Resolution Rate (RR) of ADRs

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

  8. Frequency of ADRs

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

  9. Time to Treatment Discontinuation

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2022
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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