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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT05426239
Collaborator
(none)
1,008
Enrollment
1
Location
19.9
Actual Duration (Months)
50.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1008 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Treatment Patterns and Outcomes in Patients With Advanced Melanoma: A Retrospective Study Using Data From the German ADOREG Registry
    Actual Study Start Date :
    Jan 9, 2019
    Actual Primary Completion Date :
    Sep 7, 2020
    Actual Study Completion Date :
    Sep 7, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort 1

    Participants initiating first-line systemic therapy to treat advanced melanoma.

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) [Up to a maximum of 4 years of follow-up]

    Secondary Outcome Measures

    1. Progression-Free Survival (PFS) [Up to a maximum of 4 years of follow-up]

    2. Objective Response Rate (ORR) [Up to a maximum of 4 years of follow-up]

    3. Duration of Response (DOR) [Up to a maximum of 4 years of follow-up]

    4. Treatment-free Interval (TFI) [Up to a maximum of 4 years of follow-up]

    5. Treatment-free Survival (TFS) [Up to a maximum of 4 years of follow-up]

    6. Incidence Rate (IR) of Adverse Drug Responses (ADRs) [Up to a maximum of 4 years of follow-up]

    7. Resolution Rate (RR) of ADRs [Up to a maximum of 4 years of follow-up]

    8. Frequency of ADRs [Up to a maximum of 4 years of follow-up]

    9. Time to Treatment Discontinuation [Up to a maximum of 4 years of follow-up]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site0001 Frankfurt Germany 60549

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05426239
    Other Study ID Numbers:
    • CA209-8XH
    First Posted:
    Jun 21, 2022
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Jun 21, 2022