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CompletedNCT05426239Updated Jun 21, 2022

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

An observational study in Advanced Melanoma, sponsored by Bristol-Myers Squibb. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-21.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,008
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Advanced Melanoma

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03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 1,008 is above the median of 182 across 438 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All adult participants diagnosed with advanced melanoma in the ADOReg database. Participants were included based on the following:

  • a diagnosis of advanced (unresectable or metastasized) melanoma at stage III or IV according to American Joint Committee on Cancer or AJCC staging
  • Participants receive systemic therapy to treat the advanced melanoma
  • First-line treatment was initiated within the index window (19-Jun-2015 to 30-Jun-2018)

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

Exclusion Criteria:

  • Age \<18 years at index date
  • Receipt of clinical trial study drug at any time
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,008 participants (actual)
Patient registry
No

Groups and cohorts

  • Cohort 1

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

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What researchers measure

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

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Study locations

1 site
  • Site0001
    Frankfurt, 60549, Germany
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05426239
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Jun 21, 2022
Start date
Jan 9, 2019
Primary completion
Sep 7, 2020
Completion
Sep 7, 2020
Last update
Jun 21, 2022

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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