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

June 16, 2022 updated by: Bristol-Myers Squibb

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1008

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60549
        • Site0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Cohort 1
Participants initiating first-line systemic therapy to treat advanced melanoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to a maximum of 4 years of follow-up
Up to a maximum of 4 years of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to a maximum of 4 years of follow-up
Up to a maximum of 4 years of follow-up
Objective Response Rate (ORR)
Time Frame: Up to a maximum of 4 years of follow-up
Up to a maximum of 4 years of follow-up
Duration of Response (DOR)
Time Frame: Up to a maximum of 4 years of follow-up
Up to a maximum of 4 years of follow-up
Treatment-free Interval (TFI)
Time Frame: Up to a maximum of 4 years of follow-up
Up to a maximum of 4 years of follow-up
Treatment-free Survival (TFS)
Time Frame: Up to a maximum of 4 years of follow-up
Up to a maximum of 4 years of follow-up
Incidence Rate (IR) of Adverse Drug Responses (ADRs)
Time Frame: Up to a maximum of 4 years of follow-up
Up to a maximum of 4 years of follow-up
Resolution Rate (RR) of ADRs
Time Frame: Up to a maximum of 4 years of follow-up
Up to a maximum of 4 years of follow-up
Frequency of ADRs
Time Frame: Up to a maximum of 4 years of follow-up
Up to a maximum of 4 years of follow-up
Time to Treatment Discontinuation
Time Frame: Up to a maximum of 4 years of follow-up
Up to a maximum of 4 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2019

Primary Completion (Actual)

September 7, 2020

Study Completion (Actual)

September 7, 2020

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 16, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-8XH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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