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

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ClinicalTrials.gov Identifier: NCT05426239
Recruitment Status : Completed
First Posted : June 21, 2022
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Advanced Melanoma

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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 : January 9, 2019
Actual Primary Completion Date : September 7, 2020
Actual Study Completion Date : September 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

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



Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to a maximum of 4 years of follow-up ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05426239


Locations
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Germany
Site0001
Frankfurt, Germany, 60549
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05426239    
Other Study ID Numbers: CA209-8XH
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas