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NCT05426239 Clinical Trial

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

Advanced Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05426239
Other study ID # CA209-8XH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 9, 2019
Est. completion date September 7, 2020

Study information
Verified date June 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 1008
Est. completion date September 7, 2020
Est. primary completion date September 7, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Site0001 Frankfurt

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) Up to a maximum of 4 years of follow-up
Secondary Progression-Free Survival (PFS) Up to a maximum of 4 years of follow-up
Secondary Objective Response Rate (ORR) Up to a maximum of 4 years of follow-up
Secondary Duration of Response (DOR) Up to a maximum of 4 years of follow-up
Secondary Treatment-free Interval (TFI) Up to a maximum of 4 years of follow-up
Secondary Treatment-free Survival (TFS) Up to a maximum of 4 years of follow-up
Secondary Incidence Rate (IR) of Adverse Drug Responses (ADRs) Up to a maximum of 4 years of follow-up
Secondary Resolution Rate (RR) of ADRs Up to a maximum of 4 years of follow-up
Secondary Frequency of ADRs Up to a maximum of 4 years of follow-up
Secondary Time to Treatment Discontinuation Up to a maximum of 4 years of follow-up
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Recruiting NCT04640545 - A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma Phase 1
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