Treatment Patterns and Outcomes in Participants With Adva... | NCT05426239

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

NCT05426239

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jun 21, 2022Actual

Enrollment

1,008Actual

Phase

Not provided

Conditions

Advanced Melanoma

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 9, 2019Actual

Primary Completion Date

Sep 7, 2020Actual

Completion Date

Sep 7, 2020Actual

First Submitted Date

Jun 16, 2022

First Submission Date that Met QC Criteria

Jun 16, 2022

First Posted Date

Jun 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2022

Last Update Posted Date

Jun 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,008Actual

Label	Type	Description	Intervention Names
Cohort 1		Participants initiating first-line systemic therapy to treat advanced melanoma.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS)		Up to a maximum of 4 years of follow-up
Objective Response Rate (ORR)		Up to a maximum of 4 years of follow-up
Duration of Response (DOR)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site0001		Frankfurt		60549	Germany

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
Investigator Inquiry Form	View source
FDA Safety Alerts and Recalls