Advanced MelanomaNCT05426239
Treatment Patterns and Outcomes in Participants With Advanced Melanoma in Germany Using a German Database
An observational study of Advanced Melanoma, run by Bristol-Myers Squibb at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma
- How many people
- 1,008 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jan 2019to 7 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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)
Who may be able to join
- 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)
Who cannot join
- Age <18 years at index date
- Receipt of clinical trial study drug at any time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Advanced Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants initiating first-line systemic therapy to treat advanced melanoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: Up to a maximum of 4 years of follow-up
Secondary outcomes (9)
Progression-Free Survival (PFS)
Measured: Up to a maximum of 4 years of follow-up
Objective Response Rate (ORR)
Measured: Up to a maximum of 4 years of follow-up
Duration of Response (DOR)
Measured: Up to a maximum of 4 years of follow-up
Treatment-free Interval (TFI)
Measured: Up to a maximum of 4 years of follow-up
Treatment-free Survival (TFS)
Measured: Up to a maximum of 4 years of follow-up
Incidence Rate (IR) of Adverse Drug Responses (ADRs)
Measured: Up to a maximum of 4 years of follow-up
Resolution Rate (RR) of ADRs
Measured: Up to a maximum of 4 years of follow-up
Frequency of ADRs
Measured: Up to a maximum of 4 years of follow-up
Time to Treatment Discontinuation
Measured: Up to a maximum of 4 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start9 Jan 2019
- Primary completion7 Sep 2020
- Study completion7 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426239
- Sponsor's protocol ID
- CA209-8XH
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Outcomes in Patients With Advanced Melanoma: A Retrospective Study Using Data From the German ADOREG Registry
- ClinicalTrials.gov ID
- NCT05426239
- Acronym / sponsor ID
- CA209-8XH
- Conditions
- Advanced Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,008 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 7 Sep 2020 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants initiating first-line systemic therapy to treat advanced melanoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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)
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Age <18 years at index date
- Receipt of clinical trial study drug at any time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: Up to a maximum of 4 years of follow-up
9 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 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
Duration of Response (DOR)
Time frame: 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
Treatment-free Survival (TFS)
Time frame: 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
Resolution Rate (RR) of ADRs
Time frame: 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
Time to Treatment Discontinuation
Time frame: Up to a maximum of 4 years of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Melanoma, run by Bristol-Myers Squibb at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to a maximum of 4 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.