MelanomaNCT05432622
A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to examine real-world data among participants with stage IIIa melanoma initiating nivolumab as adjuvant treatment in the community practice setting by utilizing patient data from the United States Oncology Network (USON) iKnowMed (iKM) electronic health records (EHR) database. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 11 Jul 2023
- 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: Adult participants diagnosed with stage IIIA melanoma receiving an adjuvant systemic treatment regimen in the USON iKM EHR database were identified.
Who may be able to join
- Participants diagnosed with Stage IIIA melanoma during identification period
- Participants underwent sentinel lymph node biopsy (SLNB) (index-event) during identification period
- Participants with a complete surgical resection at or following SLNB during the identification period
- Participants received nivolumab, pembrolizumab or dabrafenib/trametinib as adjuvant therapy in USON post-index event during the identification period (i.e., within 12 weeks of SLNB/resection); or received no treatment during the index period
- Participants receiving care at a USON site utilizing the full EHR capacities of the iKM database at the time of treatment
- Participants with ≥2 visits within the USON during the observation period
- Participants ≥18 years of age at first clinical diagnosis of melanoma
Who cannot join
- Participants with a previous systemic therapy prior to index
- Participants with a diagnosis of ocular or uveal melanoma during the study period
- Participants with a previous nonmelanoma cancer without complete remission for more than 3 years prior to index
- Participants with mucosal or acral melanoma during the study period
- Participants with systemic use of glucocorticoids during at the initiation of adjuvant therapy
- Participants enrolled in a clinical trial at any time during the study period
- Participants with a diagnosis and receiving treatment for another malignancy during the study observation period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Patterns and Outcomes for Patients With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy in the US Community Oncology Setting
The purpose of this study is to examine real-world data among participants with stage IIIa melanoma initiating nivolumab as adjuvant treatment in the community practice setting by utilizing patient data from the United States Oncology Network (USON) iKnowMed (iKM) electronic health records (EHR) database.
- Conditions
- Melanoma
- Keywords
- Anti-programmed cell death protein 1 (PD-1), Watchful waiting
- Medical subject headings
- Melanoma, Parkinson Disease 4, Autosomal Dominant Lewy Body
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 |
|---|---|---|
| Nivolumab Monotherapy | Participants who started adjuvant nivolumab | |
| Pembrolizumab Monotherapy | Participants who started adjuvant pembrolizumab | |
| Dabrafenib + Trametinib Combination Therapy | Participants who started adjuvant dabrafenib + trametinib combination therapy | |
| No Treatment of a Systemic Therapy | Participants with no systemic treatment during the study observation period until record of recurrence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Treatment Discontinuation (TTD)
Measured: Up to 39 Months
Recurrence-free Survival (RFS)
Measured: Up to 39 Months
Secondary outcomes (5)
Number of Participants with Treatment-related Adverse Events (AEs)
Measured: Up to 39 Months
Time to Next Treatment (TTNT)
Measured: Up to 39 Months
Number of Participants with Treatment-Related Hospitalizations
Measured: Up to 39 Months
Number of Participants with Emergency Department Visits
Measured: Up to 39 Months
Overall Survival (OS)
Measured: Up to 39 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start19 Dec 2019
- Primary completion26 Apr 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 95 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
- NCT05432622
- Sponsor's protocol ID
- CA209-7PG
- Status last verified
- Jan 2024
- First submitted
- 21 Jun 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Outcomes for Patients With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy in the US Community Oncology Setting
- ClinicalTrials.gov ID
- NCT05432622
- Acronym / sponsor ID
- CA209-7PG
- Conditions
- Melanoma
- Keywords
- Anti-programmed cell death protein 1 (PD-1), Watchful waiting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 27 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.
The purpose of this study is to examine real-world data among participants with stage IIIa melanoma initiating nivolumab as adjuvant treatment in the community practice setting by utilizing patient data from the United States Oncology Network (USON) iKnowMed (iKM) electronic health records (EHR) database.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nivolumab Monotherapy | – | –Participants who started adjuvant nivolumab |
| Pembrolizumab Monotherapy | – | –Participants who started adjuvant pembrolizumab |
| Dabrafenib + Trametinib Combination Therapy | – | –Participants who started adjuvant dabrafenib + trametinib combination therapy |
| No Treatment of a Systemic Therapy | – | –Participants with no systemic treatment during the study observation period until record of recurrence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants diagnosed with stage IIIA melanoma receiving an adjuvant systemic treatment regimen in the USON iKM EHR database were identified.
Key inclusion criteria (7 listed)
- Participants diagnosed with Stage IIIA melanoma during identification period
- Participants underwent sentinel lymph node biopsy (SLNB) (index-event) during identification period
- Participants with a complete surgical resection at or following SLNB during the identification period
- Participants received nivolumab, pembrolizumab or dabrafenib/trametinib as adjuvant therapy in USON post-index event during the identification period (i.e., within 12 weeks of SLNB/resection); or received no treatment during the index period
- Participants receiving care at a USON site utilizing the full EHR capacities of the iKM database at the time of treatment
Key exclusion criteria (7 listed)
- Participants with a previous systemic therapy prior to index
- Participants with a diagnosis of ocular or uveal melanoma during the study period
- Participants with a previous nonmelanoma cancer without complete remission for more than 3 years prior to index
- Participants with mucosal or acral melanoma during the study period
- Participants with systemic use of glucocorticoids during at the initiation of adjuvant therapy
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
Time to Treatment Discontinuation (TTD)
Time frame: Up to 39 Months
Recurrence-free Survival (RFS)
Time frame: Up to 39 Months
5 secondary outcomes
Number of Participants with Treatment-related Adverse Events (AEs)
Time frame: Up to 39 Months
Time to Next Treatment (TTNT)
Time frame: Up to 39 Months
Number of Participants with Treatment-Related Hospitalizations
Time frame: Up to 39 Months
Number of Participants with Emergency Department Visits
Time frame: Up to 39 Months
Overall Survival (OS)
Time frame: Up to 39 Months
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 18 Jan 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Investigator Inquiry FormLink 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 Melanoma, run by Bristol-Myers Squibb at 1 site in United States.
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 7 inclusion and 7 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 18 Jan 2024. 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 United States. 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?
Time to Treatment Discontinuation (TTD) (time frame: Up to 39 Months). The study lists 2 primary outcomes in all. 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 18 Jan 2024.