A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy
NCT ID: NCT05432622
Last Updated: 2024-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
95 participants
OBSERVATIONAL
2019-12-19
2023-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Nivolumab Monotherapy
Participants who started adjuvant nivolumab
No interventions assigned to this group
Pembrolizumab Monotherapy
Participants who started adjuvant pembrolizumab
No interventions assigned to this group
Dabrafenib + Trametinib Combination Therapy
Participants who started adjuvant dabrafenib + trametinib combination therapy
No interventions assigned to this group
No Treatment of a Systemic Therapy
Participants with no systemic treatment during the study observation period until record of recurrence
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
The Woodlands, Texas, United States
Countries
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Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
Investigator Inquiry Form
Other Identifiers
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CA209-7PG
Identifier Type: -
Identifier Source: org_study_id
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