Status:
COMPLETED
A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Brief 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 da...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 11 2023
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT05432622
Start Date
December 19 2019
End Date
July 11 2023
Last Update
January 18 2024
Active Locations (1)
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1
Local Institution
The Woodlands, Texas, United States, 77380