Melanoma
Conditions
Keywords
Anti-programmed cell death protein 1 (PD-1), Watchful waiting
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 data from the United States Oncology Network (USON) iKnowMed (iKM) electronic health records (EHR) database.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Treatment Discontinuation (TTD) | Up to 39 Months |
| Recurrence-free Survival (RFS) | Up to 39 Months |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-Related Hospitalizations | Up to 39 Months |
| Number of Participants with Treatment-related Adverse Events (AEs) | Up to 39 Months |
| Overall Survival (OS) | Up to 39 Months |
| Number of Participants with Emergency Department Visits | Up to 39 Months |
| Time to Next Treatment (TTNT) | Up to 39 Months |
Countries
United States
Outcome results
None listed