NCT05432622
Completed
Not Applicable
Treatment Patterns and Outcomes for Patients With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy in the US Community Oncology Setting
ConditionsMelanoma
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Recurrence-free Survival (RFS)
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Recurrence-free Survival (RFS)
Time Frame: Up to 39 Months
Time to Treatment Discontinuation (TTD)
Time Frame: Up to 39 Months
Secondary Outcomes
- Number of Participants with Emergency Department Visits(Up to 39 Months)
- Number of Participants with Treatment-related Adverse Events (AEs)(Up to 39 Months)
- Number of Participants with Treatment-Related Hospitalizations(Up to 39 Months)
- Time to Next Treatment (TTNT)(Up to 39 Months)
- Overall Survival (OS)(Up to 39 Months)
Investigators
Study Sites (1)
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