A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Treatment Patterns and Outcomes for Patients With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy in the US Community Oncology Setting

Conditions
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Melanoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nivolumab Monotherapy<br>Participants who started adjuvant nivolumab | |
| Pembrolizumab Monotherapy<br>Participants who started adjuvant pembrolizumab | |
| Dabrafenib + Trametinib Combination Therapy<br>Participants who started adjuvant dabrafenib + trametinib combination therapy | |
| No Treatment of a Systemic Therapy<br>Participants with no systemic treatment during the study observation period until record of recurrence | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Treatment Discontinuation (TTD) |  | Up to 39 Months | 
| Recurrence-free Survival (RFS) |  | Up to 39 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Treatment-related Adverse Events (AEs) |  | Up to 39 Months | 
| Time to Next Treatment (TTNT) |  | Up to 39 Months | 
| Number of Participants with Treatment-Related Hospitalizations |  | Up to 39 Months | 
| Number of Participants with Emergency Department Visits |  | Up to 39 Months | 
| Overall Survival (OS) |  | Up to 39 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-programmed cell death protein 1 (PD-1), Watchful waiting