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A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy | Clinical Trials | Clareo Health

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

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

NCT05432622•Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Local Institution

The Woodlands, Texas, United States

Key Dates

Start Date

December 19, 2019

Primary Completion Date

April 26, 2023

Completion Date

July 11, 2023

Last Updated

January 18, 2024

Enrollment

ACTUAL participants

Conditions

Melanoma

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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