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

Completed

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT05432622

Run by

Bristol-Myers Squibb

People needed

95

Starts

2019-12-19

Expected to finish

2023-07-11

Last updated by the study team

2024-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.