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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05432622
• Other study ID #: CA209-7PG
• Status: Completed
• Start date: December 19, 2019
• Est. completion date: July 11, 2023

Study information

• Verified date: January 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: July 11, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
United States	Local Institution	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Treatment Discontinuation (TTD)		Up to 39 Months
Primary	Recurrence-free Survival (RFS)		Up to 39 Months
Secondary	Number of Participants with Treatment-related Adverse Events (AEs)		Up to 39 Months
Secondary	Time to Next Treatment (TTNT)		Up to 39 Months
Secondary	Number of Participants with Treatment-Related Hospitalizations		Up to 39 Months
Secondary	Number of Participants with Emergency Department Visits		Up to 39 Months
Secondary	Overall Survival (OS)		Up to 39 Months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form