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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Melanoma

Study type: Observational

Funder types: Industry

Identifiers

NCT05432622

CA209-7PG

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

95 participants in 4 patient groups

Nivolumab Monotherapy

Description:

Participants who started adjuvant nivolumab

Pembrolizumab Monotherapy

Description:

Participants who started adjuvant pembrolizumab

Dabrafenib + Trametinib Combination Therapy

Description:

Participants who started adjuvant dabrafenib + trametinib combination therapy

No Treatment of a Systemic Therapy

Description:

Participants with no systemic treatment during the study observation period until record of recurrence