Clinical trial NCT05432622: A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy
Official title: Treatment Patterns and Outcomes for Patients With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy in the US Community Oncology Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: Anti-programmed cell death protein 1 (PD-1)
Watchful waiting
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-06-27
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants diagnosed with stage IIIA melanoma receiving an adjuvant systemic treatment regimen in the USON iKM EHR database were identified.

Brief 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 criteria: 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

Primary outcomes:
measure: Time to Treatment Discontinuation (TTD)
timeFrame: Up to 39 Months
measure: Recurrence-free Survival (RFS)
timeFrame: Up to 39 Months
Secondary outcomes:
measure: Number of Participants with Treatment-related Adverse Events (AEs)
timeFrame: Up to 39 Months
measure: Time to Next Treatment (TTNT)
timeFrame: Up to 39 Months
measure: Number of Participants with Treatment-Related Hospitalizations
timeFrame: Up to 39 Months
measure: Number of Participants with Emergency Department Visits
timeFrame: Up to 39 Months
measure: Overall Survival (OS)
timeFrame: Up to 39 Months
Other outcomes:
Locations:
city: The Woodlands
country: United States
facility: Local Institution
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: