Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma

Completed

• Conditions: Melanoma
• Interventions: Drug: Dabrafenib + trametinib; Drug: Nivolumab; Drug: Ipilimumab + nivolumab; Drug: Pembrolizumab

• Registration Number: NCT05714371
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This was a retrospective cohort study using the PharMetrics database. The analysis was conducted using the most recent 5 years of data from the database, January 1, 2015, to October 30, 2020. Included patients were followed for outcome evaluation from the index date (first prescription of treatment, immunotherapy \[IO\], or targeted therapy \[TT\] following diagnosis of non-metastatic malignant melanoma and evidence of first lymph node resection), until the first occurrence or end of continuous eligibility or end of the study period.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-02
• Primary Completion: 2022-01-27
• Study Completion: 2022-01-27
• Status Verified: 2023-01
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-01-27
• Last Update Submitted: 2023-01-27
• Study First Posted: 2023-02-06
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 618

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immunotherapy (IO)	Ipilimumab + nivolumab	Patients receiving IO
Targeted therapy (TT)	Dabrafenib + trametinib	Patients receiving TT
Immunotherapy (IO)	Nivolumab	Patients receiving IO
Immunotherapy (IO)	Pembrolizumab	Patients receiving IO

Primary Outcome Measures

Name	Time	Method
Number of patients on first systemic adjuvant therapy with adverse avents (AEs)	Up to approximately 5 years

Secondary Outcome Measures

Name	Time	Method
Number of patients with AEs following first systemic adjuvant therapy completion/discontinuation.	Up to approximately 5 years
Healthcare resource utilization (HCRU) associated with AEs on first systemic adjuvant therapy	Up to approximately 5 years
Healthcare costs associated with AEs on first systemic adjuvant therapy	Up to approximately 5 years
HCRU associated with AEs following first systemic adjuvant therapy completion/discontinuation	Up to approximately 5 years
Healthcare costs associated with AEs following first systemic adjuvant therapy completion/discontinuation	Up to approximately 5 years

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States