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

NCT05714371 | Completed

• 1 other identifier: CTMT212AUS57
• Study Type: observational
• Target: 618
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Number of patients on first systemic adjuvant therapy with adverse avents (AEs)

  Up to approximately 5 years

Secondary Outcomes (5)

• 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

Study Arms (2)

Immunotherapy (IO)

Patients receiving IO

Drug: Nivolumab; Drug: Ipilimumab + nivolumab; Drug: Pembrolizumab

Targeted therapy (TT)

Patients receiving TT

Drug: Dabrafenib + trametinib

Interventions

Nivolumab DRUG

Patients receiving nivolumab

Immunotherapy (IO)

Ipilimumab + nivolumab DRUG

Patients receiving ipilimumab + nivolumab

Immunotherapy (IO)

Pembrolizumab DRUG

Patients receiving pembrolizumab

Immunotherapy (IO)

Dabrafenib + trametinib DRUG

Dabrafenib + trametinib

Targeted therapy (TT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

• Patients with at least one diagnosis of malignant melanoma of skin anytime from the start of data collection until the start of study period.
• Patients with a procedure of first lymph node dissection or nodal basin ultrasound surveillance, per the National Comprehensive Cancer Network (NCCN) guidelines version 2.2020. The first lymph node dissection / nodal basin ultrasound surveillance signified that the patient was eligible to receive systemic treatment as adjuvant therapy.
• The first lymph node dissection or nodal basin ultrasound surveillance (index adjuvant date) must have had a diagnosis of malignant melanoma of skin within 6 months, to ensure that the dissection was related to melanoma.
• Patients with at least pharmacy or medical claim for the study drugs within 1 year on and after index date. The index date was the date of first prescription of study drug, IO (i.e., nivolumab, ipilimumab + nivolumab, pembrolizumab) or dabrafenib + trametinib.
• At least 18 years of age at the time of adjuvant treatment initiation.
• Patients with at least 6 months of continuous enrollment prior to the index date.
• Patients with at least 6 months of continuous enrollment after the index date.
• If necessary, there were additional criteria of absence of secondary malignancy (including metastatic site).

You may not qualify if:

• Patients with a diagnosis of non-melanoma primary malignancy during the 6 months pre-index period.
• Patients with chemotherapy or interferon alpha before index date.
• Patients with pregnancy any time during the study period.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab; Ipilimumab; pembrolizumab; dabrafenib; trametinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: October 2, 2021
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-01

Locations

US (1)