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Completed

NCT Number: NCT05714371

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Nivolumab

Drug

Patients receiving nivolumab

Ipilimumab + nivolumab

Drug

Patients receiving ipilimumab + nivolumab

Pembrolizumab

Drug

Patients receiving pembrolizumab

Dabrafenib + Trametinib

Drug

Dabrafenib + trametinib

Primary outcomes

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

    Time frame: Up to approximately 5 years

Secondary outcomes

  1. Number of patients with AEs following first systemic adjuvant therapy completion/discontinuation.

    Time frame: Up to approximately 5 years

  2. Healthcare resource utilization (HCRU) associated with AEs on first systemic adjuvant therapy

    Time frame: Up to approximately 5 years

  3. Healthcare costs associated with AEs on first systemic adjuvant therapy

    Time frame: Up to approximately 5 years

  4. HCRU associated with AEs following first systemic adjuvant therapy completion/discontinuation

    Time frame: Up to approximately 5 years

  5. Healthcare costs associated with AEs following first systemic adjuvant therapy completion/discontinuation

    Time frame: Up to approximately 5 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2023
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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