Clinical trial · Observational
Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dabrafenib + trametinib | Drug | Dabrafenib/Trametinib Regimen | ALIAS |
| Ipilimumab + nivolumab | Drug | Ipilimumab/Nivolumab Regimen | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Immunotherapy (IO)
- description
- Patients receiving IO
- interventionNames
- Drug: Nivolumab
- Drug: Ipilimumab + nivolumab
- Drug: Pembrolizumab
- label
- Targeted therapy (TT)
- description
- Patients receiving TT
- interventionNames
- Drug: Dabrafenib + trametinib
Primary outcomes (1)
- measure
- Number of patients on first systemic adjuvant therapy with adverse avents (AEs)
- timeFrame
- Up to approximately 5 years
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available