Clinical trial · Observational
A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy
Treatment Patterns and Outcomes for Patients With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy in the US Community Oncology Setting
NCT05432622CI-TRIAL-00073064completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- Nivolumab Monotherapy
- description
- Participants who started adjuvant nivolumab
- label
- Pembrolizumab Monotherapy
- description
- Participants who started adjuvant pembrolizumab
- label
- Dabrafenib + Trametinib Combination Therapy
- description
- Participants who started adjuvant dabrafenib + trametinib combination therapy
- label
- No Treatment of a Systemic Therapy
- description
- Participants with no systemic treatment during the study observation period until record of recurrence
Primary outcomes (2)
- measure
- Time to Treatment Discontinuation (TTD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.