Clinical trial · Observational
A Study to Evaluate Treatment With Nivolumab Alone and Nivolumab Combined With Ipilimumab in Children With Melanoma
Real-World Evaluation of Patient Characteristics, Treatment Patterns, Safety, and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab for Pediatric 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)
The purpose of this study is to describe real-world safety outcomes in children with melanoma who are treated with nivolumab alone or nivolumab in combination with ipilimumab for unresectable or metastatic melanoma, or treated with adjuvant nivolumab after resection of stage IIB-IV melanoma. Demographic and clinical characteristics, and treatment patterns, will also be described in this population.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
| Nivolumab +/- ipilimumab | Drug | Ipilimumab/Nivolumab Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Participants treated with nivolumab +/- ipilimumab for unresectable/metastatic melanoma
- interventionNames
- Drug: Nivolumab +/- ipilimumab
- label
- Participants treated with nivolumab as adjuvant therapy for resected stage IIB-IV melanoma
- interventionNames
- Drug: Nivolumab
Primary outcomes (2)
- measure
- Incidence of treatment-related adverse events
- timeFrame
- Up to 100 days after treatment discontinuation
- measure
- Incidence of all-cause adverse events
- timeFrame
- Up to 100 days after treatment discontinuation
Secondary outcomes (39)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with confirmed diagnosis of unresectable or metastatic cutaneous melanoma, or stage IIB-IV cutaneous melanoma who have undergone complete resection * Initiated treatment with nivolumab monotherapy or in combination with ipilimumab for unresectable or metastatic melanoma, or as adjuvant therapy for resected stage IIb-IV melanoma, between January 1, 2015 and 6 months prior to data collection * For the adjuvant nivolumab cohort, initiated treatment with nivolumab for stage IIb-IV melanoma within 12 weeks following index resection * Aged \<18 years at the time of nivolumab/ipilimumab treatment initiation * At least 6 months of follow-up from index treatment date (unless deceased prior to end of 6 months) Exclusion Criteria: * Prior malignancy active within 3 years prior to nivolumab or ipilimumab treatment index date except for locally curable cancers that have been apparently cured (such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast) * Receiving nivolumab therapy (monotherapy, combination with ipilimumab, or adjuvant therapy) for melanoma as part of a clinical trial during the study period
References
Publications (0)
Data not yet available