Clinical trial · Observational
Retrospective Analysis of Response Markers and Adverse Events in Melanoma Patients Treated With Pembrolizumab
Retrospective Analysis of Response Markers and Adverse Events in a Nationwide Cohort of Advanced Melanoma Patients Treated With Pembrolizumab
NCT02600169CI-TRIAL-00076819completedClinicalTrials.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)
This study is a retrospective cohort study. A database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the Netherlands. This database will be used for analysis of response markers and for an evaluation of adverse events.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemprolizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients treated with pemprolizumab
- description
- All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma. Patients will be included from all 14 WIN-O (Werkgroep Immunologie Nederland voor Oncologie) centers in the Netherlands. Patients are at least 18 years of age.
- interventionNames
- Drug: Pemprolizumab
Primary outcomes (4)
- measure
- Early serum response markers
- timeFrame
- up to day 126
- description
- Serum markers: S100B, LDH, white blood count differential neutrophils, monocytes, lymphocytes, eosinophils, basophils. Markers will be correlated to early response as measured by RECIST 1.1 criteria at week 12 and 18 of treatment with pembrolizumab.
- measure
- Predicitve patient characteristics
- timeFrame
- baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
All patients that were eligible for treatment with pembrolizumab in the Named Patient Program in the Netherlands.
References
Publications (0)
Data not yet available
No reference posted for this study.