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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02600169

Enrollment

150

Registered

2015-11-09

Start date

2015-07-31

Completion date

2019-04-30

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Brief summary

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.

Detailed description

Interventions

DRUGPemprolizumab

All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All patients that were eligible for treatment with pembrolizumab in the Named Patient Program in the Netherlands.

Design outcomes

Primary

Measure	Time frame	Description
Early serum response markers	up to day 126	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.
Predicitve patient characteristics	baseline	Patient characteristics: age, gender, WHO performance status
Predictive tumor characteristics	baseline	Tumor characteristics: M-stage, presence of CNS metastases, mutation status, PD-L1 status.
Adverse events of clinical interest will be collected and graded according to the CTCAE version 4.0 criteria	2 years	—

Secondary

Measure	Time frame	Description
Survival	2 years	Overall survival will be evaluated for all patients treated with pembrolizumab.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026