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.
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.
Study Type
OBSERVATIONAL
Enrollment
150
All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma.
University Medical Center Groningen
Groningen, Netherlands
Early serum response markers
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.
Time frame: up to day 126
Predicitve patient characteristics
Patient characteristics: age, gender, WHO performance status
Time frame: baseline
Predictive tumor characteristics
Tumor characteristics: M-stage, presence of CNS metastases, mutation status, PD-L1 status.
Time frame: baseline
Adverse events of clinical interest will be collected and graded according to the CTCAE version 4.0 criteria
Time frame: 2 years
Survival
Overall survival will be evaluated for all patients treated with pembrolizumab.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.