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NCT02600169 Clinical Trial

Retrospective Analysis of Response Markers and Adverse Events in Melanoma Patients Treated With Pembrolizumab

Melanoma Clinical Trial

Official title:
Retrospective Analysis of Response Markers and Adverse Events in a Nationwide Cohort of Advanced Melanoma Patients Treated With Pembrolizumab

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02600169
Other study ID # 20150907
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2015
Est. completion date April 2019

Study information
Verified date May 2024
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility All patients that were eligible for treatment with pembrolizumab in the Named Patient Program in the Netherlands.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)
Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. up to day 126
Primary Predicitve patient characteristics Patient characteristics: age, gender, WHO performance status baseline
Primary Predictive tumor characteristics Tumor characteristics: M-stage, presence of CNS metastases, mutation status, PD-L1 status. baseline
Primary Adverse events of clinical interest will be collected and graded according to the CTCAE version 4.0 criteria 2 years
Secondary Survival Overall survival will be evaluated for all patients treated with pembrolizumab. 2 years
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