Retrospective Analysis of Response Markers and Adverse Events in Melanoma Patients Treated With Pembrolizumab
May 3, 2024 updated by: University Medical Center Groningen
Retrospective Analysis of Response Markers and Adverse Events in a Nationwide Cohort of Advanced Melanoma Patients Treated With Pembrolizumab
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 Overview
Detailed 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.
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Groningen, Netherlands, 9713 GZ
- University Medical Center Groningen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma.
Description
All patients that were eligible for treatment with pembrolizumab in the Named Patient Program in the Netherlands.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients treated with pemprolizumab
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.
|
All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Early serum response markers
Time Frame: 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.
|
up to day 126
|
|
Predicitve patient characteristics
Time Frame: baseline
|
Patient characteristics: age, gender, WHO performance status
|
baseline
|
|
Predictive tumor characteristics
Time Frame: baseline
|
Tumor characteristics: M-stage, presence of CNS metastases, mutation status, PD-L1 status.
|
baseline
|
|
Adverse events of clinical interest will be collected and graded according to the CTCAE version 4.0 criteria
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival
Time Frame: 2 years
|
Overall survival will be evaluated for all patients treated with pembrolizumab.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: G.A.P. Hospers, MD, PhD, University Medical Center Groningen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2015
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
April 1, 2019
Study Registration Dates
First Submitted
November 3, 2015
First Submitted That Met QC Criteria
November 6, 2015
First Posted (Estimated)
November 9, 2015
Study Record Updates
Last Update Posted (Actual)
May 6, 2024
Last Update Submitted That Met QC Criteria
May 3, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20150907
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.