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

Completed

• Conditions: Melanoma
• Interventions: Drug: Pemprolizumab

• Registration Number: NCT02600169
• Lead Sponsor: University Medical Center Groningen

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

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with pemprolizumab	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.

Primary Outcome Measures

Name	Time	Method
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
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.

Secondary Outcome Measures

Name	Time	Method
Survival	2 years	Overall survival will be evaluated for all patients treated with pembrolizumab.

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands