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NCT Number: NCT02600169

Retrospective Analysis of Response Markers and Adverse Events in 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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemprolizumab

Drug

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

Other names: MK3475

Primary outcomes

  1. 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.

  2. Predicitve patient characteristics

    Time frame: baseline

    Patient characteristics: age, gender, WHO performance status

  3. Predictive tumor characteristics

    Time frame: baseline

    Tumor characteristics: M-stage, presence of CNS metastases, mutation status, PD-L1 status.

  4. Adverse events of clinical interest will be collected and graded according to the CTCAE version 4.0 criteria

    Time frame: 2 years

Secondary outcomes

  1. Survival

    Time frame: 2 years

    Overall survival will be evaluated for all patients treated with pembrolizumab.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2015
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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