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

NCT02600169 | Completed

• 1 other identifier: 20150907
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (4)

• 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

• Predicitve patient characteristics

  Patient characteristics: age, gender, WHO performance status

  baseline

• Predictive tumor characteristics

  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

  2 years

Secondary Outcomes (1)

• Survival

  2 years

Study Arms (1)

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.

Drug: Pemprolizumab

Interventions

Pemprolizumab DRUG

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

Also known as: MK3475

Patients treated with pemprolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• G.A.P. Hospers, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 9, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

NL (1)