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Immune Monitoring in Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT04158544
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Edward Geissler, University of Regensburg

Brief Summary:

The mean survival time in the advanced tumor stage in the presence of distant metastases in malignant melanoma was less than 9 months until a few years ago. Intensive research efforts have led to the development of promising new therapeutic strategies and their clinical application. These include on the one hand mutation-specific inhibitors of important for cell division serine-threonine kinase BRAF such as vemurafenib, dabrafenib and encorafenib and inhibitors of the downstream target protein, the mitogen-activated protein kinase kinase (MEK), such as trametinib, binimetinib and cobimetinib.

The group of immunotherapeutics is a second new class of drugs, in which great hope for the treatment of metastatic melanoma is placed. Antibody-mediated blockage of surface molecules expressed on immune cells, referred to as immune checkpoints, results in activation of the immune system. As a result, an anti-tumor immune response is triggered, which has led to considerable therapeutic success in metastatic melanoma. To date, three checkpoint inhibitors have been approved for the treatment of metastatic melanoma. Ipilimumab is an antibody that binds cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4); Pembrolizumab and nivolumab cause immune stimulation by binding the Programmed Death Receptor (PD1).

However, the impact of the therapy on the immune system as a whole is largely unknown. A comprehensive understanding of these effects is crucial to be able to further develop the therapy and to evaluate useful combination therapies with other immunomodulatory agents.

Within the framework of this project changes of the immune response under a systemic therapy of the malignant melanoma are to be characterized. The material for the analysis comes from blood samples collected during routine patient check-ups.

The aim of the analyzes is to precisely characterize the effects of the different therapeutics on the function of the immune system. In particular, the study will investigate whether certain therapeutic agents can weaken or activate the immune system and thus, in addition to the direct effect on the tumor cells, mediate indirect therapeutic effects via immune modulation. In the long term, the investigators want to use the knowledge gained to further improve the already existing therapeutic strategies of malignant melanoma by additional modulation of the immune system.


Condition or disease
Metastatic Melanoma

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Monitoring During Systemic Therapy of Metastatic Malignant Melanoma
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Group/Cohort
Checkpoint Inhibitors
Patients with metastatic melanoma receiving systemic therapy with checkpoint inhibitors
Kinase Inhibitors
Patients with metastatic melanoma receiving systemic therapy with kinase inhibitors



Primary Outcome Measures :
  1. Change in frequency of peripheral immune cell populations assessed by immune monitoring through flow cytometry (ONE study FACS panel) [ Time Frame: Before start of treatment, 3 and 6 weeks after start of treatment as well as through study completion, an average of 1 year ]
    As part of the course of therapy during routine check-up, blood samples are collected and then analyzed by flow cytometry (ONE study panel). Frequency of surface antigens of PBMC are analyzed and the characterized sub-populations are monitored during the follow-up. Thereby, changes in frequency of surface antigens will be assessed compared to baseline (before start of treatment). This allows to determine the individual immunophenotype of a patient.

  2. Change in activation status of peripheral immune cell populations assessed by immune monitoring through flow cytometry (ONE study FACS panel) [ Time Frame: Before start of treatment, 3 and 6 weeks after start of treatment as well as through study completion, an average of 1 year ]
    As part of the course of therapy during routine check-up, blood samples are collected and then analyzed by flow cytometry (ONE study panel). Expression level of surface antigens of PBMC are analyzed and the characterized sub-populations are monitored during the follow-up. Thereby, changes in expression level of surface antigens will be assessed compared to baseline (before start of treatment). This allows to determine the individual immunophenotype of a patient.


Secondary Outcome Measures :
  1. Liver inflammation (ALT) [ Time Frame: Before start of treatment, 3 and 6 weeks after start of treatment as well as through study completion, an average of 1 year ]
    Screening for liver inflammation (serum ALT U/l)

  2. Liver inflammation (AST) [ Time Frame: Before start of treatment, 3 and 6 weeks after start of treatment as well as through study completion, an average of 1 year ]
    Screening for liver inflammation (serum AST U/l)


Biospecimen Retention:   Samples With DNA
blood samples (10ml EDTA)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic melanoma of all ages and both sexes will be screened for inclusion if they qualify for systemic therapy.
Criteria

Inclusion Criteria:

  • Presence of metastatic melanoma expecting treatment with immune or targeted therapy

Exclusion Criteria:

  • <18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158544


Contacts
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Contact: Sebastian Haferkamp +499419440 Sebastian.Haferkamp@klinik.uni-regensburg.de

Locations
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Germany
Dept. of Dermatology; Univeristy Hospital Regensburg Recruiting
Regensburg, Bavaria, Germany, 93053
Contact: Sebastian Haferkamp, MD    +499419440    Sebastian.Haferkamp@klinik.uni-regensburg.de   
Sponsors and Collaborators
University of Regensburg
Investigators
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Principal Investigator: Edward K Geissler, Phd Dept. of Exp. Surgery, University Hospital Regensburg

Publications:

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Responsible Party: Edward Geissler, Head of Experimental Surgery, University of Regensburg
ClinicalTrials.gov Identifier: NCT04158544     History of Changes
Other Study ID Numbers: 16-101-0125
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edward Geissler, University of Regensburg:
Immune monitoring
Immunotherapy
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas