Study of Anti-telomerase T CD4 Immunity in Melanoma (LyTéloMel)

July 19, 2016 updated by: Centre Hospitalier Universitaire de Besancon

Study of Anti-telomerase T CD4 Immunity in Melanoma: Predictive Biomarker and Implications for Immunotherapy

The impressive clinical responses obtained with immune checkpoint inhibitors (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune response might be required for their efficacy and highlight the critical role of antitumor T cell immunity.

Recent progresses on the field of tumor immunology underline the critical role of CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.

In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the investigators team have previously described novel promiscuous peptides (referred as UCP: Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor antigen.

By using UCP-based immuno-assay, UCP specific Th1 immune responses will be evaluated in this study in melanoma before and after treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

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

  • France
      • Besançon, France
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Besançon
        • Contact:
          • François Aubin, Pr
        • Principal Investigator:
          • François AUBIN, Pr

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient with melanoma, any stade, without history of anti-cancer treatment (surgery, chemotherapy, targeted therapy, immunotherapy...) except for patients with stade IV melanoma for which immunotherapy or targeted therapy is considered. In this case, a first-line chemotherapy treatment is allowed
  • written informed consent

Exclusion Criteria:

  • patient with immunosuppressive treatment
  • active autoimmune diseases, HIV, hepatitis C or B virus
  • patients under guardianship, curatorship or under the protection of justice, pregnant women

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biological samples

Blood samples will be collected :

  • at baseline,
  • 6 months after the first-line therapy or at disease progression (if occurs first).

In particular case of patient with immunotherapy or targeted therapy, 3 blood samples will be collected :

  • at baseline
  • 3 months after the initiation of immunotherapy or targeted therapy
  • at disease progression Tumor tissues will be collected if available.
Other: biological samples
blood and tissue samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of spontaneous UCP-specific Th1 responses measured by ELISPOT assay
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

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

January 1, 2012

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T/2011/03

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.

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