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NCT02838433 Clinical Trial

Study of Anti-telomerase T CD4 Immunity in Melanoma

Melanoma Clinical Trial

— LyTéloMel  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02838433
Other study ID # T/2011/03
Secondary ID
Status Recruiting
Phase N/A
First received July 18, 2016
Last updated July 19, 2016
Start date January 2012
Est. completion date July 2018

Study information
Verified date July 2016
Source Centre Hospitalier Universitaire de Besancon
Contact François AUBIN, Pr
Email faubin@chu-besancon.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date July 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Other:
• biological samples
blood and tissue samples

Locations
Country Name City State
France Centre Hospitalier Régional Universitaire de Besançon Besançon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of spontaneous UCP-specific Th1 responses measured by ELISPOT assay 12 months No
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