Study of Anti-telomerase T CD4 Immunity in Melanoma

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02838433

Acronym

LyTéloMel

Enrollment

200

Registered

2016-07-20

Start date

2012-01-31

Completion date

2018-07-31

Last updated

2016-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Brief 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.

Interventions

OTHERbiological samples

blood and tissue samples

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Contacts

Primary ContactFrançois AUBIN, Pr

faubin@chu-besancon.fr

Backup ContactOlivier ADOTEVI, Pr

olivier.adotevi@univ-fcomte.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026