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

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Melanoma

Treatments: Other: biological samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02838433

T/2011/03

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

200 participants in 1 patient group

Biological samples

Experimental group

Description:

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.

Treatment:

Other: biological samples