Study of Anti-telomerase T CD4 Immunity in Melanoma

Not Applicable

• Conditions: Melanoma
• Interventions: Other: biological samples

• Registration Number: NCT02838433
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2016-07
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-19
• Last Update Submitted: 2016-07-19
• Study First Posted: 2016-07-20
• Last Update Posted: 2016-07-20
• Primary Completion: 2018-01
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biological samples	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.

Primary Outcome Measures

Name	Time	Method
Presence of spontaneous UCP-specific Th1 responses measured by ELISPOT assay	12 months

Trial Locations

Locations (1)

Centre Hospitalier Régional Universitaire de Besançon; 🇫🇷 Besançon, France