Study of Anti-telomerase T CD4 Immunity in Melanoma

NCT02838433 | Unknown

• 1 other identifier: T/2011/03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Presence of spontaneous UCP-specific Th1 responses measured by ELISPOT assay

  12 months

Study Arms (1)

Biological samples

EXPERIMENTAL

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

Interventions

biological samples OTHER

blood and tissue samples

Biological samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire de Besançon

Besançon, France

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

François AUBIN, Pr

CONTACT

faubin@chu-besancon.fr

Olivier ADOTEVI, Pr

CONTACT

olivier.adotevi@univ-fcomte.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 20, 2016
• Study Start: January 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

FR (1)