A Feasibility Study to Identify T-cell Responses to Neo-epitopes in Tumor Invaded Lymph Nodes (NeoEpitope)

Overview

Feasibility study for a method allowing identification of tumor mutated epitopes in patients with breast cancer or cutaneous melanoma, and quantification of CD8+ T cells specific for these tumor neo-antigens in their lymph nodes

Full Title of Study: “A Feasibility Study to Identify T-cell Responses to Neo-epitopes in Tumor Invaded Lymph Nodes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2018

Interventions

  • Procedure: Blood sampling
    • After inclusion in the protocol, a blood sample (50 mL in EDTA tubes) will be withdrawn during pre-operative consultation.

Arms, Groups and Cohorts

  • Other: Blood sampling

Clinical Trial Outcome Measures

Primary Measures

  • Feasibility of a method allowing identification of tumor mutated epitopes in patients with breast cancer or cutaneous melanoma and quantification of CD8+ T cells specific for the tumor neo-antigens identified in the lymph nodes.
    • Time Frame: up to 24 months
    • Feasibility study for a method allowing identification of tumor mutated epitopes : Identification of MHC cl I and II restricted tumor neo-epitopes by two different methods i.e. by an elution-HPLC method performed on cell lines derived from tumor cells obtained from invaded lymph node, or using predictive algorithms on tumor sequencing data.

Secondary Measures

  • Quantification of CD4+ T lymphocytes specific for identified tumor neo-antigens in the lymph nodes.
    • Time Frame: up to 24 months
  • Quantification of CD4+ and CD8+ T lymphocytes specific for identified neo-antigens in the blood and tumor.
    • Time Frame: up to 24 months
  • Comparison of the frequency and relative amplitude of the T cell response specific for the tumor neo-epitopes with other immune responses and responses against known tumor antigens.
    • Time Frame: up to 24 months
    • Comparison of the frequency and relative amplitude of the T cell response specific for the tumor neo-epitopes with other immune responses such as anti-viral memory responses (influenza A, …), chronic viral responses (cytomegalovirus [CMV] Epstein-Barr virus [EBV], …) and responses against known tumor antigens (such as NY-ESO-1, MAGE-A3, p53, gp100 ….).

Participating in This Clinical Trial

Inclusion Criteria

Patients over 18 years Patient with HR+ , HER2- and node-positive (proven by cytology) invasive ductal carcinoma breast cancer, grade (SBR) II or III, and having an axillary dissection programmed, Or patient having cutaneous melanoma scheduled for a lymph node dissection at the Institut Curie including dissection of the lymph nodes draining the tumor, Voluntary having signed and dated written informed consents prior to any specific study procedure, Exclusion Criteria:

Patients treated for a breast cancer who received neoadjuvant chemotherapy Patients treated for breast cancer with distant metastases (M+)• Only for patients with breast cancer: oral or systemic corticosteroids treatment received within 30 days prior surgery Patients on immunosuppressive treatment or diagnosed of an immunodeficiency Patients with known chronic viral infection as HIV1 or 2, HBV, HCV Patients with other cancer diagnosed within 5 years (except squamous cell cutaneous carcinomas) Patients without a French social security Patients deprived of liberty or placed under the authority of a tutor

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut Curie
  • Collaborator
    • Genentech, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.