Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer (Epitopes-CRC02)

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Metastatic Colorectal Cancer

Treatments: Other: Additional biological samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02817178

Epitopes-CRC02

Details and patient eligibility

About

The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses.

The investigators found high frequency of naturally occuring UCP-specific TH1 cells in long term survival of metastatic colorectal cancer (CRC) previously treated by 5 fluoro-uracil -oxaliplatin (Folfox) +/- bevacizumab regiment (Godet et al. OncoImmunology 2012 and unpublished data).

Epitopes-CRC02 is a French prospective multicenter study which will evaluate the post chemotherapy and post surgery modulation of host tumor-specific CD4 TH1 cell responses in metastatic colorectal cancer patients and their correlation with progression-free survival.

Enrollment: 258 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Performance status ECOG-WHO 0, 1 or 2
• Metastatic colorectal cancer Histologically proved
• signed written informed consent

Exclusion criteria

• previous treatment (chemotherapy, targeted therapy, surgery) for metastatic disease
• history of autoimmune disease
• patients under immunotherapy systemic treatment or immunosuppressive drugs or stopped for less than 6 months to the enrollment in this study.
• corticoids ≥ 1mg/kg
• acute or chronic infectious disease during treatment or stopped for less than six months
• other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
• pregnancy, breast-feeding or absence of adequate contraception for fertile patients
• patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
• patient under guardianship, curator or under the protection of justice.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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258 participants in 1 patient group

Additional biological samples

Other group

Description:

Additional blood samples will be realized specifically to the study at baseline, at 1 month, at 3 months, and 1 month after surgery (if applicable). Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected. Tissue tumor is collected during surgery if applicable.

Treatment:

Other: Additional biological samples