Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer

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 OncoImmunology 2012 and unpublished data).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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Régional Universitaire de Besançon, Besançon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Additional biological samples

Other

blood and tumor tissue samples

Primary outcomes

Progression-free survival

Time frame: date of first progression of the disease (within 3 years after the enrollment in the study)]

time interval between the date of initiation of treatment and the date of first progression (local, remote [extent of the disease by RECIST v1.1] second cancer) or death from any cause.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Prospective Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer

Acronym: Epitopes-CRC02

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2020
First posted: Jun 29, 2016
Registry last updated: May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed