NCT02817178

Brief Summary

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 OncoImmunology 2012 and unpublished data).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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2017

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2020

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

4.3 years

First QC Date

June 27, 2016

Last Update Submit

May 10, 2022

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    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.

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

Study Arms (1)

Additional biological samples

OTHER

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.

Other: Additional biological samples

Interventions

Additional biological samplesOTHER

blood and tumor tissue samples

Additional biological samples

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Centre Hospitalier Régional Universitaire de Besançon

Besançon, France

Location

Polyclinique de Franche-Comté

Besançon, France

Location

Hôpitaux Civils de Colmar

Colmar, France

Location

Centre Georges François Leclerc

Dijon, France

Location

Hôpital Nord Franche-Comté

Montbéliard, France

Location

Institut de Cancérologie de Lorraine

Nancy, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Centre Paul Strauss

Strasbourg, France

Location

Centre Hospitalier Universitaire de Tours

Tours, France

Location

Related Publications (1)

  • Kroemer M, Turco C, Spehner L, Viot J, Idirene I, Bouard A, Renaude E, Deschamps M, Godet Y, Adotevi O, Limat S, Heyd B, Jary M, Loyon R, Borg C. Investigation of the prognostic value of CD4 T cell subsets expanded from tumor-infiltrating lymphocytes of colorectal cancer liver metastases. J Immunother Cancer. 2020 Nov;8(2):e001478. doi: 10.1136/jitc-2020-001478.

    PMID: 33229508DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Stefano KIM, Dr

    CHU DE BESANCON

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 27, 2016

First Posted

June 29, 2016

Study Start

March 1, 2013

Primary Completion

June 11, 2017

Study Completion

July 6, 2020

Last Updated

May 11, 2022

Record last verified: 2022-05

Locations

FR(9)