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Study of Anti-telomerase T CD4 Immunity in Metastatic Lung Cancer (Telocap02)

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ClinicalTrials.gov Identifier: NCT02846103
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:

Increasing evidence suggests that immune responses might be a determining factor in lung cancer tumor progression.

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 is required for their efficacy and highlight the critical role of antitumor T cell immunity. Recent progress on the fields of tumor immunology underlines 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 group 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, pre-existing UCP-specific Th1 responses have been detected in the blood of lung cancer patients (Telocap01). The frequency and magnitude of this response were inversely correlate to the disease stage. Furthermore, UCP-specific responses were significantly found in patients with low PD1+ and TIM3+ T cells.

Then in TeloCap02 study, UCP specific Th1 immune responses will be evaluated in lung cancer before and after treatment (chemotherapy, immunotherapy).


Condition or disease Intervention/treatment Phase
Lung Cancer Other: Biological samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of Anti-telomerase T CD4 Immunity in Metastatic Lung Cancer
Actual Study Start Date : December 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biological samples

Blood samples will be collected at baseline, after the first-line therapy and at 12 months.

Tumor tissues will be collected if available.

Other: Biological samples
blood and tumor tissue samples




Primary Outcome Measures :
  1. overall survival [ Time Frame: date of death from any cause (within 2 years after the initiation of the treatment) ]
    time between the date of initiation of treatment and the date of death from any cause


Secondary Outcome Measures :
  1. UCP-specific Th1 responses measured by ELISPOT assay [ Time Frame: up to 12 months ]
  2. Progression free survival [ Time Frame: date of first progression of the disease (within 2 years after the initiation of the treatment) ]
    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.

  3. quality of life related to health measured by EORTC-QLQC30 and LC13 questionaries. [ Time Frame: from the inclusion to patient death, up to 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed NSCLC (Non Small Cell Lung Cancer) or SCLC (small cell lung cancer)
  • stade IIIb or metastatic
  • Patient candidate to a first-line therapy
  • Performance status 0, 1 or 2 on the ECOG scale
  • Written informed consent

Exclusion Criteria:

  • History of adjuvant chemotherapy for lung cancer treatment
  • Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
  • Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
  • Active autoimmune diseases, HIV, hepatitis C or B virus
  • Patients with any medical or psychiatric condition or disease,
  • Patients under guardianship, curatorship or under the protection of justice.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846103


Contacts
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Contact: Olivier ADOTEVI, Pr olivier.adotevi@univ-fcomte.fr
Contact: Virginie WESTEEL, Pr virginie.westeel@univ-fcomte.fr

Locations
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France
Centre Hospitalier Régional Universitaire de Besançon Recruiting
Besançon, France
Principal Investigator: Virginie WESTEEL, Pr         
CHU de Dijon Recruiting
Dijon, France, 21079
Contact: Pascal Foucher, Dr         
Centre Georges François Leclerc Recruiting
Dijon, France
Principal Investigator: Bruno COUDERT, Dr         
Institut Jean Godinot Recruiting
Reims, France
Principal Investigator: Alain PREVOST, Dr         
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France
Principal Investigator: Elisabeth QUOIX, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Publications:
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02846103    
Other Study ID Numbers: P/2013/207
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases