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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- UCP-specific Th1 responses measured by ELISPOT assay [ Time Frame: up to 12 months ]
- 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.
- 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 ]
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
|Contact: Olivier ADOTEVI, Premail@example.com|
|Contact: Virginie WESTEEL, Prfirstname.lastname@example.org|
|Centre Hospitalier Régional Universitaire de Besançon||Recruiting|
|Principal Investigator: Virginie WESTEEL, Pr|
|CHU de Dijon||Recruiting|
|Dijon, France, 21079|
|Contact: Pascal Foucher, Dr|
|Centre Georges François Leclerc||Recruiting|
|Principal Investigator: Bruno COUDERT, Dr|
|Institut Jean Godinot||Recruiting|
|Principal Investigator: Alain PREVOST, Dr|
|Hôpitaux Universitaires de Strasbourg||Recruiting|
|Principal Investigator: Elisabeth QUOIX, Pr|