Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1 (ITHER)
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|ClinicalTrials.gov Identifier: NCT02840058|
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : August 2, 2021
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Recent scientific advances have shown the important role of immune system against cancer. Today, many immunological biotherapy like anti-PD1/PDL-1 are available in cancer treatment and generate durable clinical responses in some patients. The development of tools for monitoring anti-tumor immune responses dynamically is a major challenge to predict the effectiveness of immunotherapies anti-PD-1 and anti-PDL-1.
Thus, the objective of our study is to analyse the interest of the monitoring of anti-telomerase T helper 1 (TH1) responses in predicting the efficacy of immunotherapy, using an immunoassay developed by our group.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Other: Biological samples Drug: Anti PD1/PDL1 treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Biological samples
Blood samples will be realized specifically to the study at inclusion (baseline before starting anti PD1/PDL1 treatment), and then 1 month, 3 months and 12 months after initiation of anti-PD1/PDL1 treatment.
Peripheral blood mononuclear cells (PBMC) and plasma will be collected.
Available tumor tissues will be collected.
Other: Biological samples
blood and tumor tissue samples
Drug: Anti PD1/PDL1 treatment
- anti-telomerase specific Th1 responses [ Time Frame: up to 12 months after the initiation of anti-PD1/PDL1 therapy ]measured by ELISPOT assay
- objective response rate [ Time Frame: up to 12 months after the initiation of anti-PD1/PDL1 therapy ]according to RECIST v1.1 criteria
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|Ages Eligible for Study:||18 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patient with metastatic or locally advanced cancer candidate to anti-PD1/PDL1 immunotherapy
- Performance status 0, 1 or 2 on the ECOG scale
- Written informed consent
- 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.
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): NCT02840058
|Contact: Laura MANSI, Drfirstname.lastname@example.org|
|Contact: Christophe BORG, Premail@example.com|
|University Hospital of Besançon||Recruiting|
|Besancon, France, 25000|
|Contact: Laura MANSI, Dr firstname.lastname@example.org|
|Responsible Party:||Centre Hospitalier Universitaire de Besancon|
|Other Study ID Numbers:||
|First Posted:||July 21, 2016 Key Record Dates|
|Last Update Posted:||August 2, 2021|
|Last Verified:||July 2021|