Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1

Study Overview
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Brief Summary
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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.

Official Title
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Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1

Conditions
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Cancer

Intervention / Treatment
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* Other: Biological samples
* Drug: Anti PD1/PDL1 treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biological samples<br>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<br>* blood and tumor tissue samples<br>Drug: Anti PD1/PDL1 treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-telomerase specific Th1 responses | measured by ELISPOT assay | up to 12 months after the initiation of anti-PD1/PDL1 therapy | 
| objective response rate | according to RECIST v1.1 criteria | up to 12 months after the initiation of anti-PD1/PDL1 therapy |