Cancer
Conditions
Brief summary
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.
Interventions
OTHERBiological samples
blood and tumor tissue samples
DRUGAnti PD1/PDL1 treatment
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anti-telomerase specific Th1 responses | up to 12 months after the initiation of anti-PD1/PDL1 therapy | measured by ELISPOT assay |
| objective response rate | up to 12 months after the initiation of anti-PD1/PDL1 therapy | according to RECIST v1.1 criteria |
Countries
France
Outcome results
None listed