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

Not Applicable

• Conditions: Cancer
• Interventions: Other: Biological samples; Drug: Anti PD1/PDL1 treatment

• Registration Number: NCT02840058
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-02
• Primary Completion: 2022-03
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biological samples	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.
Biological samples	Anti PD1/PDL1 treatment	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Besançon; 🇫🇷 Besancon, France