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

NCT02840058 | Completed

• 1 other identifier: API/2015/58
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 4

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Biological samples

EXPERIMENTAL

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; Drug: Anti PD1/PDL1 treatment

Interventions

Biological samples OTHER

blood and tumor tissue samples

Biological samples

Anti PD1/PDL1 treatment DRUG

Biological samples

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (4)

University Hospital of Besançon

Besançon, 25000, France

Location

Institut Paoli Calmette

Marseille, France

Location

Hôpital Nord Franche-Comté

Montbéliard, 25200, France

Location

Hôpital Saint-Louis - APHP

Paris, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 21, 2016
• Study Start: August 31, 2016
• Primary Completion: July 23, 2024
• Study Completion: July 15, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

FR (4)