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

March 4, 2026 updated by: Centre Hospitalier Universitaire de Besancon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

295

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • University hospital of Besançon
      • Marseille, France
        • Institut Paoli Calmette
      • Montbéliard, France, 25200
        • Hopital Nord Franche-Comte
      • Paris, France
        • Hopital Saint-Louis - APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2016

Primary Completion (Actual)

July 23, 2024

Study Completion (Actual)

July 15, 2025

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimated)

July 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • API/2015/58

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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