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Completed

NCT Number: NCT02840058

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biological Samples

Other

blood and tumor tissue samples

Anti PD1/PDL1 treatment

Drug

Primary outcomes

  1. anti-telomerase specific Th1 responses

    Time frame: up to 12 months after the initiation of anti-PD1/PDL1 therapy

    measured by ELISPOT assay

  2. objective response rate

    Time frame: up to 12 months after the initiation of anti-PD1/PDL1 therapy

    according to RECIST v1.1 criteria

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: ITHER

Important dates

Study start
2016
Primary completion
2024
Study completion
2025
First posted
Jul 21, 2016
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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