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

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ClinicalTrials.gov Identifier: NCT02840058
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cancer Other: Biological samples Drug: Anti PD1/PDL1 treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1
Actual Study Start Date : July 2016
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840058


Contacts
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Contact: Laura MANSI, Dr mansi.laura@gmail.com
Contact: Christophe BORG, Pr christophe.borg@efs.sante.fr

Locations
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France
University Hospital of Besançon Recruiting
Besancon, France, 25000
Contact: Laura MANSI, Dr       lmansi@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
More Information
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02840058    
Other Study ID Numbers: API/2015/58
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021