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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Recruiting
CT.gov ID
NCT02840058
Collaborator
(none)
120
Enrollment
1
Location
1
Arm
77
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Biological samples
  • Drug: Anti PD1/PDL1 treatment
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jul 1, 2016
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. anti-telomerase specific Th1 responses [up to 12 months after the initiation of anti-PD1/PDL1 therapy]

    measured by ELISPOT assay

  2. objective response rate [up to 12 months after the initiation of anti-PD1/PDL1 therapy]

    according to RECIST v1.1 criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University Hospital of Besançon Besancon France 25000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT02840058
Other Study ID Numbers:
  • API/2015/58
First Posted:
Jul 21, 2016
Last Update Posted:
Aug 2, 2021
Last Verified:
Jul 1, 2021

Study Results

No Results Posted as of Aug 2, 2021