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

Cancer Clinical Trial

— ITHER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02840058
• Other study ID #: API/2015/58
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 2022

Study information

• Verified date: July 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Laura MANSI, Dr
• Email: mansi.laura[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Biological samples
blood and tumor tissue samples

Drug:
• Anti PD1/PDL1 treatment

Locations

Country	Name	City	State
France	University Hospital of Besançon	Besancon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

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