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

NCT ID: NCT02840058

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Biological samples

Intervention Type OTHER

blood and tumor tissue samples

Anti PD1/PDL1 treatment

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biological samples

blood and tumor tissue samples

Intervention Type OTHER

Anti PD1/PDL1 treatment

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of Besançon

Besançon, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Laura MANSI, Dr

Role: CONTACT

Christophe BORG, Pr

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Laura MANSI, Dr

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

API/2015/58

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Immune Cell Therapy for Advanced Solid Tumors
NCT07260058 NOT_YET_RECRUITING PHASE1/PHASE2