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RECRUITING
NCT03514368
NA

Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy

Sponsor: Institut Claudius Regaud

View on ClinicalTrials.gov

Summary

This is a translational, open-label, multi-site, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), in patients with multiple types of advanced (unresectable and/or metastatic) solid cancers. The study will be conducted on a population of patients receiving ICB (anti-PD-1 or anti-PD-L1 or anti-CTLA4, alone or in combination) in the context of either routine care or a clinical study protocol. Patients with any of the following tumor types may be enrolled in the trial: * Non-Small Cell Lung Cancer (NSCLC), * Head and neck cancer, * Melanoma, * Bladder cancer, * Other tumor types when Immuno-Oncology agent is expected to be efficient or when a clinical trial is an option. For each included patient, tumor biopsy specimens and blood samples will be collected at different time points. All included patients will be followed-up until progression. After this date, survival data will be collected.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

770

Start Date

2018-05-28

Completion Date

2029-11

Last Updated

2026-02-19

Healthy Volunteers

No

Conditions

Interventions

OTHER

Patients treated with immune checkpoint blockade

Tumor biopsy specimens and blood samples will be collected at different time points: * Baseline * before the 3rd ICB administration (blood samples only) * before the 5th ICB administration (blood samples only) * at the time of treatment permanent discontinuation (blood samples only) * at the time of progression (tumor biopsy specimens only) * after the last dose of ICB treatment (blood samples only taken twice per year until study termination)

Locations (3)

Hopital Larrey

Toulouse, France

Institut Universitaire Du Cancer de Toulouse - Oncopole

Toulouse, France

Chu Rangueil

Toulouse, France