NCT03514368

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 770 (estimated)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Cancers

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-05-28
• Primary completion: 2029-11-01
• Completion: 2029-11-01
• First posted: 2018-05-02
• Last updated: 2026-02-19

Locations

3 sites across 1 country: France