Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy of Immunotherapy in Patients With Early Stage Cancer

This is a translational, multicentric, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), and investigate the immunological dynamics associated with neo-adjuvant immunotherapy in patients with multiple types of early stage solid cancers treated with ICB ± chemotherapy or other therapies, prior to surgery (and after surgery if adjuvant ICB treatment is also administered). 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 in a neo-adjuvant setting (whether in standard of care or within a clinical trial). For each included patient, blood samples will be collected at different time points. Tumor samples will be made available for the research however, no biopsy will be performed specifically for this study. All included patients will be followed up for 5 years after baseline.

NCT Number	NCT07427186
Lead Sponsor	Institut Claudius Regaud
Conditions	Solid Cancers
Enrollment	600 participants
Start Date	2026-04-15
Primary Completion	2041-04-15 (estimated)
Study Completion	2041-04-15 (estimated)
Updated on ClinicalTrials.gov	2026-02-25