NCT07427186

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Solid Cancers

Interventions

Type	Name	Description
OTHER	Patients treated with immune checkpoint blockade in neo-adjuvant setting and possibly in adjuvant setting (if applicable)	Blood samples will be collected at different time points: * Baseline: before the neo-adjuvant ICB treatment * At surgery * During the adjuvant immunotherapy (if applicable): * before the 3rd ICB administration * before the 5th ICB administration * at the time of treatment permanent discontinuation * at the time of recurrence * During the follow-up period : twice a year for maximum of 5 year duration since baseline A fragment of tumor samples will be analyzed as part of the research. They will be collected per SOC at the following timepoints: * Pre-neoadjuvant treatment (archived sample) * At surgery * At progression if a tumor biopsy is clinically indicated

Timeline

• Start date: 2026-04-15
• Primary completion: 2041-04-15
• Completion: 2041-04-15
• First posted: 2026-02-23
• Last updated: 2026-02-25

Locations

3 sites across 1 country: France