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Recruiting NCT03514368

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

Trial Parameters

Condition Solid Cancers
Sponsor Institut Claudius Regaud
Study Type INTERVENTIONAL
Phase N/A
Enrollment 770
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2018-05-28
Completion 2029-11
Interventions
Patients treated with immune checkpoint blockade

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥18 years at the time of study entry. 2. Patient with histologically documented metastatic and/or unresectable solid malignant tumor (NSCLC, head and neck, melanoma (except uveal melanoma), bladder cancer or any other advanced solid tumor when I-O agent is expected to be efficient or when a clinical trial is an option). 3. Patient for which a treatment with immune checkpoint blockade including, but not limited to, anti-PD-1, anti-PD-L1 and anti-CTLA-4 mAb alone or in combination has been decided. 4. Archived tumor specimen available or feasible for pre-treatment tumor biopsy. 5. Current treatment with ICB not yet started. 6. Evaluable disease (measurable as per RECIST 1.1. or not). 7. ECOG Performance status 0-2. 8. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures. 9. Patient affiliated to a Social Health Insurance in France. Exclusion Criteria: 1. Patient pregnant, or breast-feeding. 2. Uve

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