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ClinicalTrials.gov ID

NCT03514368

Lead Sponsor

Institut Claudius RegaudOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

770Estimated

Last Update Posted

Jun 16, 2026Actual

Start Date

May 28, 2018Actual

Primary Completion Date

Nov 2029Estimated

Completion Date

Nov 2029Estimated

Official Title

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

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.

• Solid Cancers

• Patients treated with immune checkpoint blockade

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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. Uveal melanoma
3. Any condition contraindicated with tumor /blood sampling procedures required by the protocol.
4. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders.
6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
7. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

Primary Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Institut Claudius RegaudOTHER

fares.n@chu-toulouse.fr05 61 32 21 42