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

Launched by INSTITUT CLAUDIUS REGAUD · May 1, 2018

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system responds to specific cancer treatments called immune checkpoint inhibitors (ICB). These treatments can help the body’s immune system recognize and fight cancer cells. The researchers want to learn more about certain markers in the blood and tumors that might indicate how well these treatments work or if they cause side effects. The trial will include 520 patients with various advanced solid cancers, such as lung cancer, head and neck cancer, melanoma, and bladder cancer, who are about to start treatment with ICB.

To be eligible for this trial, participants need to be at least 18 years old and have a specific type of advanced cancer that has not been successfully treated with surgery. They must be starting ICB treatment soon and have a sample of their tumor available for testing. During the trial, blood and tumor samples will be collected at different times to monitor changes. Participants will be followed until their cancer progresses, and information about their health and survival will be gathered afterward. This study aims to better understand how to improve cancer treatment and manage any potential side effects.

Gender

ALL

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.