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

  • STATUS
    Recruiting
  • End date
    Nov 26, 2024
  • participants needed
    440
  • sponsor
    Institut Claudius Regaud
Updated on 26 January 2021

Summary

This trial is a translational, open-label, multi-site, prospective cohort study of 440 patients 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.

Details
Condition Solid Cancers
Treatment Patients treated with immune checkpoint blockade
Clinical Study IdentifierNCT03514368
SponsorInstitut Claudius Regaud
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years at the time of study entry
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)
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
Archived tumor specimen available or feasible for pre-treatment tumor biopsy
Current treatment with ICB not yet started
Evaluable disease (measurable as per RECIST 1.1. or not)
ECOG Performance status 0-2
Patient able to participate and willing to give informed consent prior to performance of any study-related procedures
Patient affiliated to a Social Health Insurance in France

Exclusion Criteria

Patient pregnant, or breast-feeding
Uveal melanoma
Any condition contraindicated with tumor /blood sampling procedures required by the protocol
Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders
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
Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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