Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer … (NCT03514368) | Clinical Trial Compass
RecruitingNot Applicable
Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy
France770 participantsStarted 2018-05-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
Exclusion criteria
✕
What they're measuring
1
Rate of objective response (complete or partial response)
✕. 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.