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

Обзор

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.

Вмешательства

• Другое Patients treated with immune checkpoint blockade
  Tumor biopsy specimens and blood samples will be collected at different time points: * Baseline * before the 3rd ICB administration (blood samples only) * before the 5th ICB administration (blood samples only) * at the time of treatment permanent discontinuation (blood samples only) * at the time of progression (tumor biopsy specimens only) * after the last dose of ICB treatment (blood samples only taken twice per year until study termination)

Первичные конечные точки

• Rate of objective response (complete or partial response) [Срок оценки: 18 months by patient]

Вторичные конечные точки (3)

• Progression Free Survival defined as the time from inclusion until progression according to investigator judgment, or death, whichever occurs first. [Срок оценки: 18 months by patient]
• Anti-tumor immune responses under immunotherapy defined by investigator judgment and/or iRECIST criteria [Срок оценки: 18 months by patient]
• Immune related adverse event (irAE) will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 [Срок оценки: 12 months by patient]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 3 центра

• Hopital Larrey — Toulouse
• Institut Universitaire Du Cancer de Toulouse - Oncopole — Toulouse
• Chu Rangueil — Toulouse

Идентификаторы

NCT: NCT03514368 · 17 GENE 23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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