Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy of Immunotherapy in Patients With Early Stage Cancer

Обзор

This is a translational, multicentric, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), and investigate the immunological dynamics associated with neo-adjuvant immunotherapy in patients with multiple types of early stage solid cancers treated with ICB ± chemotherapy or other therapies, prior to surgery (and after surgery if adjuvant ICB treatment is also administered). 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 in a neo-adjuvant setting (whether in standard of care or within a clinical trial). For each included patient, blood samples will be collected at different time points. Tumor samples will be made available for the research however, no biopsy will be performed specifically for this study. All included patients will be followed up for 5 years after baseline.

Вмешательства

• Другое Patients treated with immune checkpoint blockade in neo-adjuvant setting and possibly in adjuvant setting (if applicable)
  Blood samples will be collected at different time points: * Baseline: before the neo-adjuvant ICB treatment * At surgery * During the adjuvant immunotherapy (if applicable): * before the 3rd ICB administration * before the 5th ICB administration * at the time of treatment permanent discontinuation * at the time of recurrence * During the follow-up period : twice a year for maximum of 5 year duration since baseline A fragment of tumor samples will be analyzed as part of the research. The

Первичные конечные точки

• - NSCLC / Head & Neck / Melanoma: Rate of major pathological response - Bladder cancer: rate of complete pathological response - Exploratory: rate of pathological response [Срок оценки: 5 years per patient]

Вторичные конечные точки (2)

• Event-free survival (EFS) [Срок оценки: 5 years per patient]
• Overall survival (OS) [Срок оценки: 5 years per patient]

Критерии участия

• Inclusion Criteria:

• Age ≥18 years at the time of study entry.
• Patient with histologically documented early stage solid malignant tumor (NSCLC, head and neck cancer, melanoma (except uveal melanoma), bladder cancer or any other early stage solid tumor when I-O agent is expected to be efficient in a neo-adjuvant setting (whether in standard of care or within a clinical trial).
• Patient for whom a neo-adjuvant 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 with chemotherapy or other therapies has been decided.
• Availability of an archived tumor specimen (block FFPE) sampled prior to the start of the treatment.
• Treatment with ICB not yet started.
• 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.

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

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

Идентификаторы

NCT: NCT07427186 · 26 GENE 01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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