Locoregional Administration of TIL and Lymphodepletion in Patients With Melanoma and Liver Metastases

Официальное название

Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes Preconditioned With Percutaneous Hepatic Perfusion With Melphalan in Patients With Melanoma and Liver Metastases

Обзор

Evaluate the safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion and preconditioning with percutaneous hepatic perfusion in patients with liver metastases (but not restricted to) of malignant melanoma

Вмешательства

• Препарат Autologous Tumor Infiltrating Lymphocytes
  Administered via hepatic arterial infusion (HAI)
• Препарат Melphalan
  Administered via isolated hepatic perfusion
• Препарат Interleukin-2
  low-dose, administered s.c.

Первичные конечные точки

• Incidence and severity of adverse events [Срок оценки: 5 years]

Вторичные конечные точки (6)

• Objective response rate [Срок оценки: 5 years]
• Progression-free survival [Срок оценки: 5 years]
• hepatic Progression-free survival [Срок оценки: 5 years]
• Duration of response [Срок оценки: 5 years]
• Overall survival [Срок оценки: 5 years]
• Evaluation of Tolerability [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Patient is willing and able to provide written informed consent and comply with study procedures. Written informed consent must be signed and dated before the start of specific protocol procedures.
• Patient must have a histologically/cytologically confirmed diagnosis of:
• stage IV uveal melanoma with or without any previous systemic therapy OR
• stage IV cutaneous melanoma with confirmed progression following at least one or two prior systemic therapies including a programmed cell death protein-1 (PD-1) inhibitor with or without a CTLA-4 inhibitor; and if BRAF V600 mutation-positive, also a BRAF inhibitor or a BRAF inhibitor in combination with a MEK inhibitor.
• Measurable disease by computed tomography (CT) per RECIST 1.1 criteria with at least one target lesion identified in the liver and where the distribution pattern of metastasis is predominantly engaging the liver as judged by the investigator.
• At least one resectable lesion in the liver (or aggregate of lesions resected) of a minimum size of 0.5 cm in diameter post- resection to generate TILs.
• ECOG performance status of 0 - 1.

Критерии исключения

• Life expectancy of less than 3 months.
• Reduced renal function defined as S-Creatinine >=1.5xULN or Creatinine Clearance < 40 mL/min, calculated using the Cockroft and Gault formula.
• Reduced hepatic function (defined as ASAT, ALAT, bilirubin > 3\*ULN and PK- INR > 1.5) or medical history of liver cirrhosis or portal hypertension.
• Hemoglobin <90 g/L or platelets <100x109/L or neutrophils <1.5x109/L
• Use of live vaccines four weeks before or after the start of study.
• Infection of human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.
• Active autoimmune disease.
• A condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• Concomitant therapy with any other anti- cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs.
• Has a known additional malignancy of other diagnosis that is progressing or requires active treatment.
• A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator

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

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05903937 · 2023-006126-32

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗