Locoregional or Systemic Administration of Autologous Tumor Infiltrating Lymphocytes in Patients With Metastatic Melanoma

Обзор

The purpose of this study is to evaluate the feasibility, safety and tolerability of locoregional or systemic administration of autologous tumor infiltrating lymphocytes in patients with metastatic melanoma

Вмешательства

• Препарат Autologous Tumor Infiltrating Lymphocytes (TIL)
  Cohort 1: Administered via hepatic arterial infusion Cohort 2: Administered via intravenous infusion
• Препарат Melphalan
  1 mg/kg, IV
• Препарат Interleukin-2
  2 MIU, subcutaneous twice daily for up to 14 days.

Первичные конечные точки

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

Вторичные конечные точки (6)

• Objective response rate (ORR) [Срок оценки: 2 years]
• Progression free-survival (PFS) [Срок оценки: 2 years]
• hepatic Progression-free survival (hPFS) [Срок оценки: 2 years]
• Duration of objective response (DOR) [Срок оценки: 2 years]
• Overall Survival (OS) [Срок оценки: 5 years]
• Evaluation of feasibility of an automated production of TILs [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Participants must be at least 18 years of age.
• Can provide a signed informed consent as described in the protocol, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
• World Health Organization (WHO) Performance Status 0 or 1.
• Patient must have a histologically/cytologically confirmed diagnosis of:

• stage IV uveal melanoma with confirmed progression following prior systemic therapy with tebentafusp (if HLA A2:01 positive) OR
• stage IV cutaneous melanoma with confirmed progression following prior systemic therapy with a programmed cell death protein-1 (PD-1) inhibitor with or without a CTLA-4 inhibitor
• At least one resectable lesion in the liver (or aggregate of lesions resected) of a minimum size of 0.5 cm in diameter to generate TILs.
• Measurable disease by computed tomography (CT) per RECIST 1.1 criteria after resection of lesion for TILs production
• No other malignancies, except if treated with curative intent and with a cancer-related life expectancy of more than 5 years.
• Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Female patients of childbearing potential must be willing to use a highly efficient method of contraception (Pearl index <1), for the course of the study through 120 days after the last dose of study medication.
• Male patients with women of childbearing potential partners must agree to use a condom for contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.

Критерии исключения

• Any serious or uncontrolled medical conditions that, in the investigator's opinion, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy (including operation), or interfere with the interpretation of study results.
• Subjects with 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.
• Women who are pregnant or breastfeeding.
• Any condition that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07183852 · GoTIL_2025EU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗