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Not yet recruiting NCT05903937

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

Phase I Interventional Uveal Melanoma Metastatic Cutaneous Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous Tumor Infiltrating Lymphocytes, Melphalan, Interleukin-2.
Who it may be relevant to
Registry conditions: Uveal Melanoma, Metastatic Cutaneous Melanoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Incidence and severity of adverse events [Time frame: 5 years]
Secondary outcome measures (6)
  • Objective response rate [Time frame: 5 years]
  • Progression-free survival [Time frame: 5 years]
  • hepatic Progression-free survival [Time frame: 5 years]
  • Duration of response [Time frame: 5 years]
  • Overall survival [Time frame: 5 years]
  • Evaluation of Tolerability [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05903937 · 2023-006126-32

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗