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

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

NCT ID: NCT05903937

Condition: Uveal Melanoma
Metastatic Cutaneous Melanoma

Conditions: Official terms:
Melanoma
Melphalan
Interleukin-2

Conditions: Keywords:
TIL
ACT
PHP

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Autologous Tumor Infiltrating Lymphocytes
Description: Administered via hepatic arterial infusion (HAI)
Arm group label: Autologous tumor infiltrating lymphocytes (TIL)

Intervention type: Drug
Intervention name: Melphalan
Description: Administered via isolated hepatic perfusion
Arm group label: Autologous tumor infiltrating lymphocytes (TIL)

Intervention type: Drug
Intervention name: Interleukin-2
Description: low-dose, administered s.c.
Arm group label: Autologous tumor infiltrating lymphocytes (TIL)

Summary: 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

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: December 31, 2023

Completion date: December 31, 2029

Lead sponsor:
Agency: Vastra Gotaland Region
Agency class: Other

Source: Vastra Gotaland Region

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05903937