Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma … (NCT04812470) | Clinical Trial Compass
CompletedPhase 1
Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases
Sweden8 participantsStarted 2023-02-06
Plain-language summary
The purpose of this study is to evaluate the feasibility, safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion in patients with liver metastases (including but not restricted to) of malignant melanoma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients 18-75 years of age on the day of signing informed consent.
✓. 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:
✓. 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 - 2.
✓. 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.
Exclusion criteria
✕. Life expectancy of less than 3 months.
✕. History of interstitial lung disease (ILD) or (non-infectious) pneumonitis.
What they're measuring
1
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
✕. 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.
✕. History of severe hypersensitivity reactions to monoclonal antibodies.