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
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.
stage IV uveal melanoma with confirmed progression following prior systemic therapy with tebentafusp (if HLA A2:01 positive) OR
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.
Parallel
Autologous Tumor Infiltrating Lymphocytes (TIL)
DrugCohort 1: Administered via hepatic arterial infusion Cohort 2: Administered via intravenous infusion
Melphalan
Drug1 mg/kg, IV
Interleukin-2
Drug2 MIU, subcutaneous twice daily for up to 14 days.
Incidence and severity of adverse events
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Objective response rate (ORR)
RECIST 1.1
Progression free-survival (PFS)
Evaluation of Progression-free survival
hepatic Progression-free survival (hPFS)
Evaluation of hepatic Progression-free survival
Duration of objective response (DOR)
Evaluation of duration of a response by RECIST 1.1
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This trial is not recruiting at the moment. You can still explore other options:
