Phase 2 Study of Adoptive Cell Therapy Using Tumor-Infiltrating Lymphocytes and IL-2 With or Without Pembrolizumab for Adults With Metastatic Melanoma

What this Trial Is About

Researchers are evaluating a treatment for metastatic melanoma that combines adoptive cell therapy using tumor infiltrating lymphocytes TIL with high-dose interleukin-2 IL-2, either alone or with the drug pembrolizumab. The study focuses on whether adding pembrolizumab can improve tumor shrinkage and safety in patients who have previously received anti-PD-1PD-L1 therapy. This phase 2 trial includes patients aged 18 to 72 with measurable metastatic melanoma that can be surgically removed to grow TIL cells. Participants undergo a preparative regimen with chemotherapy drugs cyclophosphamide and fludarabine before receiving TIL cells intravenously. Some participants receive pembrolizumab infusions before and after the cell therapy. High-dose IL-2 is given every 8 hours for up to 12 doses following cell infusion. The treatment involves daily chemotherapy for one week, TIL infusion 2-4 days later, and supportive injections to help blood counts recover. Depending on group assignment, pembrolizumab is given on a schedule around the cell infusion. The study includes multiple treatment arms based on prior therapy and pembrolizumab eligibility. During the study, participants have tumor biopsies, blood tests, imaging scans, and heart and lung function tests. They remain hospitalized during treatment and receive antibiotics and antivirals afterward if needed. Follow-up visits occur every 1-3 months for the first year and then every 6 months. Researchers track tumor response rates at multiple time points after cell infusion, monitor side effects, and assess overall survival. The total participation may last several years, allowing careful evaluation of treatment outcomes and safety.

A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab