TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer

This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory stomach and esophageal cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has shown significant promise in treating unresectable or metastatic melanoma by leveraging the patient's own immune cells to target and destroy cancer cells. This study aims to apply a similar approach to stomach and esophageal cancers. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody that targets the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.

NCT Number	NCT06532799
Lead Sponsor	Essen Biotech
Conditions	Stomach Cancer, Stomach Cancer Recurrent, Stomach Cancer, Adenocarcinoma, Esophageal Cancer, Esophageal Cancer Metastatic to Bone, Esophageal Cancer Metastatic to Lung, Esophageal Cancer Metastatic to Liver
Enrollment	75 participants
Start Date	2024-09-10
Primary Completion	2025-12-15 (estimated)
Study Completion	2026-12-28 (estimated)
Updated on ClinicalTrials.gov	2024-11-12