Overview

A Prospective Randomized and 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

Status:
Suspended

Trial end date:
2026-06-16

Target enrollment:

Participant gender:

Summary

Background: Cell therapy is an experimental cancer therapy. It takes young tumor infiltrating lymphocytes (Young TIL) cells from a person s tumors and grows them in a lab. Then they are returned to the person. Researchers think adding the drug pembrolizumab might make the therapy more effective. Objective: To test if adding pembrolizumab to cell therapy is safe and effective to shrink melanoma tumors. Eligibility: People ages 18 70 years with metastatic melanoma Design: Participants will be screened with: Physical exam CT, MRI, or PET scans X-rays Heart and lung function tests Blood and urine tests Before treatment, participants will have: A piece of tumor taken from a biopsy or during surgery in order to grow TIL cells Leukapheresis: Blood flows through a needle in one arm and into a machine that removes white blood cells. The rest of the blood returns through a needle in the other arm. An IV catheter placed in the chest for getting TIL cells, aldesleukin, and pembrolizumab (if assigned) Participants will stay in the hospital for treatment. This includes: Daily chemotherapy for 1 week For some participants, pembrolizumab infusion 1 day after chemotherapy TIL cell infusion 2 4 days after chemotherapy, then aldesleukin infusion every 8 hours for up to 12 doses Possible filgrastim injection Recovery for 1 2 weeks After treatment, participants will: Take an antibiotic and antiviral for at least 6 months If assigned, have pembrolizumab treatment every 3 weeks for 3 more doses. They may have another round. Have 2-day follow-up visits every 1 3 months for 1 year and then every 6 months

Phase:

Phase 2

Details

Lead Sponsor:

National Cancer Institute (NCI)

Treatments:

Cyclophosphamide
Fludarabine
Fludarabine phosphate
Pembrolizumab