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 18-72 years with metastatic melanoma OF THE SKIN
Design:
Participants will be screened with:
Physical exam
CT, MRI, or PET scans
X-rays
Heart and lung function tests if indicated
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
Filgrastim injections to help restore your blood counts
Recovery for 1-3 weeks
After treatment, participants will:
Take an antibiotic and an antiviral for at least 6 months, as applicable
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
Measurable metastatic melanoma with at least one lesion that is resectable for TIL generation.
Confirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of NCI.
Patients must have received at least one prior therapy for metastatic melanoma.
Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.
Individuals of child-bearing potential who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.
Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
Active systemic infections requiring anti-infective treatment, coagulation disorders or any other active major medical illnesses.