OncoMatch/Clinical Trials/NCT02621021
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
Is NCT02621021 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for melanoma.
Treatment: young TIL · Pembrolizumab · Aldesleukin · Fludarabine · Cyclophosphamide — 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...
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
ANC > 1000/mm3 without filgrastim; WBC ≥ 2500/mm3; Platelet count ≥ 800,000/mm3; Hemoglobin > 8.0 g/dl
Kidney function
Serum creatinine ≤ 1.6 mg/dl
Liver function
Serum ALT/AST ≤ 2.5x ULN; total bilirubin ≤ 1.5 mg/dl (except Gilbert's ≤ 3.0 mg/dl)
Hematology: Absolute neutrophil count > 1000/mm3 without the support of filgrastim; WBC ≥ 2500/mm3; Platelet count ≥ 800,000/mm3; Hemoglobin > 8.0 g/dl. Chemistry: Serum ALT/AST ≤ 2.5x ULN; Serum Creatinine ≤ 1.6 mg/dl; Total bilirubin ≤ 1.5 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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