Actively Recruiting
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
Led by National Cancer Institute (NCI) · Updated on 2026-05-08
170
Participants Needed
1
Research Sites
706 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Measurable metastatic melanoma with at least one lesion suitable for TIL generation by surgery
- Confirmed diagnosis of metastatic melanoma by NCI Laboratory of Pathology
- Patients must have received at least one prior therapy for metastatic melanoma
- Patients with up to 3 asymptomatic brain metastases less than 1 cm or with stable treated brain lesions
- Age between 18 and 72 years
- Must sign written informed consent and durable power of attorney
- ECOG performance status 0 or 1
- Willingness to practice birth control during and up to 4 months after treatment
- Seronegative for HIV antibody
- Seronegative for hepatitis B antigen and hepatitis C antibody; if positive for hepatitis C antibody, must be HCV RNA negative
- Individuals of child-bearing potential must agree to pregnancy testing and use effective contraception during and after treatment
- Nursing participants must agree to discontinue nursing from study start through 4 months after last study drug
- Adequate hematology: neutrophils >1000/mm3, WBC ≥2500/mm3, platelets ≥800,000/mm3, hemoglobin >8.0 g/dl
- Adequate chemistry: ALT/AST ≤2.5x ULN, creatinine ≤1.6 mg/dl, total bilirubin ≤1.5 mg/dl (or ≤3.0 mg/dl with Gilbert's Syndrome)
- Completed any prior systemic therapy before enrollment
- Patients must show progressive disease or stable disease if previously treated with tyrosine kinase inhibitors
- Co-enrollment in protocol 03-C-0277
You will not qualify if you...
- Pregnant or nursing individuals of child-bearing potential
- Any primary immunodeficiency disorder
- Concurrent opportunistic infections
- Active systemic infections needing treatment, coagulation disorders, or other major medical illnesses
- History of major organ autoimmune disease
- Current systemic steroid therapy
- History of severe allergic reaction to study agents
- Grade 3 or 4 major organ immune-related adverse events from anti-PD-1/PD-L1 therapy (except thyroid)
- History of coronary revascularization or ischemic symptoms
- Cardiac evaluation showing left ventricular ejection fraction ≤45%
- Pulmonary function showing FEV1 ≤50%
- Use of any other investigational agents
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI/Surgery Branch Recruitment Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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