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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-72 lata
- •Czerniak przerzutowy skóry, możliwy do pobrania do hodowli
- •Wcześniejsze leczenie czerniakiem przerzutowym
- •Podpisana świadoma zgoda na uczestnictwo w badaniu
- •Gotowość do stosowania antykoncepcji przez 4 miesiące od leczenia
- •Ujemne wyniki na HIV, wirusowe zapalenie wątroby B i C
- •Zdolność do wykonywania codziennych czynności (stan ogólny 0-1)
✗ Disqualifies
- •Przerzuty do mózgu większe niż 1 cm lub objawiające się (z wyjątkami opisanymi w kryteriach)
- •Ciąża lub karmienie piersią
- •Zakaźne choroby (HIV, wirusowe zapalenie wątroby)
- •Brak możliwości pobrania tkanki guza do hodowli komórek
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 72 Years
- Last updated (source)
- August 20, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
National Institutes of Health Clinical Center
Bethesda, United States
Trial contact
NCI/Surgery Branch Recruitment Center
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/15/2026.
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