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Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy

This study is testing an experimental cancer treatment for metastatic melanoma (skin cancer that has spread). It uses a cell therapy called young tumor infiltrating lymphocytes (TIL), which are your own immune cells grown in a lab to fight cancer. These cells are given along with Aldesleukin (a drug that boosts immune cells) and a preparatory regimen of Fludarabine and Cyclophosphamide. Researchers are investigating if adding Pembrolizumab (a drug that helps your immune system recognize cancer) makes this cell therapy more effective at shrinking tumors. You could be eligible if you are 18-72 years old with metastatic melanoma and have had at least one prior treatment. The main goal is to see how many people respond to the treatment.

Study design
This is an interventional study with a planned enrollment of 53 participants. It is designed to determine the objective response rate to the treatments.
What's involved
You would undergo screening tests including physical exams, scans (CT, MRI, PET), X-rays, and blood/urine tests. A tumor biopsy and leukapheresis (a procedure to collect blood cells) are also required before treatment.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured at 6 and 12 weeks after cell infusion, then every 3 months for 9 months, and then every 6 months for 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE2Ages 18–72InterventionalTreatment
National Cancer Institute (NCI)
~53 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:young TILPembrolizumabAldesleukinFludarabineCyclophosphamide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response rate
Measured over 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years

Conditions

Melanoma

Explore related trials

Melanoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Stephanie L Goff, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

NCI/Surgery Branch Recruitment Center
[email protected]
(866) 820-4505
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus are less responsive to the experimental treatment and more susceptible to its toxicities.)
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative. 11. Individuals of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus. 12. Individuals of child-bearing potential (IOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \[IUD, abstinence, surgical sterilization starting at the time of study entry, for the duration of study therapy, and 12 months after the last dose of combined chemotherapy
Absolute neutrophil count greater than 1000/mm3 without the support of filgrastim/biosimilar
WBC greater than or equal to 2500/mm3
Platelet count greater than or equal to 800,000/mm3
Hemoglobin \> 8.0 g/dl 15. Chemistry
Serum ALT/AST less than or equal to 2.5 times ULN
Serum Creatinine less than or equal to 1.6 mg/dl
Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL. 16. Patients must have completed any prior systemic therapy at the time of enrollment. 17. Patients must demonstrate progressive disease at the time of treatment. (Note: Patients who have received tyrosine kinase inhibitors (e.g. vemurafinib) may be treated if they present with stable disease at the time of treatment). 18. Patients must be co-enrolled in protocol 03-C-0277.

What this trial measures

  • Response rate6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years

    Percentage of patients who have a clinical response to treatment (objective tumor regression)