Durable complete responses in heavily pretreated patients with metastatic melanoma using T-cell transfer immunotherapy.
Steven A Rosenberg, James C Yang, Richard M Sherry...
https://pubmed.ncbi.nlm.nih.gov/21498393Actively Recruiting
Phase 2
Age: 18Years - 72Years
All Genders
ID02621021
A Phase II 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 2026-06-08
53
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment for metastatic melanoma that combines adoptive cell therapy using tumor infiltrating lymphocytes (TIL) with high-dose interleukin-2 (IL-2), either alone or with the drug pembrolizumab. The study focuses on whether adding pembrolizumab can improve tumor shrinkage and safety in patients who have previously received anti-PD-1/PD-L1 therapy. This phase 2 trial includes patients aged 18 to 72 with measurable metastatic melanoma that can be surgically removed to grow TIL cells. Participants undergo a preparative regimen with chemotherapy drugs cyclophosphamide and fludarabine before receiving TIL cells intravenously. Some participants receive pembrolizumab infusions before and after the cell therapy. High-dose IL-2 is given every 8 hours for up to 12 doses following cell infusion. The treatment involves daily chemotherapy for one week, TIL infusion 2-4 days later, and supportive injections to help blood counts recover. Depending on group assignment, pembrolizumab is given on a schedule around the cell infusion. The study includes multiple treatment arms based on prior therapy and pembrolizumab eligibility. During the study, participants have tumor biopsies, blood tests, imaging scans, and heart and lung function tests. They remain hospitalized during treatment and receive antibiotics and antivirals afterward if needed. Follow-up visits occur every 1-3 months for the first year and then every 6 months. Researchers track tumor response rates at multiple time points after cell infusion, monitor side effects, and assess overall survival. The total participation may last several years, allowing careful evaluation of treatment outcomes and safety.
CONDITIONS
Brief 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
Age: 18Years - 72Years
All Genders
Eligibility Criteria
You may qualify if you...
- Measurable metastatic melanoma with at least one lesion suitable for surgical removal to grow TIL cells
- Diagnosis of metastatic melanoma confirmed by pathology
- Age between 18 and 72 years
- Received at least one prior therapy for metastatic melanoma
- Up to 3 brain metastases less than 1 cm in diameter and asymptomatic, or surgically resected brain metastases
- Signed informed consent and willing to sign durable power of attorney
- ECOG performance status of 0 or 1
- Willing to use birth control from enrollment through 4 months after treatment if of child-bearing potential
- Seronegative for HIV antibody, hepatitis B antigen, and hepatitis C antibody (with additional testing if needed)
- Willingness to undergo pregnancy testing if applicable
- Hematology values within defined limits (e.g., neutrophils >1000/mm3, WBC ≥2500/mm3, platelets ≥800,000/mm3, hemoglobin >8.0 g/dl)
- Chemistry values within defined limits (e.g., ALT/AST ≤2.5x ULN, creatinine ≤1.6 mg/dl, bilirubin ≤1.5 mg/dl except Gilbert's Syndrome)
- Completed prior systemic therapy
- Demonstrated progressive disease at treatment time (except stable disease if on certain kinase inhibitors)
- Co-enrollment in protocol 03-C-0277
You will not qualify if you...
- Pregnant or nursing individuals of child-bearing potential
- Primary immunodeficiency disorders
- Opportunistic infections or active systemic infections requiring treatment
- Coagulation disorders or other active major medical illnesses
- History of major organ autoimmune disease
- Concurrent systemic steroid therapy
- History of severe immediate hypersensitivity to study agents
- Grade 3 or 4 major organ immune-related adverse events from prior anti PD-1/PD-L1 therapy (except thyroid)
- History of coronary revascularization or ischemic symptoms
- Left ventricular ejection fraction ≤45% if cardiac evaluation indicated
- Forced expiratory volume in 1 second (FEV1) ≤50% if pulmonary evaluation indicated
- Receiving any other investigational agents at enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Non-myeloablative Conditioning
Duration - 5 days
Participants receive a preparative regimen of cyclophosphamide and fludarabine prior to cell therapy.
5 daily visits for drug administration
Adoptive Cell Therapy with Tumor-Infiltrating Lymphocytes (TIL) and High-Dose IL-2 Treatment
Duration - Up to 5 days following cell infusion
Participants receive an infusion of young TIL cells followed by high-dose aldesleukin (IL-2) to stimulate immune response.
1 infusion visit plus up to 12 IL-2 doses administered approximately every 8 hours over 4 days
Pembrolizumab Treatment (for applicable cohorts)
Duration - Approximately 9 weeks following cell infusion
Participants receive pembrolizumab starting before TIL infusion and continuing for three additional cycles to enhance anti-tumor activity.
4 infusions on day -2, and days 21, 42, and 63 after cell infusion
Follow-up and Monitoring
Duration - Up to 2 years following treatment
Participants are monitored for treatment response and safety, including tumor response assessments and adverse event evaluations.
Visits at 6 and 12 weeks after cell infusion, then every 3 months for 9 months, then every 6 months for 2 years
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
N
NCI/Surgery Branch Recruitment Center
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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Published Research Related To This Trial
Pembrolizumab versus Ipilimumab in Advanced Melanoma.
Caroline Robert, Jacob Schachter, Georgina V Long...
https://pubmed.ncbi.nlm.nih.gov/25891173Adoptive transfer of tumor-infiltrating lymphocytes in patients with metastatic melanoma: intent-to-treat analysis and efficacy after failure to prior immunotherapies.
Michal J Besser, Ronnie Shapira-Frommer, Orit Itzhaki...
https://pubmed.ncbi.nlm.nih.gov/23690483