OncoMatch/Clinical Trials/NCT03467516
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma
Is NCT03467516 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tumor Infiltrating Lymphocytes (TIL) for uveal neoplasms.
Treatment: Tumor Infiltrating Lymphocytes (TIL) — This is a Phase 2 study in which the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in patients with metastatic uveal melanoma will be evaluated. Metastatic uveal melanoma (UM) carries a poor prognosis with estimated survival of 4-6 months. There are no known effective systemic therapies. Metastatic UM is classified as an "orphan" disease and there are currently few clinical trial options for these patients. Thus, novel systemic approaches are desperately needed. A recent pilot study has found that administration of autologous tumor infiltrating lymphocytes (TIL) generated from resected metastases can induce objective tumor response and durable complete response in metastatic uveal melanoma patients. These encouraging results require confirmation to determine if this immunotherapy is of future benefit in treating this disease.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
ANC > 1000/mm3 without filgrastim; WBC ≥ 3000/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin > 8.0 g/dl
Kidney function
Serum creatinine ≤ 1.6 mg/dl
Liver function
Serum ALT/AST ≤ 3.5x ULN; total bilirubin ≤ 2.0 mg/dl (except Gilbert's Syndrome <3.0 mg/dl)
Cardiac function
LVEF > 45% required in patients >65 years or with arrhythmias/ischemic heart disease/chest pain
Hematology: ANC > 1000/mm3 without filgrastim; WBC ≥ 3000/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin > 8.0 g/dl. Chemistry: Serum ALT/AST ≤ 3.5x ULN; Serum creatinine ≤ 1.6 mg/dl; Total bilirubin ≤ 2.0 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin <3.0 mg/dl. Documented LVEF of less than or equal to 45%; note: testing is required in patients with: Age > 65 years old; Clinically significant atrial and or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or have a history of ischemic heart disease, chest pain.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UPMC Hillman Cancer Center · Pittsburgh, Pennsylvania
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