Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma

This study is testing a treatment for metastatic uveal melanoma (a type of eye cancer that has spread) using your own immune cells. The treatment involves taking your tumor cells, growing specific immune cells called Tumor Infiltrating Lymphocytes (TIL) from them, and then giving these TIL back to you intravenously (through a vein). This is followed by a medication called aldesleukin. The goal is to see how many patients experience a reduction in their tumor size (Objective Response Rate). This treatment is a type of immunotherapy, which uses your body's own immune system to fight cancer. You may be eligible if you are between 18 and 75 years old, have measurable metastatic uveal melanoma, and can have a tumor removed to create the TIL cells. The study is currently unclear on its recruitment status.

Study design: This is a Phase 2 interventional study planning to enroll 34 participants. It is a single-arm study, meaning all participants receive the same treatment.
What's involved: You would undergo a procedure to remove a tumor, have your immune cells prepared, and then receive the TIL infusion and aldesleukin. Specific details on the number of visits or overall duration are not provided.
Compensation: Not stated in the trial record.
Follow-up: Your response to treatment will be measured for up to 24 months after the TIL infusion.

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

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma

Active, Not Recruiting

PHASE2Ages 18–75InterventionalTreatment

Udai Kammula

~34 participants

Updated 2026-06-01 on ClinicalTrials.gov

What's tested:Tumor Infiltrating Lymphocytes (TIL)

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Objective Response Rate (ORR)

Measured over Post TIL infusion, up to 24 months (measurements taken at 6 weeks, 12 weeks, 6 months, 9 months, 12 months, 18 months 24 months)

Conditions

Uveal Neoplasms

Melanoma, Uveal

Where it's being run

1 sites across 1 states

Pennsylvania1

Study leadership

Udai S Kammula, MD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Measurable metastatic uveal melanoma.

Patients must be co-enrolled on the companion protocol HCC 17-220 (Cell Harvest and Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical Studies) and have available TIL cultures for therapy.

Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.

Greater than or equal to 18 years of age and less than or equal to age 75

Able to understand and sign the Informed Consent Document

Clinical performance status of ECOG 0 or 1

Life expectancy of greater than three months

Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the treatment.

Serology:

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 be 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.

Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus.

Hematology

Absolute neutrophil count greater than 1000/mm3 without the support of filgrastim

WBC ≥ 3000/mm3

Platelet count ≥ 100,000/mm3

Hemoglobin \> 8.0 g/dl

Chemistry

Serum ALT/AST ≤ to 3.5 times the upper limit of normal

Serum creatinine ≤ to 1.6 mg/dl

Total bilirubin ≤ to 2.0 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.

More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a clinically manageable level (except for toxicities such as alopecia or vitiligo). (Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less)

Exclusion

Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.

Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).

Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses.

History of clinically significant major organ autoimmune disease

Concurrent systemic steroid therapy.

History of severe immediate hypersensitivity reaction to any of the agents used in this study.

History of active coronary or ischemic symptoms.

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.

Documented FEV1 less than or equal to 60% predicted tested in patients with:

A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2 years).

Symptoms of respiratory dysfunction

Patients who are receiving any other investigational agents.

What this trial measures

Objective Response Rate (ORR)Post TIL infusion, up to 24 months (measurements taken at 6 weeks, 12 weeks, 6 months, 9 months, 12 months, 18 months 24 months)
The proportion of patients with response per RECIST for a (minimum) time period. Equation: #patients with CR + #patients with PR / #patients with CR + #patients with PR + #patients with SD + #patients with PD

Trialytics