Immune cell therapy shows promise against rare eye cancer
NCT ID NCT03467516
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether a patient's own immune cells, called tumor-infiltrating lymphocytes (TIL), can shrink tumors in people with metastatic uveal melanoma, a rare and aggressive eye cancer. Participants receive chemotherapy to prepare their immune system, then an infusion of their own TIL cells followed by high-dose aldesleukin (IL-2). The study aims to confirm earlier promising results showing tumor shrinkage and durable responses in some patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tumor Infiltrating Lymphocytes (TIL) plus high-dose aldesleukin (IL-2)
- What this could lead to
- If successful, this could offer a new treatment option for a rare and aggressive eye cancer that currently has no effective standard therapy.
- What could go wrong
- This is a small, early-phase trial (34 patients) and the treatment involves intensive chemotherapy and high-dose IL-2, which can cause serious side effects. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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34 people
The number who actually took part.
- Started
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May 2018
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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Other studies related to the condition(s) this trial covers.
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