Double immunotherapy plus liver blockade targets eye cancer that spreads
NCT ID NCT03472586
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This trial investigates whether combining two immunotherapy drugs (ipilimumab and nivolumab) with a procedure called immunoembolization can help people whose uveal melanoma has spread to the liver. The drugs help the immune system attack cancer cells, while immunoembolization cuts off the blood supply to liver tumors and may also trigger an immune response. The study includes people with at least one measurable liver metastasis and aims to see if this combination can stabilize or shrink liver tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ipilimumab and nivolumab (immunotherapy drugs) plus immunoembolization (a procedure that blocks blood flow to liver tumors)
- What this could lead to
- If it works, this combination could offer a new way to control liver metastases from uveal melanoma, potentially slowing or stopping tumor growth.
- What could go wrong
- This is a small, early-phase trial with only 14 participants. The added drugs and procedure may cause serious side effects, and the approach may not work for everyone.
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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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14 people
The number who actually took part.
- Started
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May 2018
- Finished
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Dec 2024
- 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 years and older
- 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: * Histologically confirmed metastatic uveal melanoma in the liver; patients must have at least one measurable liver metastasis that is \>= 10 mm in longest diameter by computed tomography (CT) scan or magnetic resonance imaging (MRI) * The total volume of the tumors must be less than 50% of the liver volume * Willingness and ability to give informed consent * Agreement to access archival tissue or agreement for tumor biopsy prior to treatment * Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1 * Serum creatinine =\< 2.0 mg/dl * Granulocyte count \>= 1000/mm\^3 * Platelet count \>= 100,000/mm\^3 * Bilirubin =\< 2.0 mg/ml * Albumin \>= 3.0 g/dl * Prothrombin time (PT)/partial thromboplastin time (PTT) less than 1.5 times normal * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 x upper limit of normal (ULN) * Alkaline phosphatase less than 1.5 times ULN (grade 1) * Women must not be pregnant or breast-feeding * Women of child-bearing potential must use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for at least 23 weeks after the last dose of nivolumab and/or ipilimumab and sexually active males must use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for at least 31 weeks after the last dose of nivolumab and/or ipilimumab Exclusion Criteria: * Failure to meet any of the criteria set forth in the inclusion criteria section * Previous systemic exposure to anti-CTLA-4 antibody or anti-PD1 antibody * Previous liver-directed treatments including chemoembolization, radiosphere, hepatic arterial perfusion, or drug-eluting beads; liver resection and focal ablation are permitted * Presence of symptomatic liver failure including ascites and hepatic encephalopathy * Presence of untreated brain metastases; if patients have had previous treatment for the brain metastasis, an MRI or CT scan of the brain must confirm the stabilization of the brain metastasis for more than 2 months * Presence of uncontrolled hypertension or congestive heart failure, or acute myocardial infarction within 6 months of entry * Presence of any other medical complication that implies survival of less than six months * Uncontrolled severe bleeding tendency or active gastrointestinal (GI) bleeding * Significant allergic reaction to contrast dye or granulocyte-macrophage colony-stimulating (GM-CSF) * Immunosuppressive treatments within 4 weeks prior to embolization, unless prednisone =\< 5 mg or equivalent * Pregnancy or breast-feeding women * Patients with active hepatitis with serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) equal or greater than 5 times normal * Biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy * Positive for known human immunodeficiency virus (HIV) Infection * Uncontrolled chronic obstructive pulmonary disease or previous known pulmonary fibrosis * Active infection * Auto-immune disease including inflammatory bowel disease, lupus, rheumatoid arthritis, but not including hypothyroidism or psoriasis if condition has been stable for 2 months or greater
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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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Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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Other studies related to the condition(s) this trial covers.
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