NCT03472586CompletedPhase 2
Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver
Ipilimumab and Nivolumab in Combination With Immunoembolization for the Treatment of Metastatic Uveal Melanoma
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
This phase II trial studies ipilimumab and nivolumab with immunoembolization in treating patients with uveal melanoma that has spread to the liver. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunoembolization may kill tumor cells due to loss of blood supply and develop an immune response against tumor cells. Giving ipilimumab and nivolumab with immunoembolization may work better in treating patients with uveal melanoma.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 14 Mar 2018
- Start date
- 2 May 2018
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Diseases
- Melanoma
- NCT number
- NCT03472586
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 14
- From 2 May 2018 to the primary completion date, 31 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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
- Immunosuppressive treatments within 4 weeks prior to embolization, unless prednisone =\< 5 mg or equivalent
- Biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy
- Uncontrolled chronic obstructive pulmonary disease or previous known pulmonary fibrosis
Other illness
- Failure to meet any of the criteria set forth in the inclusion criteria section
- Presence of symptomatic liver failure including ascites and hepatic encephalopathy
- Presence of uncontrolled hypertension or congestive heart failure, or acute myocardial infarction within 6 months of entry
- Uncontrolled severe bleeding tendency or active gastrointestinal (GI) bleeding
- Significant allergic reaction to contrast dye or granulocyte-macrophage colony-stimulating (GM-CSF)
- Positive for known human immunodeficiency virus (HIV) Infection
- 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
Lab values
- Patients with active hepatitis with serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) equal or greater than 5 times normal
Other
- Presence of any other medical complication that implies survival of less than six months
- Pregnancy or breast-feeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.