Status:
COMPLETED
Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Metastatic Malignant Neoplasm in the Liver
Metastatic Uveal Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ip...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the clinical benefit of treatment with immunoembolization (IEMBO) in combination with ipilimumab and nivolumab. SECONDARY OBJECTIVES: I. Determine all treatment and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03472586
Start Date
May 2 2018
End Date
December 31 2024
Last Update
April 24 2025
Active Locations (1)
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1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107