Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver

Launched by SIDNEY KIMMEL CANCER CENTER AT THOMAS JEFFERSON UNIVERSITY · Mar 14, 2018

Keywords

ClinConnect Summary

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 immune related toxicities. II. Determine progression free survival. III. Determine overall survival.

Gender

ALL

Eligibility criteria

• 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