This phase Ib/II trial studies the best dose and side effects of siltuximab and how well it
works in combination with spartalizumab in treating patients with pancreatic cancer that has
spread to other places in the body. Monoclonal antibodies, such as siltuximab and
spartalizumab, interfere with the ability of tumors cells to grow and spread.
I. Determine the recommended phase II dose for the combination of spartalizumab and
I. Define the toxicity profile of the combination of the recommended phase II dose of
spartalizumab and siltuximab.
II. Evaluate the activity of the combination of spartalizumab and siltuximab in previously
treated patients with pancreatic cancer.
I. Evaluate the effect of the combination on the immune profile in the serum and in tumor
OUTLINE: This is a dose-escalation study of siltuximab.
Participants receive spartalizumab intravenously (IV) over 30 minutes on day 1 and siltuximab
IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or
After completion of study treatment, participants are followed up at 30, 60, 90, 120, and 150
days, then every 12 weeks thereafter.
Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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