Virginia Commonwealth University
Randomized, 2-arm, non-comparative, pilot study assessing the efficacy of cemiplimab with or without fianlimab after treatment with yttrium-90 (Y90).
At 2-8 weeks after yttrium-90 (Y90) radioembolization, patients will be randomized to receive treatment with cemiplimab or with a fixed-dose combination of cemiplimab and fianlimab. If Y90 is administered in 2 treatments, the first dose of the study treatment must be given no more than 12 weeks after first Y90 treatment and at least 2 weeks after the second treatment. Patients will receive the assigned study treatment once per 3-week cycle and will continue treatment for up to 17 cycles (approximately 1 year) or until disease progression or intolerance.
Inclusion Criteria: * Diagnosis of hepatocellular carcinoma (HCC) in the liver by radiographic imaging or histology * Eligible for yttrium-90 (Y90) treatment by the following definition: Patients must have lung dose threshold for Y90 glass microspheres of 30 Gy (≤ 30 Gy per treatment for glass) and an estimated future liver remnant volume (FLRV) ≥ 30% of whole liver volume * Age ≥18 years * Disease in the liver measurable by modified Response Evaluation Criteria in Solid Tumors (mRECIST) * Child Pugh Scale Score A-B7 * Not eligible for (according to the practice of the treating institution)…
Cemiplimab 350mg IV every 3 weeks up to 1 year.
Cemiplimab 350mg IV and fianlimab 1600mg every 3 weeks up to 1 year
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