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• W2890862870 abstract "TPS4146 Background: Emerging preclinical and clinical data indicate that regional therapies impact the immune microenvironment, induce a peripheral immune response, and may augment the effects of immune checkpoint blockade. Given the activity of NIVO in the metastatic setting, we propose to test the safety of NIVO at earlier stages of HCC (BCLC-B) as an adjuvant therapy to TACE. Methods: This is a multicenter phase 1 study of the combination of NIVO and deb-TACE in unresectable HCC pts (BCLC Stage B) who are not candidates for curative treatment and have Child Pugh A hepatic function (NCT03143270). The primary objectives are to assess the safety, tolerability, and to define the optimal dosing schedule of the combination. A modified 3 + 3 design will sequentially treat pts with differing schedules of NIVO relative to deb-TACE. For all cohorts, deb-TACE (loaded with 75mg of doxorubicin) is administered on Day 0. NIVO is dosed at 240mg IV every 14 days for 1 year. In Cohort 1, NIVO is administered beginning on day +14 after deb-TACE. In Cohort 2, interrupted NIVO dosing begins at Day -28 but is held on the Day 0 at the time of deb-TACE, then restarted on Day +14. In cohort 3, continuous NIVO dosing begins on Day -28 without interruption during deb-TACE. If limiting toxicities occur in ≤33% of each cohort; cohort 3 will be defined as the recommended schedule for this combination. This cohort will then be expanded to a total of 16 pts. Cross-sectional imaging is completed at baseline, 1 month post-embolization, and every 3 months until disease progression, intolerable toxicities, or consent withdrawal. Secondary endpoints include overall response rate by modified Response Evaluation Criteria in Solid Tumors (RECIST) and RECIST v1.1, time to progression, progression-free and overall survival. Correlative objectives include sequential whole blood sampling and biopsies (pretreatment, on-treatment, at progression) to define mechanisms of anti-PD-1 resistance and to explore the effect of different schedules of treatment on the immune environment. Up to 28 pts will enroll at 4 sites over a 2 year period. Cohorts 1 and 2 have completed enrollment as of February 2018. Clinical trial information: NCT03143270." @default.
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• W2890862870 date "2018-05-20" @default.
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• W2890862870 title "A multicenter pilot study of nivolumab (NIVO) with drug eluting bead transarterial chemoembolization (deb-TACE) in patients (pts) with liver limited hepatocellular carcinoma (HCC)." @default.
• W2890862870 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.tps4146" @default.
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