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Title:
J17136: Feasibility and Efficacy of Neoadjuvant Cabozantinib plus Nivolumab (CaboNivo) Followed by Definitive Resection for Patients with Locally Advanced Hepatocellular Carcinoma (HCC)
Protocol Number:
J17136
Phase:
Phase I
Physician:
Mark Yarchoan
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The purpose of this Phase 1b study is to determine the safety and tolerability of neoadjuvant (given before surgery) cabozantinib plus nivolumab in patients with locally advanced hepatocellular carcinoma (HCC).
Eligibility:
Patients must be 18 years old or over with ECOG performance status 0-1 as determined by study team. Patients must have locally advanced/borderline resectable HCC (no fibrolamellar or mixed histology HCC permitted) and measurable disease per protocol. Patients must not have received any prior systemic chemotherapy, investigational agents or palliative local therapy (TACE, Y90 microspheres, etc.). Prior surgical resection with recurrence is permitted but must have been more than 6 months ago. NO oral anticoagulant therapy at therapeutic doses. NO clinically significant GI bleeding within 6 months or signs of pulmonary hemorrhage. NO history of HIV/AIDS or active co-infection with HBC and HCV or HBV and HDV. NO immunodeficiency or immunosuppressive therapy. NO active autoimmune disease requiring systemic treatment in past 2 years. NO uncontrolled intercurrent illness or psychiatric/social situations that would limit compliance with study requirements. NO poorly controlled hypertension. NO GI disorders including those associated with a high risk of perforation or fistula formation. NO major surgery within 2 months before enrollment. NO moderate or severe ascites. NO untreated/incompletely treated varices with bleeding or high risk for bleeding. NO chronic treatment with strong CYP3A4 inducers. Must be able to swallow intact tablets. Other inclusion/exclusion criteria as specified per protocol.
Treatment:
Treatment will be administered on an outpatient basis. Cabozantinib will be taken orally once daily and nivolumab will be given IV over 60 minutes once every 2 weeks.
Population:
Adult
Last Update
03/05/2019 05:03 AM