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Title:
J1891 - A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients with Unresectable Hepatocellular Carcinoma (HIMALAYA)
Protocol Number:
J1891
Phase:
Phase III
Physician:
Mark Yarchoan
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC.
Eligibility:
Inclusion criteria •HCC based on histopathological confirmation •No prior systemic therapy for HCC •Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C •Child-Pugh Score class A •ECOG performance status of 0 or 1 at enrollment Exclusion criteria •Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy •Clinically meaningful ascites •Main portal vein tumor thrombosis •Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months •HBV and HVC co-infection, or HBV and Hep D co-infection
Treatment:
This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy. The study population includes patients 18 years of age or older with advanced HCC, Barcelona Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh A classification liver disease. Patients must not have received any prior systemic therapy for unresectable HCC. Patients in all treatment arms may continue receiving their originally assigned treatment, at the Investigator's discretion, until progression Patients in all arms with confirmed PD who, in the Investigator's opinion, continue to receive benefit from their assigned treatment and meet the criteria for treatment in the setting of PD may continue to receive their assigned treatment. If a patient discontinues study drug(s) due to disease progression, the patient will enter survival follow-up. Patients who have discontinued treatment due to toxicity or symptomatic deterioration or who have commenced subsequent anticancer therapy, will have tumor assessments until confirmed PD and will be followed for survival.
Population:
Adult
Last Update
03/05/2019 05:03 AM