LIVER CANCER: Unresectable: Child\'s A: First-Line: Immunotherapy: HIMALAYA

A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma

Title
AstraZeneca D419CC00002 (HIMALAYA HCC)
Study Title

A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma

Site Link
Malignancy
Liver cancer, Hepatocellular cancer: HCC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st Line
Investigational Agent
Tremelimumab, durvalumab
Drug Class
CTLA-4 inhibitor, PD-L1 inhibitor
PI
Brad Somer, MD
Sponsor
AstraZeneca
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Confirmed pathologic diagnosis of HCC (from tumor tissue)
  • Must not be eligible for locoregional therapy for unresectable HCC. Patients who progressed on local regional therapy are eligible if therapy was >28 days prior
  • Barcelona Clinic Liver Cancer (BCLC) stage B or stage C
  • Child-Pugh Score class A
  • ECOG PS 0-1
  • HBV or HCV may be allowed depending on activity (may not have both together)
  • Measurable disease
  • No prior receipt of durvalumab, tremelimumab, or sorafenib
  • No prior receipt of any PD-1, PD-L1, or CTLA-4 antibody
  • No autoimmune disease within the last 5 years
  • No CNS mets
  • No fibrolamellar or sarcomatoid HCC or mixed cholagiocarcinoma with HCC
  • No recent steroid use (>10 mg prednisone/day)
Objective

Primary- OS:  Secondary- TTP, PFS, ORR, DCR, DoR, PK, QoL

Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
Hepatocellular carcinoma
Dosing Frequency
Control Agents
sorafenib
Study Protocol
Randomized
Yes
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