A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100)
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Avelumab (MSB0010718C); Axitinib (AG-013736)
Intervention description: Patients will receive avelumab 10 mg/kg Q2W in combination with axitinib 5 mg BID.; Patients will receive avelumab 10 mg/kg Q2W in combination with axitinib 5 mg BID.
Intervention MeSH terms: Avelumab; Axitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Cancer; Hepatocellular carcinoma; Liver disease; Avelumab; Axitinib

Summary:

      To evaluate the safety, efficacy and PK of avelumab in combination with axitinib as first
      line treatment in patients with advanced HCC
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of locally advanced or metastatic HCC, obtained by histology/cytology (on a
             prior tumor biopsy) or by imaging with serum α-fetoprotein (AFP) ≥400 ng/mL.

          -  All patients must provide at least 1 archival tumor specimen. If archival tumor
             specimen is no longer available, de novo tumor biopsy will be required during
             screening.

          -  HCC not amenable to local therapy.

          -  Measurable disease according to RECIST v. 1.1.

          -  Child Pugh Class A disease.

          -  BCLC stage B or C disease.

          -  No evidence of uncontrolled hypertension as documented by 2 baseline blood pressure
             readings taken at least 1 hour apart.

          -  ECOG performance status 0 or 1.

          -  Adequate bone marrow function, renal and liver functions

          -  Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (LLN) as assessed by
             multigated acquisition (MUGA) scan or echocardiogram (ECHO).

        Exclusion Criteria:

          -  Prior systemic treatment for advanced HCC, including prior treatment with approved or
             investigational drugs.

          -  Any prior locoregional therapy within 4 weeks and radiotherapy or surgical procedure
             within 2 weeks (4 weeks for major surgery) of enrollment.

          -  Patients with known symptomatic brain metastases requiring steroids.

          -  Presence of hepatic encephalopathy (ie, Child Pugh score of 2 or 3) and/or clinically
             relevant ascites (ie, Child Pugh score of 3).

          -  Presence of main portal vein invasion by HCC.

          -  Any of the following within the 12 months prior to enrollment: myocardial infarction,
             severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic
             congestive heart failure, LVEF less than LLN, clinically significant pericardial
             effusion, cerebrovascular accident, transient ischemic attack.

          -  Active infection requiring systemic therapy except for hepatitis C virus (HCV) and
             hepatitis B virus (HBV).