A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100)

• Status: Completed
• Trial end date: 2019-10-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Avelumab; Axitinib

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).