Status:
COMPLETED
A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100)
Lead Sponsor:
Pfizer
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief 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
- 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
- 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).
Key Trial Info
Start Date :
September 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03289533
Start Date
September 8 2017
End Date
October 25 2019
Last Update
September 4 2020
Active Locations (7)
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1
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan, 464-8681
2
Iizuka Hospital
Iizuka, Fukuoka, Japan, 820-8505
3
Kindai University Hospital, Department of Gastroenterology and Hepatology
Ōsaka-sayama, Osaka, Japan, 589-8511
4
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045