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

NCT ID: NCT03289533

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-08
• Study Completion Date: 2019-10-25

Brief Summary

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

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental 1

Avelumab (MSB0010718C) in combination with axitinib (AG-013736)

Group Type: EXPERIMENTAL

Avelumab (MSB0010718C)

Intervention Type: DRUG

Patients will receive avelumab 10 mg/kg Q2W in combination with axitinib 5 mg BID.

Axitinib (AG-013736)

Intervention Type: DRUG

Patients will receive avelumab 10 mg/kg Q2W in combination with axitinib 5 mg BID.

Interventions

Avelumab (MSB0010718C)

Patients will receive avelumab 10 mg/kg Q2W in combination with axitinib 5 mg BID.

Intervention Type: DRUG

Axitinib (AG-013736)

Patients will receive avelumab 10 mg/kg Q2W in combination with axitinib 5 mg BID.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Iizuka Hospital

Iizuka, Fukuoka, Japan

Kindai University Hospital, Department of Gastroenterology and Hepatology

Ōsaka-sayama, Osaka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Kyorin University Hospital, Department of Medical Oncology

Mitaka-shi, Tokyo, Japan

Japanese Red Cross Musashino Hospital

Musashino, Tokyo, Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B9991024

To obtain contact information for a study center near you, click here.

Other Identifiers

B9991024

Identifier Type: -

Identifier Source: org_study_id