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

NCT03289533

Last updated date
Study Location
Aichi Cancer Center Hospital
Nagoya, Aichi, 464-8681, Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatocellular Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100)
Official Title  ICMJE AN OPEN LABEL, SINGLE ARM PHASE 1B STUDY OF AVELUMAB PLUS AXITINIB AS FIRST LINE TREATMENT IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA
Brief Summary To evaluate the safety, efficacy and PK of avelumab in combination with axitinib as first line treatment in patients with advanced HCC
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Hepatocellular
Intervention  ICMJE
  • Drug: Avelumab (MSB0010718C)
    Patients will receive avelumab 10 mg/kg Q2W in combination with axitinib 5 mg BID.
  • Drug: Axitinib (AG-013736)
    Patients will receive avelumab 10 mg/kg Q2W in combination with axitinib 5 mg BID.
Study Arms  ICMJE Experimental: Experimental 1
Avelumab (MSB0010718C) in combination with axitinib (AG-013736)
Interventions:
  • Drug: Avelumab (MSB0010718C)
  • Drug: Axitinib (AG-013736)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2019)
22
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2017)
20
Actual Study Completion Date  ICMJE October 25, 2019
Actual Primary Completion Date August 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of locally advanced or metastatic HCC, obtained by histology/cytology (on a prior tumor biopsy) or by imaging with serum ?-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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03289533
Other Study ID Numbers  ICMJE B9991024
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP