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

Last updated on June 7, 2018

FOR MORE INFORMATION
Study Location
Aichi Cancer Center Hospital
Nagoya, Aichi, 464-8681 Japan
Contact
1-800-718-1021
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).

NCT03289533
Pfizer
Recruiting
A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100)

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A Study Of Avelumab In Combination With Axitinib In Advanced HCC
An Open Label, Single Arm Phase 1b Study Of Avelumab Plus Axitinib As First Line Treatment In Patients With Advanced Hepatocellular Carcinoma
To evaluate the safety, efficacy and PK of avelumab in combination with axitinib as first line treatment in patients with advanced HCC
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Hepatocellular
  • 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.
Experimental: Experimental 1
Avelumab (MSB0010718C) in combination with axitinib (AG-013736)
Interventions:
  • Drug: Avelumab (MSB0010718C)
  • Drug: Axitinib (AG-013736)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
January 6, 2020
September 30, 2019   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Japan
 
 
NCT03289533
B9991024
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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