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Carcinoma, HepatocellularPhase 2AvelumabHCCNCT03389126

Phase II Study of Avelumab in Patients With Advanced Hepatocellular Carcinoma After Prior Sorafenib Treatment

A Phase 2 study testing Avelumab in people with Carcinoma, Hepatocellular, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An open label, single arm, Phase II study of avelumab in patients with advanced hepatocellular carcinoma after prior sorafenib treatment Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Avelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
1 Dec 2017to 31 Jan 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to understand the purpose of the study, provide signed and dated informed consent, and able to comply with all procedures
  • Male or female subjects aged ≥ 18 years
  • Histologically or cytologically proven advanced hepatocellular carcinoma not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies.
  • Patients who were intolerant to sorafenib or for whom sorafenib failed.
  • At least one RECIST 1.1 measurable untreated lesion. All subjects must have at least one previously untreated, unidimensionally measurable lesion by contrast-enhanced spiral computed tomography (CT) ≥ 10 mm or contrast enhanced dynamic magnetic resonance imaging (MRI) scan ≥ 10 mm (malignant lymph nodes must be ≥ 15 mm on short axis)
  • ECOG performance status of 0 to 1 at trial entry
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  • Child-Pugh Class A
  • Subjects are eligible to enroll if they have non-viral-HCC, or if they have HBV-HCC, or HCV-HCC defined as follows:
  • HBV-HCC: Resolved HBV infection (as evidenced by detectable HBV surface antibody, detectable HBV core antibody, undetectable HBV DNA, and undetectable HBV surface antigen) or Chronic HBV infection (as evidenced by detectable HBV surface antigen or HBV DNA). Subjects with chronic HBV infection must have HBV DNA < 100 IU/mL and must be on antiviral therapy.
  • HCV-HCC: Active or resolved HCV infection as evidenced by detectable HCV RNA or antibody
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test. Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last avelumab treatment administration if the risk of conception exists.
  • Males who are sexually active with WOCBP must agree to follow instructions for method of contraception as indicated in the informed consent form, for the duration of treatment with study drug plus 5 half-lives of the study drug plus 90 days.

Who cannot join

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Prior liver transplant
  • Active, known, or suspected autoimmune disease
  • Pregnancy or lactation period
  • Participation in another clinical trial within the past 30 days
  • Inadequate hepatic function defined by a total bilirubin level > 3.0 mg/dl, an AST level > 5 × the upper limit of normal range (ULN), and an ALT level > 5 × ULN.
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  • Inadequate renal function defined by an estimated creatinine clearance < 50 mL/min according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24 hour urine collection
  • Inadequate hematologic function defined by WBC < 2000/μL, Platelets < 60,000/μL, Hemoglobin < 8.5 g/dL.
  • Active brain metastases or leptomeningeal metastases, requiring immunosuppressive doses of corticosteroids (> 10 mg/day prednisone equivalents).
  • IMMUNOSUPRESSANTS: "Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)."
  • AUTOIMMUNE DISEASE: "Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible."
  • ORGAN TRANSPLANTATION: "Prior organ transplantation including allogenic stem-cell transplantation."
  • INFECTIONS: "Active infection requiring systemic therapy. "
  • HIV/AIDS: "Known history of testing positive for HIV or known acquired immunodeficiency syndrome."
  • VACCINATION: "Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines "
  • HYPERSENSITIIVTY TO STUDY DRUG: "Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3)"
  • CARDIOVASCULAR DISEASE: "Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication."
  • OTHER PERSISTING TOXICITIES: "Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable."
  • Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • Any history of clinically meaningful variceal bleeding within the last three months 21, Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies (or other agents specifically targeting immune checkpoint pathway)
  • 22. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

An open label, single arm, Phase II study of avelumab in patients with advanced hepatocellular carcinoma after prior sorafenib treatment

Read the detailed description

This is an open label study of avelumab monotherapy. Patients with advanced hepatocellular carcinoma after prior sorafenib treatment are eligible. Patients should have failed to sorafenib or be intolerant to sorafenib.

Being tested
Avelumab
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AvelumabDrug

    Also called Bavencio

    Avelumab 10 mg/kg intravenous injection every 2 weeks until disease progression or unacceptable toxicity

Study groups in NCT03389126
Study groupRoleWhat they receive
AvelumabExperimentalAvelumab 10 mg/kg every 2 wks until disease progression or unacceptable toxicity
Receives: Drug: Avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. response rate

    RECIST v1.1

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2018
  2. Study start1 Dec 2017
  3. Primary completion31 Dec 2019
  4. Study completion31 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03389126
Sponsor's protocol ID
H-1708-040-876
Acronym
AvelumabHCC
Status last verified
Mar 2021
First submitted
27 Dec 2017
Last updated
17 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data sharing should be decided upon formal documented requests.

Publications

  • Lee DW, Cho EJ, Lee JH, Yu SJ, Kim YJ, Yoon JH, Kim TY, Han SW, Oh DY, Im SA, Kim TY, Lee Y, Kim H, Lee KH. Phase II Study of Avelumab in Patients with Advanced Hepatocellular Carcinoma Previously Treated with Sorafenib. Clin Cancer Res. 2021 Feb 1;27(3):713-718. doi: 10.1158/1078-0432.CCR-20-3094. Epub 2020 Nov 2.

    PubMed 33139266

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avelumab in people with Carcinoma, Hepatocellular, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

response rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03389126, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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