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

NCT03389126 | Completed Phase 2

• 1 other identifier: H-1708-040-876
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• response rate

  RECIST v1.1

  6 weeks

Study Arms (1)

Avelumab

EXPERIMENTAL

Avelumab 10 mg/kg every 2 wks until disease progression or unacceptable toxicity

Drug: Avelumab

Interventions

Avelumab DRUG

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

Also known as: Bavencio

Avelumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:
• i) 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.
• ii) 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.

You may not qualify if:

• 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.
• 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 "

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33139266 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

avelumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Kyung-Hun Lee, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 3, 2018
• Study Start: December 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)