The Study of Atezolizumab, Bevacizumab and Memantine in Patients With Hepatocellular Carcinoma (HCC) ((HCC))

October 2, 2025 updated by: Inova Health Care Services

An Open Label Phase II Study of Atezolizumab, Bevacizumab and Memantine in Patients With Hepatocellular Carcinoma

The purpose of this research is to see the effect of triplet therapy with atezolizumab, bevacizumab, and memantine in treatment of your hepatocellular carcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to investigate the impact of targeting the NMDA receptor pathway, by enrolling patients with hepatocellular carcinoma undergoing systemic therapy. The study will involve adding memantine to the standard treatment of atezolizumab and bevacizumab, administered in 21-day cycles over six months. Patients will complete quality of life surveys at each cycle to assess their well-being and cancer-related symptoms.

Study Type

Interventional

Enrollment (Estimated)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Fairfax, Virginia, United States, 22033
        • Recruiting
        • Inova Schar Cancer Institute - Fair Oaks
        • Contact:
        • Principal Investigator:
          • Arthur Winer, MD
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Health Care Service
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arthur Winer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 or older.
  2. Patients have newly diagnosed and previously untreated, histologically or radiologically confirmed hepatocellular carcinoma with at least one lesion that is measurable by RECIST 1.1 criteria. A prior HCC lesion that was treated surgically or by radiation is allowed as long as it was at least 2 years or more from the current HCC diagnosis.
  3. Patient's cancer must be deemed locally advanced and unresectable
  4. Patients must have a Childs-Pugh cirrhosis score of A5 or A6.
  5. Eastern Cooperative Oncology Group Performance Status of 0-1.

  6. Patients must have bone marrow and organ function as defined below:

    • Absolute Neutrophil Count ≥ 1,500/μL
    • Platelets ≥ 100,000/μL
    • Hemoglobin ≥ 90 g/L (9g/dL)
    • Total Bilirubin ≤ 3 x ULN
    • AST(SGOT)/ALT(SGPT)/Alkaline Phosphatase ≤ 3 x ULN Or ≤5x ULN if due to liver involvement by tumor
    • Creatinine ≤ 2.0 mg/dL
    • eGFR (using Cockcroft Gault equation) > 40ml/min
  7. Chemotherapy is harmful to the human fetus. For this reason, sexually active males and females with partners of childbearing potential must agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study.
  8. Patients must demonstrate the ability to understand and the willingness to sign a written informed consent document.
  9. Men and women, regardless of race, ethnic group, or sexual orientation are eligible for this study.
  10. Patient must be able to swallow oral medication.

Exclusion Criteria:

  1. Patients with Childs-Pugh B or C cirrhosis.
  2. Female patients who are pregnant or breast-feeding.
  3. Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.
  4. Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator unsuitable for the study. This would include any uncontrolled or untreated viral infection such as HIV, HBV, HCV etc.
  5. Subject is enrolled in a separate interventional clinical trial.
  6. Active tuberculosis.
  7. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
  8. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  9. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulation.
  10. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  11. Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry.
  12. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment.
  13. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

18. Active, untreated grade 2 or 3 varices. Patients with treated varices to the point that they are grade 1 or less will be allowed.

19. Patients already on memantine for any reason prior to enrollment will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Addition of Memantine to Atezolizumab and Bevacizumab (the current systemic standard of care)
The study intervention consists of the use of the triplet therapy (atezolizumab, bevacizumab, and memantine) given in 21-day cycles over six months.
Drug: Memantine Hydrochloride
Memantine (5mg) is an N-methyl-D-aspartate (NMDA) receptor antagonist given in 21-day cycles over six months in combination with Bevacizumab and Atezolizumab. Each week memantine will be escalated by 5mg as tolerated
Other Names:
  • Namenda
Drug: Bevacizumab
Bevacizumab (15mg/kg) is a vascular endothelial growth factor inhibitor given in 21-day cycles over six months in combination with Memantine and Atezolizumab.
Other Names:
  • Avastin
Drug: Atezolizumab
Atezolizumab (1200mg) is a programmed death-ligand 1 (PD-L1) blocking antibody given in 21-day cycles over six months in combination with Memantine and Bevacizumab
Other Names:
  • Tecentriq

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) of patients who are treated with the combination of atezolizumab, bevacizumab, and memantine.
Time Frame: Up to 2 years
The effectiveness of the combination therapy using Azozolizumab, Bevacizumab,and Memantine in relation to the Objective Response Rate (ORR), defined as the proportion of complete or partial responses to the treatment by the response evaluation criteria for solid tumors(RECIST) 1.1.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Investigators

  • Principal Investigator: Arthur Winer, MD, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

October 27, 2026

Study Completion (Estimated)

January 27, 2028

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

January 23, 2025

Study Record Updates

Last Update Posted (Estimated)

October 7, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INOVA-2023-74

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on Memantine Hydrochloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe