Recruiting
Phase 2

Atezolizumab, Bevacizumab, Memantine

Sponsor:

Inova Health Care Services

Code:

NCT06789757

Conditions

Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Memantine Hydrochloride

Bevacizumab

Atezolizumab

Study Details

Brief summary:

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

Conditions

Hepatocellular Carcinoma

Study ID

NCT06789757

Start date

Feb 25, 2025

Status verified date

Oct, 2025

Completion date

Jan 27, 2028

Anticipated

Primary completion date

Oct 27, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

19 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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

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.

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

Primary outcome measure

  • Objective response rate (ORR) of patients who are treated with the combination of atezolizumab, bevacizumab, and memantine. [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Locations

Inova Schar Cancer Institute - Fair Oaks

Recruiting

Fairfax, Virginia, United States, 22033

Contacts

Principal Investigator:

Arthur Winer, MD

Inova Health Care Service

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Principal Investigator:

Arthur Winer

More Information

Sponsor

Inova Health Care Services

Last update posted

Oct 7, 2025

Last verified

Oct, 2025

Keywords

  • Atezolizumab
  • Bevacizumab
  • Memantine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Inova Health Care Services on 2025-10-07.