NCT06006286

A Study Evaluating Atezolizumab and Bevacizumab Plus ADI-PEG 20 in Patients With Locally Advanced / Metastatic Hepatocellular Carcinoma

A Pilot Study Evaluating Atezolizumab and Bevacizumab Plus ADI-PEG 20 in Patients With Locally Advanced / Metastatic Hepatocellular Carcinoma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn about the safety and tolerability of atezolizumab, bevacizumab, and ADI-PEG 20 when given in combination to patients with locally advanced or metastatic liver cancer

Detailed description

Primary Objectives: --To evaluate the safety and tolerability of treatment with atezolizumab and bevacizumab + ADI-PEG 20 in Patients with Locally Advanced/ Metastatic Hepatocellular Carcinoma. Secondary Objectives: --To assess the pathologic response rate including pathologic complete response (pCR) per RECIST and degree of necrosis (\>50% in tumor volume) with atezolizumab and bevacizumab + ADI-PEG 20 in treatment-naïve locally advanced or metastatic HCC. Exploratory Objectives: --To assess the immunological/biomarker changes (pre- vs. post-treatment) in tumor tissues and peripheral blood in response to atezolizumab and bevacizumab + ADI-PEG 20 in HCC therapy and explore any potential association between these biomarker measures and antitumor response.

Conditions

• Metastatic Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Atezolizumab	Given by IV (vein)
DRUG	Bevacizumab	Given by IV (vein)
DRUG	ADI-PEG 20	Given by Injection (inj)

Timeline

• Start date: 2023-08-08
• Primary completion: 2023-11-10
• Completion: 2023-11-10
• First posted: 2023-08-23
• Last updated: 2024-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study