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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06006286
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Metastatic Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Given by IV (vein)
  • Bevacizumab — DRUG
    Given by IV (vein)
  • ADI-PEG 20 — DRUG
    Given by Injection (inj)

Study Details

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

Key Dates

Start date
Aug 8, 2023
Status verified
Aug 2024
Primary completion
Nov 10, 2023
Completion
Nov 10, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ADI-PEG20/ATEZO/BEV
    Participants will first receive the study drug combination for up to 12 weeks. If participants have stable disease or a partial response to the study drug after 12 weeks, participants may continue to receive ADI-PEG 20 for up to 2 years of total dosing, and participants may continue to receive atezolizumab and bevacizumab indefinitely (no limit)

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TX

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