A Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma

NCT04829383 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BTCRC-GI20-457
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief Summary

This will be a nonrandomized, single arm feasibility study with the primary goal of evaluating the safety profile of the combination of atezolizumab and bevacizumab in patients with advanced/metastatic HCC with Child-Pugh B7 and B8 liver disease who have received no prior systemic therapy.

Conditions

Unresectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of toxicities

  Grade 3-5 treatment-related adverse event rate according to CTCAE v5

  1 year

Secondary Outcomes (5)

• Overall response rate (ORR)

  1 year

• Disease control rate (DCR)

  1 year

• Duration of response (DOR)

  1 year

• Median progression-free survival (PFS)

  1 year

• Median overall survival (OS)

  1 year

Study Arms (1)

Study Treatment

EXPERIMENTAL

Atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.

Drug: Atezolizumab; Drug: Bevacizumab

Interventions

Atezolizumab DRUG

1,200 mg

Also known as: Tecentriq

Study Treatment

Bevacizumab DRUG

15 mg/kg

Also known as: Avastin

Study Treatment

Eligibility Criteria

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

You may qualify if:

• Written informed consent and HIPAA authorization for release of personal health information must be obtained either from the subject or their representative. See protocol. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Age ≥ 18 years at the time of consent.
• ECOG Performance Status of 0-1.
• Locally advanced, metastatic, or unresectable hepatocellular carcinoma that has not received prior systemic therapy. Note: if no prior histologic diagnosis exists, prefer fresh biopsy if it is both safe and feasible. If fresh biopsy is not safe and feasible, imaging criteria may be used for diagnosis as per AASLD criteria in cirrhotic patients (please see www.aasld.org for up to date guidelines).
• Child Pugh Class B7 or B8 liver dysfunction or cirrhosis with the following limitations:
• Bilirubin ≤ 3 mg/dL
• Albumin ≥ 2.8 g/dL
• INR ≤ 1.7

You may not qualify if:

• At least 1 untreated measurable lesion according to RECIST 1.1.
• Willingness to undergo fresh tumor biopsy at baseline if safe and feasible. Note: archival tissue may be used at baseline provided histologic diagnosis was made and sufficient tissue is available for NGS analysis.
• NGS analysis must be requested from archival tissue or fresh biopsy (if applicable) as per standard of care. Foundation One CDX is the preferred platform. Prior NGS sequencing results (including from another platform) will be accepted if NGS sequencing was previously obtained (please see protocol).
• Demonstrate adequate bone marrow and organ function as defined below:
• Hematologic
• Absolute neutrophil count (ANC) ≥ 1,000/mcL
• Lymphocyte count ≥ 0.5 x 10\^9/L (500uL)
• Hemoglobin ≥ 90 g/L (9 g/dL)
• Platelet count ≥ 70,000/mcL
• Renal
• Serum creatinine OR calculated\* serum creatinine clearance (GFR can be used in place of creatinine or creatinine clearance) ≤ 1.5 x ULN OR ≥ 30 mL/min for participants with creatinine levels \> 1.5 x institutional ULN \*calculate serum creatinine clearance using the standard Coccroft-Gault formula
• Urine protein: Urine dipstick for proteinuria \< 2+ within 7 days prior to start of study treatment \*Patients with with ≥ 2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection which must demonstrate \< 1g of protein in 24 hours.
• Hepatic
• AST (SGOT) and ALT (SGPT) ≤ 8 x ULN
• Alkaline phosphastase (ALP) ≤ 8 x ULN

Sponsors & Collaborators

• Howard S Hochster: lead
• Genentech, Inc.: collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (7)

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

Location

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

New York University Clinical Cancer Center

New York, New York, 10016, United States

Location

DHR Health Institute for Research and Development

Edinburg, Texas, 785329, United States

Location

Univeristy of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Interventions

atezolizumab; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Howard S Hochster, DO, MPH

  Rutgers Cancer Institute of New Jersey

  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: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: March 22, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)