Study Details

Open

Ph3 Randomized, Double-blinded, Placebo with Atezolizumab and Bevacizumab

This study is assessing the effectiveness and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when given with atezolizumab and bevacizumab as a first-line treatment for unresectable, locally advanced or metastatic patients with hepatocellular carcinoma (HCC). TIGIT is thought to play an important role in HCC's response to immunotherapy treatments such as atezolizumab. This study will assess whether the addition of tiragolumab to atezolizumab and bevacizumab will improve response and clinical outcomes.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Extended hours (M-F, early morning or evening)
Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

There are often multiple options presented to patients after being diagnosed with hepatocellular carcinoma. This study is designed to test the additoin of an investigational drug (An investigational drug is one that has not been approved by the regulatory authorities in your country) to the standard of care treatment to see if it improves the treatment of hepatocellular carcinoma. This study has two cohorts/options, and you will be placed in one of the following treatment groups: • Arm A: You will receive atezolizumab plus bevacizumab plus tiragolumab given as an infusion (into the vein) every three weeks. • Arm B: You will receive atezolizumab plus bevacizumab plus placebo given as an infusion (into the vein) every three weeks. Your group will be decided by chance (like tossing a coin). You will have an equal chance of being placed in any group.

In-person visits:
12

Total length of participation:
36 months

Looking for Specific Volunteers

Able to participate:

Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by AASLD criteria in cirrhotic participants
Disease that is not amenable to curative surgical and/or locoregional therapies
Measurable disease (at least one untreated target lesion) according to RECIST v1.1
No prior systemic treatment (including systemic investigational agents) for locally advanced or metastatic and/or unresectable HCC

Not eligible if:

Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory
History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Jingquan Jia
Medicine- Oncology

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Kidney)

IRB Number

23-1402

ClinicalTrials.gov

NCT05904886