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Atezolizumab

Phase 2

Locally Advanced Hepatocellular Carcinoma | Monoclonal antibody | Oncology |United Therapeutics Corporation|Last Updated: Sep 16, 2025

Target and mechanism

Molecular targetCD274
Target classInhibitor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment122

FDA Designations

No designations recorded

Clinical trial landscape

Atezolizumab · 1 trial · 9 indications

Phase 2 1
NCT05168163Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver CancerLocally Advanced Hepatocellular Carcinoma
RECRUITING122 Analytics
PHASE2RECRUITING
Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer
Locally Advanced Hepatocellular CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall survival (OS)
From randomization to death from any cause, assessed up to 3 years

The final analysis for OS will be conducted when 84 OS events are observed, approximately 36 months after first subject in and will be evaluated with a one-sided p-value from stratified log-rank test.

Progression-free survival (PFS)
From randomization to first documentation of disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) or death, assessed up to 2 years

PFS analysis will be conducted when 89 PFS events are observed. The one-sided p-value from stratified log-rank test will be used for decision making.

Secondary Endpoints

Objective response rate (ORR)
Up to 2 years
Duration of response
Up to 2 years
Incidence of adverse events (AEs)
Up to 30 days after last dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A (atezolizumab, cabozantinib or lenvatinib)EXPERIMENTALPatients receive atezolizumab IV over 30-60 minutes on day 1 and cabozantinib PO QD or lenvatinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm B (cabozantinib or lenvatinib)ACTIVE_COMPARATORPatients receive cabozantinib PO QD or lenvatinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Interventions

NameTypeDescription
AtezolizumabBIOLOGICALGiven IV
CabozantinibDRUGGiven PO
LenvatinibDRUGGiven PO
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Provide written informed consent =\< 28 days prior to randomization * Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) * NOTE: During the Active Monitoring Phase of a study (i.e., active treatment and clinical follow...

Countries:United States
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Frequently asked questions about Atezolizumab

What is Atezolizumab used for in hepatocellular carcinoma?

Atezolizumab is being studied for the treatment of unresectable, locally advanced, or metastatic liver cancer, specifically hepatocellular carcinoma. It is being evaluated in combination with a multi-kinase inhibitor in a Phase 2 clinical trial enrolling 122 patients in the United States.

What does Atezolizumab target?

Atezolizumab is a monoclonal antibody, classified as a -mab antibody. It is being studied in combination with a multi-kinase inhibitor for the treatment of unresectable, locally advanced, or metastatic liver cancer. The trial is actively recruiting patients.

Who is developing Atezolizumab for hepatocellular carcinoma?

United Therapeutics Corporation (UTHR) is developing Atezolizumab for the treatment of unresectable, locally advanced, or metastatic liver cancer. The company is conducting a Phase 2 clinical trial in the United States with a planned enrollment of 122 patients.

What phase is Atezolizumab in for hepatocellular carcinoma?

Atezolizumab is in Phase 2 clinical development for the treatment of unresectable, locally advanced, or metastatic liver cancer. The trial is actively recruiting participants and is randomized and active-controlled, though it is not double-blinded.

What clinical trials is Atezolizumab in for hepatocellular carcinoma?

Atezolizumab is being studied in clinical trial NCT05168163, titled "Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer." This Phase 2 trial is recruiting 122 patients in the United States.

Is Atezolizumab being studied with a biomarker in hepatocellular carcinoma?

Yes, the Phase 2 clinical trial of Atezolizumab for unresectable, locally advanced, or metastatic liver cancer is biomarker-selected. The trial is active-controlled and randomized, enrolling patients aged 18 years and older in the United States.