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Atezolizumab

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment122
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05168163Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver CancerPHASE2 RECRUITING 122May 27, 2022Dec 31, 2026Sep 16, 202516 United States
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05168163studyFirstPostDate: changed