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NCT05904886 · ClinicalTrials.gov record · last posted 2025-12-31

A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) (IMbrave152)

Study acronym: SKYSCRAPER-14
StatusActive, Not Recruiting
PhasePhase 3
Started2023-09-14
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic HCC. Per amendment version 5, following a memo issued by the Sponsor, participants receiving treatment in the atezolizumab plus bevacizumab plus tiragolumab arm are recommended to discontinue tiragolumab treatment unless the investigator decides the benefit outweighs the risk. Participants receiving treatment in atezolizumab plus bevacizumab plus placebo arm must discontinue placebo treatment. Participants may continue receiving active treatment(s) per protocol until loss of clinical benefit or unacceptable toxicity, whichever occurs first.

Amendment record 29 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 29 times since 2023-06-14; most recent amendment 2026-06-19. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-02-27
Status change RecruitingActive, Not Recruitingv22
2023-08-10
Status change Not Yet RecruitingRecruitingv2
Trial Details
NCT Number NCT05904886
Lead Sponsor Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical
Conditions Hepatocellular Carcinoma
Enrollment 687 participants
Start Date 2023-09-14
Primary Completion 2025-05-08 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-31