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
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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.
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2025-02-27
Status change Recruiting→Active, Not Recruitingv22
2023-08-10
Status change Not Yet Recruiting→Recruitingv2
| 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 |