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Monoclonal Antibodies

Atezolizumab + Bevacizumab +/- Tiragolumab for Liver Cancer (SKYSCRAPER-14 Trial)

Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to approximately 36 months
Awards & highlights
Pivotal Trial

Summary

This trial is testing a combination of three drugs—tiragolumab, atezolizumab, and bevacizumab—to treat advanced liver cancer that cannot be removed by surgery. These drugs help the immune system fight cancer and cut off the tumor's blood supply. The goal is to see if this combination is safe and effective for these patients.

Who is the study for?
This trial is for adults with advanced liver cancer (HCC) who haven't had systemic treatment before. They should be in good enough health to participate, not have a history of certain lung or autoimmune diseases, and can't be pregnant or breastfeeding. Men and women must use contraception to prevent pregnancy during the trial.
What is being tested?
The study tests tiragolumab combined with atezolizumab and bevacizumab as a first-line treatment for liver cancer. Participants will either receive this combination or a placebo alongside standard treatments to compare effectiveness and safety.
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions, increased risk of infections, bleeding issues due to blood vessel growth inhibition by Bevacizumab, fatigue, and potential complications in patients with hepatitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to approximately 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to approximately 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from Baseline in GHS/QoL, Physical Functioning, and Role Functioning Assessed Using the EORTC QLQ-C30
Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer 30 (QLQ-C30) Subscales

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Atezolizumab + Bevacizumab + TiragolumabExperimental Treatment3 Interventions
Atezolizumab plus bevacizumab plus tiragolumab will be administered every 3 weeks (Q3W) until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Group II: Atezolizumab + Bevacizumab + PlaceboPlacebo Group3 Interventions
Atezolizumab, bevacizumab plus placebo will be administered every 3 weeks (Q3W) until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~5860
Tiragolumab
2019
Completed Phase 3
~1390
Bevacizumab
2013
Completed Phase 4
~5540

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Hepatocellular Carcinoma (HCC) include immune checkpoint inhibitors like Atezolizumab and anti-angiogenic agents like Bevacizumab. Atezolizumab works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells. Bevacizumab inhibits vascular endothelial growth factor (VEGF), reducing the blood supply to tumors and thereby inhibiting their growth. Tiragolumab, an anti-TIGIT monoclonal antibody, is being studied for its potential to enhance the immune response against cancer cells by blocking TIGIT, a protein that suppresses immune activity. These mechanisms are crucial for HCC patients as they offer targeted approaches to slow tumor progression and potentially improve survival rates.
Angiogenesis Inhibitors for the Treatment of Hepatocellular Carcinoma.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,453 Previous Clinical Trials
1,095,059 Total Patients Enrolled
7 Trials studying Hepatocellular Carcinoma
5,338 Patients Enrolled for Hepatocellular Carcinoma
Chugai PharmaceuticalIndustry Sponsor
97 Previous Clinical Trials
21,794 Total Patients Enrolled
1 Trials studying Hepatocellular Carcinoma
42 Patients Enrolled for Hepatocellular Carcinoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,223 Previous Clinical Trials
894,773 Total Patients Enrolled
4 Trials studying Hepatocellular Carcinoma
5,260 Patients Enrolled for Hepatocellular Carcinoma

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05904886 — Phase 3
Hepatocellular Carcinoma Research Study Groups: Atezolizumab + Bevacizumab + Tiragolumab, Atezolizumab + Bevacizumab + Placebo
Hepatocellular Carcinoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05904886 — Phase 3
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05904886 — Phase 3
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