What side effects are associated with this type of intervention?

Common treatments for Hepatocellular Carcinoma (HCC) similar to those in the Tiragolumab trial include immunotherapies like Atezolizumab and targeted therapies like Bevacizumab. The known side effects of these treatments can include fatigue, diarrhea, hypertension, proteinuria, and increased risk of bleeding. Immunotherapies may also cause immune-related adverse events such as colitis, hepatitis, endocrinopathies, and pneumonitis. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Hepatocellular Carcinoma (HCC), particularly focusing on immune checkpoint inhibitors and monoclonal antibodies. Atezolizumab, an anti-PD-L1 antibody, in combination with Bevacizumab, an anti-VEGF antibody, has been approved for the treatment of unresectable or metastatic HCC. This combination has shown significant efficacy in improving overall survival and progression-free survival in patients. Other approved treatments include Sorafenib and Lenvatinib, which are tyrosine kinase inhibitors. These treatments align with the ongoing study of Tiragolumab, an anti-TIGIT monoclonal antibody, in combination with Atezolizumab and Bevacizumab, aiming to enhance the immune response against HCC.

What other types of research exist?

Promising novel alternatives to Tiragolumab for HCC patients include combinations of immune checkpoint inhibitors such as atezolizumab plus bevacizumab, and dual checkpoint inhibitors. The HIMALAYA trial results also suggest potential benefits from other immunotherapy-based combinations. These alternatives are expected to shape the treatment landscape in 2024.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to approximately 36 months

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

~2330

Bevacizumab

2013

Completed Phase 4

~5540

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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.