Atezolizumab + Bevacizumab +/- Tiragolumab for Liver Cancer

(SKYSCRAPER-14 Trial)

Recruiting in Palo Alto (17 mi)

+247 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot have had prior systemic treatment for liver cancer or be on systemic immunosuppressive or immunostimulatory medications.

What data supports the idea that Atezolizumab + Bevacizumab +/- Tiragolumab for Liver Cancer is an effective drug?

The available research shows that the combination of atezolizumab and bevacizumab is more effective than sorafenib, an older treatment, for liver cancer that cannot be removed by surgery. This combination has become the standard first choice for treating advanced liver cancer. Studies have shown that it helps patients live longer and is considered safe for older patients as well. It was approved in 2020 as a first-line treatment, meaning it's the first option doctors consider for advanced liver cancer. ^{1 2 3 4 5}

What safety data is available for the treatment of atezolizumab plus bevacizumab for liver cancer?

The combination of atezolizumab and bevacizumab has been approved by the FDA for the treatment of advanced hepatocellular carcinoma (HCC) based on the IMbrave150 study. Common adverse reactions in more than 20% of patients include hypertension, fatigue/asthenia, and proteinuria. Hemorrhage was reported in 25% of patients. The treatment has shown improved overall survival and progression-free survival compared to sorafenib, a standard treatment. Safety evaluations, including checking for varices, are recommended before starting treatment. Additional studies have confirmed the safety and efficacy of this combination in various patient populations, including older adults and those with viral infections. ^{4 6 7 8 9}

Is the drug Atezolizumab, Bevacizumab, Tiragolumab promising for liver cancer?

Yes, the combination of Atezolizumab and Bevacizumab is considered a promising treatment for advanced liver cancer. It has been approved as a first-line treatment and is seen as a breakthrough that improves survival rates compared to previous treatments. ^{1 4 5 10 11}

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

Inclusion Criteria

My liver function is classified as Child-Pugh Class A.

I will use protection or abstain from sex to prevent pregnancy during and after treatment.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

Pregnancy or breastfeeding within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo

I had bleeding from esophageal or stomach varices in the last 6 months.

Treatment with investigational therapy within 28 days prior to initiation of study treatment

Treatment Details

Interventions

• Atezolizumab (Monoclonal Antibodies)
• Bevacizumab (Monoclonal Antibodies)
• Tiragolumab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Atezolizumab + Bevacizumab + Tiragolumab Experimental Treatment 3 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 + Placebo Placebo Group 3 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.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

🇪🇺 Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Kaiser Permanente; Oncology Clinical Trials Vallejo, CA

Kelsey Seybold Clnic Houston, TX

Genesis Cancer Center Hot Springs, AR

UCLA MEDICAL CENTER; Alhambra Alhambra, CA

More Trial Locations

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2482

Patients Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Chugai Pharmaceutical

Industry Sponsor

Trials

105

Patients Recruited

25,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of atezolizumab plus bevacizumab treatment for advanced hepatocellular carcinoma in the real world: a single-arm meta-analysis. Gao, X., Zhao, R., Ma, H., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Data for Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma: How Does Adherence to the IMbrave150 Trial Inclusion Criteria Impact Prognosis? Rimini, M., Persano, M., Tada, T., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential feasibility of atezolizumab-bevacizumab therapy in patients with hepatocellular carcinoma treated with tyrosine-kinase inhibitors. Stefanini, B., Bucci, L., Santi, V., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of older age in patients receiving atezolizumab and bevacizumab for hepatocellular carcinoma. Vithayathil, M., D'Alessio, A., Fulgenzi, CAM., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab plus Bevacizumab: A Novel Breakthrough in Hepatocellular Carcinoma. Castet, F., Willoughby, CE., Haber, PK., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma. Casak, SJ., Donoghue, M., Fashoyin-Aje, L., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma. Cheon, J., Yoo, C., Hong, JY., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatic Events and Viral Kinetics in Hepatocellular Carcinoma Patients Treated with Atezolizumab plus Bevacizumab. Hsu, C., Ducreux, M., Zhu, AX., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events as potential predictive factors of therapeutic activity in patients with unresectable hepatocellular carcinoma treated with atezolizumab plus bevacizumab. Tada, T., Kumada, T., Hiraoka, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Role of Atezolizumab Plus Bevacizumab Therapy in the Sequential Treatment of Unresectable Hepatocellular Carcinoma. Komatsu, S., Yano, Y., Fujishima, Y., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperprogressive disease in patients with unresectable hepatocellular carcinoma receiving atezolizumab plus bevacizumab therapy. Maesaka, K., Sakamori, R., Yamada, R., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of atezolizumab plus bevacizumab treatment for advanced hepatocellular carcinoma in the real world: a single-arm meta-analysis. [2023]

2. France pubmed.ncbi.nlm.nih.gov

Real-World Data for Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma: How Does Adherence to the IMbrave150 Trial Inclusion Criteria Impact Prognosis? [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Potential feasibility of atezolizumab-bevacizumab therapy in patients with hepatocellular carcinoma treated with tyrosine-kinase inhibitors. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of older age in patients receiving atezolizumab and bevacizumab for hepatocellular carcinoma. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Atezolizumab plus Bevacizumab: A Novel Breakthrough in Hepatocellular Carcinoma. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Hepatic Events and Viral Kinetics in Hepatocellular Carcinoma Patients Treated with Atezolizumab plus Bevacizumab. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse events as potential predictive factors of therapeutic activity in patients with unresectable hepatocellular carcinoma treated with atezolizumab plus bevacizumab. [2023]

10. Greece pubmed.ncbi.nlm.nih.gov

Current Role of Atezolizumab Plus Bevacizumab Therapy in the Sequential Treatment of Unresectable Hepatocellular Carcinoma. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Hyperprogressive disease in patients with unresectable hepatocellular carcinoma receiving atezolizumab plus bevacizumab therapy. [2022]