50 Participants Needed

Atezolizumab + Bevacizumab for Liver Cancer

(AB7 Trial)

Recruiting at 6 trial locations
JB
KS
LH
LH
KW
HS
JS
GT
Overseen ByGabrielle Tiggs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive medications, you must stop them 6 weeks before starting the trial, unless they are low-dose corticosteroids or certain other exceptions.

What data supports the effectiveness of the drug combination Atezolizumab and Bevacizumab for liver cancer?

Research shows that the combination of atezolizumab and bevacizumab improves overall survival in patients with advanced liver cancer compared to the previous standard treatment, sorafenib. This combination is now considered the gold standard for first-line treatment of advanced liver cancer.12345

Is the combination of Atezolizumab and Bevacizumab safe for treating liver cancer?

The combination of Atezolizumab and Bevacizumab has been studied for liver cancer and is generally considered safe, but it can cause side effects like high blood pressure, tiredness, and protein in the urine. Bleeding was more common in patients taking this combination compared to another treatment, so monitoring is recommended.26789

How is the drug combination of atezolizumab and bevacizumab unique for liver cancer treatment?

The combination of atezolizumab and bevacizumab is unique because it is the new standard first-line treatment for advanced liver cancer, offering improved survival compared to previous options like sorafenib. This combination therapy represents a significant advancement in managing liver cancer across various stages.1251011

What is the purpose of this trial?

This will be a nonrandomized, single arm feasibility study with the primary goal of evaluating the safety profile of the combination of atezolizumab and bevacizumab in patients with advanced/metastatic HCC with Child-Pugh B7 and B8 liver disease who have received no prior systemic therapy.

Research Team

Howard S. Hochster, MD, FACP | Rutgers ...

Howard S. Hochster

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

This trial is for adults with advanced liver cancer (Hepatocellular Carcinoma) who haven't had systemic therapy before. They should have a specific level of liver dysfunction (Child-Pugh B7 or B8), be able to perform daily activities with little help, and agree to use contraception. People can't join if they're on high-dose steroids, have certain heart or lung conditions, uncontrolled other diseases, or are expected to need treatment for another cancer within two years.

Inclusion Criteria

I have at least one cancer spot that hasn't been treated yet.
Written informed consent and HIPAA authorization for release of personal health information
As determined by the enrolling physician or protocol designee, ability of the subject to understand a written informed consent document, and ability and willingness to comply with study procedures
See 8 more

Exclusion Criteria

I have significant fluid buildup in my abdomen.
I do not have another cancer that needs treatment within 2 years.
I have had radiation for any painful cancer spots before joining.
See 23 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity

Up to 1 year
Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

  • Atezolizumab
  • Bevacizumab
Trial Overview The study tests the safety of combining Atezolizumab and Bevacizumab in patients with advanced liver cancer. It's a single group trial where all participants receive both drugs without being compared to another treatment or placebo.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Study TreatmentExperimental Treatment2 Interventions
Atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.

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

Who Is Running the Clinical Trial?

Kristen Spencer

Lead Sponsor

Trials
2
Recruited
130+

Howard S. Hochester

Lead Sponsor

Trials
1
Recruited
50+

Howard S Hochster

Lead Sponsor

Trials
1
Recruited
50+

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Rutgers Cancer Institute of New Jersey

Collaborator

Trials
72
Recruited
22,200+

Findings from Research

The combination of atezolizumab and bevacizumab has been shown to significantly increase overall survival in patients with advanced hepatocellular carcinoma (HCC) compared to sorafenib.
The FDA's approval of this combination therapy marks a significant advancement in the treatment of HCC, potentially changing how the disease is managed across all stages.
Atezolizumab plus Bevacizumab: A Novel Breakthrough in Hepatocellular Carcinoma.Castet, F., Willoughby, CE., Haber, PK., et al.[2022]
In a study of 191 patients with unresectable hepatocellular carcinoma (HCC), the combination therapy of atezolizumab and bevacizumab showed similar overall survival and progression-free survival rates in older patients (≥65 years) compared to younger patients (<65 years), indicating its efficacy across age groups.
The safety profile of the combination therapy was comparable between older and younger patients, with similar rates of treatment-related adverse events, including severe adverse events, suggesting that older patients can tolerate this treatment as well as younger patients.
Impact of older age in patients receiving atezolizumab and bevacizumab for hepatocellular carcinoma.Vithayathil, M., D'Alessio, A., Fulgenzi, CAM., et al.[2023]
The combination of atezolizumab and bevacizumab has recently become the new standard of care for patients with advanced hepatocellular carcinoma (HCC), replacing sorafenib, which was the standard for over a decade.
This review highlights practical aspects of using the atezolizumab and bevacizumab combination, including evidence for its efficacy, indications for use, management of side effects, and areas needing further research, making it a valuable resource for clinicians.
Atezolizumab and bevacizumab as first line therapy in advanced hepatocellular carcinoma: Practical considerations in routine clinical practice.Jain, A., Chitturi, S., Peters, G., et al.[2021]

References

Atezolizumab plus Bevacizumab: A Novel Breakthrough in Hepatocellular Carcinoma. [2022]
Impact of older age in patients receiving atezolizumab and bevacizumab for hepatocellular carcinoma. [2023]
Atezolizumab and bevacizumab as first line therapy in advanced hepatocellular carcinoma: Practical considerations in routine clinical practice. [2021]
Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): a randomised, open-label, multicentre, phase 3 trial. [2023]
Efficacy and safety of atezolizumab plus bevacizumab treatment for advanced hepatocellular carcinoma in the real world: a single-arm meta-analysis. [2023]
FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma. [2022]
Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma. [2022]
Adverse events as potential predictive factors of therapeutic activity in patients with unresectable hepatocellular carcinoma treated with atezolizumab plus bevacizumab. [2023]
Initial Experience of Atezolizumab Plus Bevacizumab for Unresectable Hepatocellular Carcinoma in Real-World Clinical Practice. [2021]
Current Role of Atezolizumab Plus Bevacizumab Therapy in the Sequential Treatment of Unresectable Hepatocellular Carcinoma. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Safety and efficacy of atezolizumab plus bevacizumab in elderly patients with hepatocellular carcinoma: A multicenter analysis. [2022]
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