134 Participants Needed

Atezolizumab + Bevacizumab +/− SRF388 for Liver Cancer

Recruiting at 34 trial locations
BB
HO
Overseen ByHillary O'Kelly, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Coherus Biosciences, Inc.
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

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

The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic steroid therapy or systemic immunosuppressive medications, you may not be eligible to participate.

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

The combination of Atezolizumab and Bevacizumab has been shown to improve overall survival and progression-free survival in patients with advanced liver cancer compared to the standard treatment with sorafenib. This combination is now considered a new standard of care for this condition.12345

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

The combination of Atezolizumab and Bevacizumab has been shown to be generally safe for liver cancer patients, with common side effects including high blood pressure, fatigue, and protein in the urine. However, there is a higher risk of bleeding, and serious side effects occurred in some patients, including a few deaths.24678

What makes the drug combination of Atezolizumab, Bevacizumab, and SRF388 unique for liver cancer?

This drug combination is unique because it includes Atezolizumab and Bevacizumab, which are already approved as a first-line treatment for advanced liver cancer, and adds SRF388, potentially enhancing the treatment's effectiveness. Atezolizumab helps the immune system attack cancer cells, while Bevacizumab inhibits blood vessel growth that tumors need to grow, and SRF388 may offer additional benefits, although its specific role in this combination is still being studied.345910

What is the purpose of this trial?

This trial tests SRF388 with atezolizumab and bevacizumab in patients with advanced liver cancer. The treatment aims to enhance immune response and block blood supply to tumors. Atezolizumab and bevacizumab have become the standard of care for advanced hepatocellular carcinoma, replacing sorafenib which was the standard for over ten years.

Research Team

KI

Koho Iizuka, MD

Principal Investigator

Coherus Biosciences, Inc.

Eligibility Criteria

Adults with advanced liver cancer (Hepatocellular Carcinoma) who haven't had systemic treatment for their condition can join this trial. They should be in relatively good health, able to perform daily activities with ease or slight difficulty, and have a liver that's still working well. Pregnant women can't participate, and those who can have children must use birth control.

Inclusion Criteria

My liver disease is mild.
I haven't had any treatments for my advanced liver cancer.
Laboratory values indicative of adequate organ function as defined in the protocol
See 6 more

Exclusion Criteria

I frequently need procedures to remove excess fluid from my body.
I am on or might need strong medication to suppress my immune system.
I have an autoimmune disease or immune deficiency, but it's controlled or minor.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lead-In

A minimum of 6 patients and up to 30 patients will be enrolled in an open-label Lead-In to assess the preliminary safety and tolerability of SRF388 with atezolizumab plus bevacizumab

Not specified
Open-label treatment

Randomized Phase

Approximately 104 patients will be randomized to receive either SRF388 with atezolizumab plus bevacizumab or placebo with atezolizumab plus bevacizumab

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

  • Atezolizumab
  • Bevacizumab
  • Placebo
  • SRF388
Trial Overview The study is testing the effectiveness of SRF388 combined with Atezolizumab and Bevacizumab versus a placebo mixed with the same two drugs in treating first-line advanced liver cancer. Participants are randomly assigned to one of these groups to compare results.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Lead-InExperimental Treatment3 Interventions
A minimum of 6 patients and up to 30 patients will be enrolled in an open-label Lead-In to assess the preliminary safety and tolerability of SRF388 with atezolizumab plus bevacizumab.
Group II: Arm B: Placebo in combination with atezolizumab plus bevacizumabExperimental Treatment3 Interventions
Patients randomized to Arm B will receive placebo with atezolizumab plus bevacizumab.
Group III: Arm A: SRF388 in Combination with atezolizumab plus bevacizumabExperimental Treatment3 Interventions
Patients randomized to Arm A will receive SRF388 with atezolizumab plus bevacizumab.

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?

Coherus Biosciences, Inc.

Lead Sponsor

Trials
19
Recruited
3,700+

Surface Oncology

Lead Sponsor

Trials
6
Recruited
730+

Findings from Research

The combination of atezolizumab and bevacizumab (AB) has been established as the preferred treatment for hepatocellular carcinoma (HCC) patients at Barcelona Liver Cancer Clinic stage C, showing better outcomes than sorafenib.
Despite its effectiveness, many patients do not experience significant survival benefits or responses, highlighting the urgent need for predictive biomarkers to guide treatment decisions for those receiving AB.
Predicting Outcomes of Atezolizumab and Bevacizumab Treatment in Patients with Hepatocellular Carcinoma.Han, JW., Jang, JW.[2023]
Atezolizumab in combination with bevacizumab has been approved by the FDA for treating unresectable hepatocellular carcinoma (HCC), showing improved overall survival (OS) and progression-free survival (PFS) compared to sorafenib, with a hazard ratio of 0.58 for OS.
The combination therapy resulted in a median PFS of 6.8 months versus 4.3 months for sorafenib, although it was associated with a higher incidence of hemorrhage (25% vs. 17%), highlighting the need for careful monitoring of patients.
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]
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]

References

Predicting Outcomes of Atezolizumab and Bevacizumab Treatment in Patients with Hepatocellular Carcinoma. [2023]
FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma. [2022]
Atezolizumab plus Bevacizumab: A Novel Breakthrough in Hepatocellular Carcinoma. [2022]
Real-World Data for Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma: How Does Adherence to the IMbrave150 Trial Inclusion Criteria Impact Prognosis? [2023]
Efficacy and safety of atezolizumab plus bevacizumab treatment for advanced hepatocellular carcinoma in the real world: a single-arm meta-analysis. [2023]
Atezolizumab Plus Bevacizumab in Patients with Advanced and Progressing Hepatocellular Carcinoma: Retrospective Multicenter Experience. [2023]
Safety and efficacy of atezolizumab plus bevacizumab in elderly patients with hepatocellular carcinoma: A multicenter analysis. [2022]
Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma. [2022]
Current Role of Atezolizumab Plus Bevacizumab Therapy in the Sequential Treatment of Unresectable Hepatocellular Carcinoma. [2022]
IMbrave150: Efficacy and Safety of Atezolizumab plus Bevacizumab versus Sorafenib in Patients with Barcelona Clinic Liver Cancer Stage B Unresectable Hepatocellular Carcinoma: An Exploratory Analysis of the Phase III Study. [2023]
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