Atezolizumab + Bevacizumab +/− SRF388 for Liver Cancer
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
Randomized Phase
Approximately 104 patients will be randomized to receive either SRF388 with atezolizumab plus bevacizumab or placebo with atezolizumab plus bevacizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Atezolizumab
- Bevacizumab
- Placebo
- SRF388
Atezolizumab is already approved in United States, European Union for the following indications:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
- 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
Surface Oncology
Lead Sponsor