Rilvegostomig + Bevacizumab for Liver Cancer
(ARTEMIDE-HCC01 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot use certain medications like high-dose aspirin, some blood thinners, or immunosuppressive treatments close to the start of the study. It's best to discuss your current medications with the trial team.
Is the combination of Rilvegostomig and Bevacizumab safe for humans?
Tremelimumab, which is similar to Rilvegostomig, has been studied for safety in various cancers. It can cause side effects like reduced appetite and diarrhea, and serious side effects occurred in about 32.6% of patients when combined with another drug. Safety in liver cancer specifically has been explored, but side effects can vary.12345
What makes the drug combination of Rilvegostomig, Bevacizumab, and Tremelimumab unique for liver cancer?
This drug combination is unique because it combines Rilvegostomig and Bevacizumab, which target blood vessel growth in tumors, with Tremelimumab, an immunotherapy that helps the immune system attack cancer cells. This multi-faceted approach may offer a novel way to treat liver cancer by both cutting off the tumor's blood supply and enhancing the body's immune response.24567
What data supports the effectiveness of the drug combination Rilvegostomig, Bevacizumab, and Tremelimumab for liver cancer?
Tremelimumab, when combined with another drug called durvalumab, has shown to improve survival in patients with advanced liver cancer compared to another treatment called sorafenib. Additionally, Bevacizumab, when used with atezolizumab, is approved for first-line treatment of unresectable liver cancer, indicating its potential effectiveness in similar combinations.24789
Are You a Good Fit for This Trial?
This trial is for adults with advanced liver cancer (HCC) who can't have surgery or local treatments. They should be in good physical condition, not previously treated with systemic therapy for HCC, and without certain other health issues like active infections or a history of other cancers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Lead-in
A single-arm safety lead-in period to evaluate the safety and tolerability of rilvegostomig in combination with bevacizumab and tremelimumab
Randomised Treatment
Participants receive either rilvegostomig in combination with bevacizumab with or without tremelimumab, or atezolizumab in combination with bevacizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Rilvegostomig
- Tremelimumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology