Rilvegostomig + Bevacizumab for Liver Cancer

(ARTEMIDE-HCC01 Trial)

Recruiting at 45 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

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

Eligibility Criteria

Inclusion Criteria

At least one measurable target lesion

I am fully active or can carry out light work.

I do not have both HBV and HCV infections.

Exclusion Criteria

I haven't had radiotherapy (except for bone lesions) recently.

I have been treated with anti-CTLA-4 or anti-TIGIT before.

I have cancer that has spread to my brain or spinal cord.

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• Rilvegostomig (Other)
• Tremelimumab (Checkpoint Inhibitor)

Participant Groups

Group I: Arm B Experimental Treatment 2 Interventions

Rilvegostomig, and bevacizumab

Group II: Arm A Experimental Treatment 3 Interventions

Tremelimumab , rilvegostomig and bevacizumab

Group III: Arm C Active Control 2 Interventions

Atezolizumab, and bevacizumab

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

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