Phase III Study of Rilvegostomig in Combination with Bevacizumab with or without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma - ARTEMIDE-HCC01

Study identifier:D7029C00001

ClinicalTrials.gov identifier:NCT06921785

EudraCT identifier:N/A

CTIS identifier:2024-518210-81-00

Recruiting

Official Title

A Phase III, Randomised, Open-label, Sponsor-blinded, Multicentre Study of Rilvegostomig in Combination with Bevacizumab with or without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Medical condition

Hepatocellular Carcinoma

Phase

Phase 3

Healthy volunteers

Study drug

Tremelimumab, Rilvegostomig, Bevacizumab, Atezolizumab

Sex

All

Estimated Enrollment

1220

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 06 May 2025

Estimated Primary Completion Date: 16 Mar 2029

Estimated Study Completion Date: 14 Mar 2030

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2025 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

-Locally advanced or metastatic and/or unresectable HCC
-WHO/ECOG performance status of 0 or 1
-BCLC stage B (that is not eligible for locoregional therapy) or stage C.
Child-Pugh Score class A
-At least one measurable target lesion
-co-infected with HBV and HCV are not eligible
-Adequate organ and bone marrow function measured during the screening period
-Must not have received prior systemic therapy for intermediate, advanced, or metastatic HCC.
-Disease that is not amenable to curative surgical and/or locoregional therapies. For participants who received locoregional therapy for HCC, locoregional therapy must have been completed ≥ 28 days prior to the baseline scan for the current study.

Exclusion Criteria

Medical condition
-Any evidence of uncontrolled intercurrent diseases
-Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment
-History of another primary malignancy
-Persistent toxicities caused by previous anti-cancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
-Clinically meaningful ascites, pleural effusion, or pericardial effusion requiring non-pharmacologic intervention to maintain symptomatic control within 6 months prior to the first scheduled dose.
-History of active primary immunodeficiency or active infection
-History of hepatic encephalopathy
-Current or recent (within 10 days of first dose of study treatment) use of aspirin (≥ 325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol
-Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purposes is ineligible
Bleeding or other risks
HCC related
-Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
-Central nervous system metastases or spinal cord compression (including asymptomatic and adequately treated disease)
-Prior treatment with anti-CTLA-4 and/or anti-TIGIT.
-Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment

Sort by status

No locations available

Arms	Assigned Interventions
Experimental: Arm A Tremelimumab , rilvegostomig and bevacizumab	Drug: Tremelimumab IV therapy Drug: Rilvegostomig IV therapy Drug: Bevacizumab IV therapy
Experimental: Arm B Rilvegostomig, and bevacizumab	Drug: Rilvegostomig IV therapy Drug: Bevacizumab IV therapy
Active Comparator: Arm C Atezolizumab, and bevacizumab	Drug: Bevacizumab IV therapy Drug: Atezolizumab IV therapy

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]