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Protocol NumberD7029C00001
Active

2025-04-01 - 2030-06-18

Phase III

Recruiting8

A phase III, randomized, open-label, commissioner-blinded, multicenter trial evaluating ribegostomig in combination with bevacizumab, with or without tremelimumab, as first-line treatment for patients with advanced hepatocellular carcinoma (ARTEMIDE-HCC01).

  • Trial Applicant

  • Sponsor

    AstraZeneca Taiwan Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/08/05

Investigators and Locations

Principal Investigator Ying-Chun Shen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiang Huang Digestive System Department
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳彥豪 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇維文 Digestive System Department
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chen-Chun Lin
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced hepatocellular carcinoma

Objectives

Safety Implementation Phase: Primary Objective - To evaluate the safety and tolerability of rilvegostomig in combination with tremelimumab and bevacizumab in all prior-taught subjects. Secondary Objective - To demonstrate the efficacy of rilvegostomig in combination with tremelimumab and bevacizumab in all prior-taught subjects. Randomization Phase: Primary Objective - To demonstrate the efficacy of rilvegostomig in combination with tremelimumab and bevacizumab (Group A) compared to atezolizumab and bevacizumab (Group C) by assessing overall survival (OS) in subjects with advanced hepatocellular carcinoma (HCC). Key Secondary Objective - To demonstrate the efficacy of rilvegostomig and bevacizumab (Group B) compared to atezolizumab and bevacizumab (Group C) by assessing OS in subjects with advanced HCC.

Test Drug

Atezolizumab
Bevacizumab
Rilvegostomig (AZD2936)
Tremelimumab

Active Ingredient

Atezolizumab (Tecentriq) Concentrate for solution for infusion 60 mg/mL
BEVACIZUMAB
Rilvegostomig (AZD2936)
Tremelimumab

Dosage Form

Injectable
Injectable
Injectable
Injectable

Dosage

1200mg/20ml
16 mL/Vial (25 mg/mL)
750 mg
25 mg/Vial (1.25 mL/Vial) 或 300 mg/Vial (15 mL/Vial)

Endpoints

Safety Implementation Phase:

Primary Objective - To evaluate the safety and tolerability of rilvegostomig in combination with tremelimumab and bevacizumab in all prior-taught safety implementation subjects.

Randomization Phase:

Primary Objective - To demonstrate the efficacy of rilvegostomig in combination with tremelimumab and bevacizumab (Group A) compared to atezolizumab and bevacizumab (Group C) by assessing overall survival (OS) in subjects with advanced hepatocellular carcinoma (HCC).

Inclution Criteria

Safety Introduction Phase
Subjects are eligible for inclusion in this trial only if they meet all of the following criteria:
Age
1. Subjects must be 18 years of age or older, or the legal age of consent in the jurisdiction where the trial is conducted, when signing the subject consent form.
Subject Type and Disease Characteristics
2. Subjects have locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) confirmed by histopathological/cytological methods, or clinically confirmed using the American Association for the Study of Liver Diseases (AASLD) criteria for patients with cirrhosis.

(a) Subjects without cirrhosis require a histologically confirmed diagnosis.

3. Subjects have a WHO/East Coast Cancer Clinical Research Consortium (WHO/ECOG) performance status score of 0 or 1, and have not experienced exacerbations within the screening baseline and 2 weeks prior to randomization.

4. Subjects must not have previously received systemic therapy for intermediate, advanced, or metastatic HCC.

5. Subjects have a condition unsuitable for curative surgery and/or localized regional therapy. Subjects are eligible if they have recurrent/worsening disease following surgery and/or localized therapy. Subjects who have received approved adjuvant therapy (including immune checkpoint inhibitor therapy) must have a minimum 6-month interval between completion of such therapy and data showing a diagnosis of recurrent or metastatic disease. For subjects receiving localized therapy for HCC, the localized therapy must have been completed ≥ 28 days prior to the baseline scan of this trial.

6. Barcelona Clinical Hepatocellular Carcinoma (BCLC) Stage B (not eligible for localized therapy) or Stage C.

7. Child-Pugh score of A, and no progression within 2 weeks prior to the baseline screening period and randomization.

8. For the randomization period, a sufficient quantity of formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen (newly acquired specimen or specimen retained within ≤12 months prior to screening) must be provided for central PD-L1 testing prior to randomization.

9. At least one previously untreated, measurable target lesion that can be accurately measured at the baseline period and is suitable for accurate repeat measurement according to RECIST 1.1 guidelines. Lesions located within the scope of local therapy that subsequently worsen as defined in RECIST 1.1 following previous treatment are eligible.

10. Appropriate organ and bone marrow function is measured during the screening period (i.e., day -28 to day -1).

11. Subjects with active hepatitis B (HBV) infection (characterized by positive hepatitis B surface antigen (HBsAg) and/or anti-hepatitis B core antibody (anti-HBc) and detectable HBV deoxyribonucleic acid (DNA) [≥10 IU/mL or above the detection limit of their local laboratory]) must have received antiviral therapy for at least 14 days prior to randomization, in accordance with institutional practice, to demonstrate evidence of HBV stability or signs of viral response (e.g., decreased HBV DNA concentration) in order to be eligible for inclusion. Subjects must continue receiving antiviral therapy during the trial and for 6 months after the last dose of trial treatment. Subjects co-infected with HBV and hepatitis D virus (HDV) are ineligible (indicators of active HBV infection are the presence of HBsAg and/or anti-HBcAb and detectable HBV DNA; indicators of active HDV infection are detectable HDV-RNA and the presence/absence of anti-HDV antibodies).

12. Subjects with active hepatitis C (HCV) infection, as determined by the trial administrator, must be well-controlled in this trial according to local institutional practices. Subjects with active HCV infection must be diagnosed with HCV, characterized by detectable HCV RNA and the presence/absence of anti-HCV antibodies at enrollment. Subjects co-infected with HBV and HCV are ineligible (the presence of anti-HCV antibodies indicates HCV positive infection).

13. The life expectancy of subjects at screening must be at least 12 weeks.

Weight
14. Subjects must weigh ≥35 kg.

Gender and Contraception/Barrier Requirements

15. No gender preference.

Regarding contraceptive methods used by clinical trial participants, both male and female contraceptive methods should comply with local regulations.

(a) Male Participants:

• Unsterilized male participants who intend to have sexual intercourse with a fertile female partner must use an acceptable method of contraception from enrollment until 180 days after the last dose of tremelimumab, atezolizumab, or bevacizumab, and 90 days after the last dose of rilvegostomig.

(b) Female Participants:

• Infertile women.

• Women currently receiving hormone replacement therapy (HRT) with an unknown postmenopausal status who wish to continue HRT during the trial must use one of the highly effective contraceptive methods listed for women of fertility (WOCBP), or must discontinue HRT to confirm their postmenopausal status before randomization.

• Fertility-prone female participants who have not practiced complete abstinence and intend to have sexual intercourse with an unsterilized male partner must use at least one highly effective method of contraception from enrollment until at least 180 days after the last dose of tremelimumab, atezolizumab, and bevacizumab, and 90 days after the last dose of rilvegostomig. All WOCBP participants must have a negative serum pregnancy test result on day 1 of cycle 1; from screening until at least 180 days after the last dose of tremelimumab, atezolizumab, and bevacizumab, and 90 days after the last dose of rilvegostomig, they must not breastfeed, and must not donate or have their eggs collected for personal use.

(c) Pregnancy Test:

• All WOCBP participants must have a negative pregnancy test result at screening and before each administration of the investigational drug.

Informed Consent

16. Able to provide signed participant consent forms, including compliance with the participant consent form and the requirements and restrictions listed in this program.

Exclusion Criteria

Safety Introduction Phase
Subjects may not participate in the trial if they meet any of the following criteria:
Medical Conditions
1. Evidence of any poorly controlled interstitial disease (e.g., severe or poorly controlled systemic disease, including but not limited to active interstitial lung disease (ILD) or non-infectious pneumonia, severe chronic gastrointestinal disease with diarrhea (e.g., active inflammatory bowel disease), active non-infectious skin disease (including any grade of rash, urticaria, dermatitis, ulcers, or psoriasis requiring systemic treatment), or mental illness/social condition, and poorly controlled tumor-related pain, which the trial administrator deems unsuitable for participation in the trial or will affect adherence to the trial protocol.

2. History of allogeneic organ or stem cell transplantation, or being on the allogeneic organ transplant waiting list.

3. Having an active or previously documented autoimmune or inflammatory disease requiring long-term treatment with steroids or other immunosuppressive therapies (including but not limited to inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis). [Excluding diverticulosis, systemic lupus erythematosus, sarcoidosis syndrome, or Wegener's disease [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]]. Exceptions to this condition are:

(a) Subjects with vitiligo or hair loss.

(b) Subjects with hypothyroidism (e.g., occurring after Hashimoto's syndrome) and consistently receiving hormone replacement therapy.

(c) Any chronic skin condition that does not require systemic treatment.

(d) Subjects with a history of illness and no active disease in the past 5 years must be included after consultation with the trial physician.

(e) Subjects with celiac disease controlled solely by diet.

4. A history of another primary malignancy, excluding:

(a) Subjects who have received curative treatment and have no known active disease ≥5 years prior to the first dose of trial treatment. (a) Malignant tumors with a low risk of recurrence.

(b) Non-melanoma skin cancer or malignant lentigines that have been appropriately excised and have no evidence of disease.

(c) Carcinoma in situ that has been appropriately treated and has no evidence of disease.

5. History of active primary immunodeficiency or active infection (excluding HBV or HCV infection): including tuberculosis (clinical evaluation including clinical history, physical examination and radiographic findings, and tuberculosis testing in accordance with local practice) or human immunodeficiency virus (HIV) (HIV 1/2 antibody positive).

6. Persistent toxicities (excluding hair loss) caused by previous anticancer therapy that have not improved to ≤ Grade 1 or baseline status. Note: If the subject has the following chronic stable Grade 2 toxicities related to previous anticancer therapy as determined by the trial administrator (defined as not worsening to > Grade 2 within at least 3 months prior to the first dose of trial intervention, and under standard of care [SoC]) (Treatment/Management) Subjects who may be included include:

(a) Neuropathy caused by chemotherapy.

(b) Fatigue.

(c) Vitiligo.

(d) Endocrine disorders controlled by alternative hormone therapy.

(e) Subjects may be included if the trial administrator determines that the subject has irreversible toxicity (e.g., hearing loss) that is reasonably expected to be unaffected by the trial intervention.

7. History of leptomeningeal carcinoma.

8. Central nervous system metastases or spinal cord compression (including asymptomatic and appropriately treated conditions). If a subject is suspected of having brain metastases at screening, a brain MRI (preferred) or CT scan should be performed before enrollment in the trial, preferably with intravenous (iv) contrast agent.

9. Known allergy to rilvegostomig, tremelimumab, atezolizumab, and bevacizumab. 10. Allergy or allergic reaction to any new drug or any excipient of any medicine.

11. Clinically significant ascites, pleural effusion, or pericardial effusion requiring nonpharmacological intervention (e.g., paracentesis) to maintain symptom control within 6 months prior to the first scheduled dose. Eligibility is granted if the subject has received a stable dose of diuretics for ≥2 months due to effusion.

12. History of hepatic encephalopathy.

13. Known fibrolamellar HCC, sarcoma-like HCC, or mixed cholangiocarcinoma and HCC.

14. Liver volume ≥50% as determined by the trial administrator.

15. Any of the following bleeding risks:

(a) History of major bleeding disorders, vasculitis, or major gastrointestinal bleeding events within 6 months prior to randomization. Hemoptysis (≥2.5 mL of bright red blood per event) within 6 months prior to the start of trial treatment.

(b) Evidence of bleeding tendency or significant coagulation disorders. (c) Metastatic or involved disease of the major airways or blood vessels, or a large, centrally located mediastinal tumor less than 30 mm from the carina. Subjects with portal or hepatic vein vascular invasion may be included.

(d) Subjects with untreated or incompletely treated venous aneurysms with bleeding or a high risk of bleeding (red wale sign or other high-risk factors). Subjects must undergo esophagogastric-duodenal endoscopy (EGD) prior to enrollment, and all venous aneurysms (small to large) must be assessed and treated according to local standard of care (SoC). This procedure is not required if the subject has undergone EGD within 6 months prior to the start of the trial.

15. History of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation and/or fistula or intra-abdominal abscess within 6 months prior to the start of the trial.

16. History of intestinal obstruction and/or GI Clinical signs or symptoms of obstruction, including subobstructive disease, or the need for routine intravenous fluids, parenteral nutrition, or tube feeding prior to the start of trial treatment. Subjects with signs/symptoms of subobstruction/obstructive syndrome/intestinal obstruction at initial diagnosis and who have received decisive (surgical) treatment to relieve symptoms may be included.

17. Having a severe or non-healing wound, active peptic ulcer, or untreated fracture within 28 days prior to the start of trial treatment (except for asymptomatic vertebral compression fractures deemed unsuitable for treatment by the trial administrator).

18. Having experienced an arterial thrombotic event, including myocardial infarction, cerebrovascular accident, or transient ischemic attack, within 6 months prior to the start of trial treatment. Having had a major vascular disease (e.g., an aortic aneurysm requiring surgical repair or a recent peripheral artery thrombosis) within 6 months prior to the start of trial treatment.

19. Having deep vein thrombosis, pulmonary embolism, or any other major thromboembolism within 3 months prior to treatment allocation. (A history of thrombosis in venous prosthetics or catheters, or superficial venous thrombosis, is not considered major.)

20. Subjects with a baseline angiography showing a main portal vein tumor thrombosis (i.e., a thrombus in the main portal vein, regardless of blood flow).

21. A history of any kidney disease or nephrotic syndrome.

22. Any of the following cardiac conditions:

• Cardiomyopathy of any etiology, or a history of myocarditis

• Heart failure [defined as New York Heart Association Class III-IV]

• Poorly controlled hypertension: defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg (achieved with antihypertensive therapy); subjects with a history of hypertensive crisis or hypertensive encephalopathy are ineligible

• Unstable angina

• Clinically significant coronary, carotid, or peripheral artery stenosis

• 12 days prior to the start of trial treatment • Has experienced acute coronary syndrome/acute myocardial infarction and/or undergone percutaneous coronary intervention/coronary artery bypass surgery within the past 12 months.

• Has undergone arterial or peripheral vascular intervention within the past 12 months prior to the start of the trial treatment.

• Has ventricular arrhythmias requiring treatment, high-degree atrioventricular (AV) block (II-III), or sinoatrial node dysfunction with significant sinus arrest, and is not using pacemaker therapy. Note: If all other cardiac eligibility criteria are met and a cardiological evaluation confirms suitability for the trial treatment, clinically stable atrial fibrillation or flutter with ideally controlled ventricular rates (e.g., resting ECG or 24-hour Holter-ECG mean <100 bpm) is eligible.

• Has a history of QT interval prolongation associated with other medications that require discontinuation.

• Has congenital long QT syndrome, a family history of long QT syndrome, or a first-degree relative who has a history of long QT syndrome within the past 40 years. Unexplained sudden death in children under 6 years of age.

• Scheduled or scheduled cardiac surgery or percutaneous coronary intervention.

• Scheduled revascularization procedure within 6 months of the start of trial treatment.

Previous/Concomitant Therapies

23. Concurrent treatment with any chemotherapy, experimental therapy, biologic, or hormone therapy for cancer. Concurrent use of hormone therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. Previous treatment with anti-CTLA-4 and/or anti-T-cell immune receptor (TIGIT) therapy.

24. Received radiation therapy within 28 days prior to the start of trial treatment, and abdominal/pelvic radiation therapy within 60 days prior to the start of trial treatment, excluding palliative radiation therapy to bone lesions within 7 days prior to the start of trial treatment.

25. Received a live attenuated vaccine within 30 days prior to the first dose of trial treatment. Note that if enrolled, subjects should not receive a live vaccine during trial treatment and within 30 days after the last dose of trial treatment. 72 days prior to administration of the first dose of trial treatment. 26. Severe Special Infectious Pneumonia (COVID-19) vaccine should not be administered within 14 hours prior to the first dose of trial treatment.

27. Underwent a major surgical procedure (as defined by the trial administrator), open biopsy, or major trauma within 28 days prior to the first dose of trial treatment, or is expected to undergo a major surgical procedure during the trial. Underwent abdominal surgery, abdominal intervention, or major abdominal trauma within 60 days prior to the start of trial treatment, or is expected to undergo a major surgical procedure during the trial, or is unable to recover from any side effects of such procedures. Note that minor procedures performed on isolated lesions for palliative purposes may be accepted if performed more than 14 days before the first dose of trial treatment. Underwent a core needle biopsy or other minor surgical procedure within 3 days prior to the first dose of bevacizumab, excluding placement of vascular access devices.

28. Currently using, or having previously used, any of the following treatments within 14 days prior to the first dose of trial treatment. Use of immunosuppressive drugs within 3 days. Exceptions to this condition include:

(a) Intranasal, inhaled, or topical steroids, or local steroid injections (e.g., intra-articular injection).

(b) Systemic corticosteroids at physiological doses not exceeding 10 mg/day of prednisone or 2 mg/day of dexamethasone or equivalent drugs (excluding treatment for adverse events).

(c) Steroids as a prophylaxis for allergic reactions (e.g., prophylaxis for CT scans).

29. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to the start of trial treatment. Subjects receiving prophylactic antibiotics (e.g., for the prevention of urinary tract infections or COPD exacerbations) are eligible for the trial.

30. Current or recent (within 10 days prior to the first dose of trial treatment) use of aspirin (≥325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, or cilostazol.

31. Current or recent... (Within 10 days prior to the start of the trial treatment) Use of a full dose of oral or non-enteric anticoagulants or thrombolytics for therapeutic (not prophylactic) purposes does not qualify for participation; prophylactic anticoagulants or thrombolytics may be used as needed after discussion with the trial physician.

32. Long-term daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs). Occasional use of NSAIDs to relieve symptoms of medical conditions (e.g., headache or fever) is permitted. Low-dose aspirin (<325 mg/day) is permitted (strongly recommended in conjunction with hydrogen ion pump inhibitors to reduce potential GI damage).

Previous/Concurrent Clinical Trial Experience

33. Previous enrollment in a current trial.

34. Enrollment in another clinical trial and receiving the trial treatment or trial medical device within 4 weeks prior to the first dose of the trial treatment, or concurrent enrollment in another clinical trial, unless the trial is an observational (non-invasive) clinical trial or the subject is in the follow-up period of an invasive trial.

Other Exclusion Criteria

35. Participation in the planning and/or execution of this trial (applicable to AstraZeneca) 36. If a participant is deemed unlikely to comply with the trial procedures, limitations, and requirements by the trial administrator, that participant should not participate in the trial.

Note: For participants ≥65 years of age, the use of geriatric screening tools and/or formal geriatric assessments (e.g., comprehensive geriatric assessment [CGA]) should be considered prior to randomization, in accordance with local or national guidelines. For participants ≥80 years of age, a formal geriatric assessment (e.g., CGA) is strongly recommended prior to randomization unless required by local or national guidelines.

37. Pregnant or breastfeeding women, or women who intend to become pregnant during the trial.

The Estimated Number of Participants

  • Taiwan

    75 participants

  • Global

    1220 participants

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