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Clinical Trials List

Protocol NumberD7029C00001
NCT Number(ClinicalTrials.gov Identfier)NCT06921785
Active

2025-04-01 - 2030-06-18

Phase III

Recruiting8

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

  • Trial Applicant

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/10

Investigators and Locations

Principal Investigator Chen-Chun Lin Digestive System Department
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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 吳鴻昌 Division of Hematology & Oncology
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 Hung-Wei Wang Digestive System Department
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 Pin-Nan Cheng
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

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

Injectables
Injectables
Injectables

Active Ingredient

rilvegostomig

Dosage Form

270
270
270

Dosage

mg

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

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

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

The Estimated Number of Participants

  • Taiwan

    75 participants

  • Global

    1220 participants

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