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 Status: Recruiting
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Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Participation Requirements View:
Inclusion Criteria
Exclusion 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
• Participants with active HBV infection must receive antiviral therapy for a minimum of 14 days prior to randomization to show evidence of HBV stabilization or signs of viral response.
• Participants with active HCV infection must be well controlled. Participants 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.
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Phoenix
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Tucson
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Palo Alto
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Santa Monica
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New Haven
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Newark
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Jacksonville
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Atlanta
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Atlanta
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Honolulu
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Chicago
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Indianapolis
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Shreveport
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Detroit
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Grand Rapids
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Rochester
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St Louis
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New Brunswick
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New York
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New York
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New York
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Cleveland
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Oklahoma City
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Philadelphia
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Pittsburgh
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Amarillo
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Austin
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Dallas
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Houston
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Milwaukee
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Camperdown
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Clayton
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Heidelberg
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Barretos
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Porto Alegre
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Santa Maria
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Vitória
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Barrie
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Brampton
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Cambridge
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Edmonton
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Halifax
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Montreal
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Ottawa
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Québec
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Toronto
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Beijing
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Beijing
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Beijing
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Changchun
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Changsha
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Chengdu
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Chengdu
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Chifeng
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Chongqing
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Deyang
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Fuzhou
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Guangzhou
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Guangzhou
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Guiyang
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Harbin
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Hefei
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Kunming
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Linyi
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Luoyang
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Nanchang
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Nanchang
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Nanjing
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Nanning
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Nantong
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Neijiang
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Shandong
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Shanghai
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Shenyang
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Weifang
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Wenzhou
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Wuhan
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Xi'an
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Zhengzhou
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Clichy
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Lille
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Lyon
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Nantes
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Nice
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Pessac
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Rennes
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Toulouse
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Aachen
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Berlin
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Bonn
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Dortmund
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Dresden
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Essen
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Frankfurt
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Frankfurt
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Göttingen
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Hamburg
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Hanover
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Leipzig
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Lübeck
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Magdeburg
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Moers
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München
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Regensburg
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Ulm
Hong Kong Special Administrative Region
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Hong Kong
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Shatin
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Ahmedabad
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Bangalore
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Binnāguri
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Mumbai
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Bologna
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Pisa
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Roma
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Chiba
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Tsu
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Amsterdam
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Groningen
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Maastricht
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Lublin
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Warsaw
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Busan
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Seoul
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Santander
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Changhua
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Kaohsiung City
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Taichung
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Tainan
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Tainan County
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Taipei
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Taipei
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Taoyuan
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Bangkok
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Bangkok
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Chiang Mai
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Dusit
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Hat Yai
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Muang
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Ubonratchathani
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Altındağ
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Ankara
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Erzurum
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Istanbul
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Izmir
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Cambridge
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Leeds
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London
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London
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London
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Manchester
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Hanoi
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Hanoi
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Ho Chi Minh City
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Ho Chi Minh City
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Start Date: 2025-05-06
Estimated Completion Date: 2030-03-15
Target number of participants: 1220
Experimental: Arm A
Tremelimumab , rilvegostomig and bevacizumab
Experimental: Arm B
Rilvegostomig, and bevacizumab
Active_comparator: Arm C
Atezolizumab, and bevacizumab