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
Location: See all (196) locations...
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
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NOT_YET_RECRUITING
Phoenix
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Tucson
California
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RECRUITING
Palo Alto
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Santa Monica
Connecticut
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New Haven
Delaware
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Newark
Florida
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Jacksonville
Georgia
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Atlanta
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Fayetteville
Illinois
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Chicago
Michigan
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Detroit
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RECRUITING
Grand Rapids
Minnesota
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Rochester
New Jersey
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RECRUITING
New Brunswick
New York
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New York
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New York
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New York
Ohio
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Cleveland
Oklahoma
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SUSPENDED
Oklahoma City
Pennsylvania
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NOT_YET_RECRUITING
Pittsburgh
Texas
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Austin
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Dallas
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El Paso
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Houston
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San Antonio
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Tyler
Virginia
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Blacksburg
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Fairfax
Wisconsin
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Milwaukee
Other Locations
Australia
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Auchenflower
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Camperdown
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Heidelberg
Brazil
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RECRUITING
Porto Alegre
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NOT_YET_RECRUITING
Santa Maria
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RECRUITING
São Paulo
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NOT_YET_RECRUITING
São Paulo
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Vitória
Canada
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NOT_YET_RECRUITING
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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RECRUITING
Toronto
China
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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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Chifeng
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Chongqing
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RECRUITING
Deyang
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NOT_YET_RECRUITING
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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Hohhot
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Kunming
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NOT_YET_RECRUITING
Linyi
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RECRUITING
Lishui
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NOT_YET_RECRUITING
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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NOT_YET_RECRUITING
Shenyang
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Shenyang
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Weifang
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RECRUITING
Wenzhou
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Wuhan
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Xi'an
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Zhengzhou
France
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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
Germany
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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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WITHDRAWN
Regensburg
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Ulm
Hong Kong Special Administrative Region
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RECRUITING
Hong Kong
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RECRUITING
Shatin
India
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Ahmedabad
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Bangalore
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Binnāguri
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Dehradun
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Delhi
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Hyderabad
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Mumbai
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Nashik
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Vadodara
Italy
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Bologna
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Milan
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Milan
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Palermo
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Perugia
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Pisa
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Roma
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Rozzano
Japan
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Bunkyō City
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Chiba
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Fukuoka
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Hiroshima
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Hiroshima
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Iizuka-shi
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Kashiwa
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Kita-gun
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Kobe
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Kōtoku
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Kumamoto
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Kurume-shi
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Kyoto
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Matsuyama
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Mitaka-shi
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Morioka
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Musashino-shi
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Nagoya
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Okayama
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Osaka
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Osakasayama-shi
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Saga
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Sapporo
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Sendai
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Suita-shi
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Tokyo
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Toyoake-shi
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Tsu
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Yokohama
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Yokohama
Netherlands
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Amsterdam
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Groningen
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Maastricht
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Rotterdam
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Utrecht
Republic of Korea
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Busan
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Goyang-si
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Gyeonggi-do
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Seongnam-si
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Seoul
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Seoul
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Seoul
Spain
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Barcelona
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Barcelona
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Madrid
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Madrid
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Madrid
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Santander
Taiwan
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Changhua
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NOT_YET_RECRUITING
Kaohsiung City
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NOT_YET_RECRUITING
Taichung
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Tainan
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NOT_YET_RECRUITING
Tainan County
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RECRUITING
Taipei
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Taipei
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RECRUITING
Taoyuan District
Thailand
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NOT_YET_RECRUITING
Bangkok
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Bangkok
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NOT_YET_RECRUITING
Chiang Mai
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Dusit
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NOT_YET_RECRUITING
Hat Yai
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NOT_YET_RECRUITING
Muang
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Ubonratchathani
Turkey
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Altındağ
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NOT_YET_RECRUITING
Ankara
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Erzurum
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Istanbul
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Izmir
Viet Nam
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NOT_YET_RECRUITING
Hanoi
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NOT_YET_RECRUITING
Ho Chi Minh City
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-05-06
Estimated Completion Date: 2030-03-14
Participants
Target number of participants: 1220
Treatments
Experimental: Arm A
Tremelimumab , rilvegostomig and bevacizumab
Experimental: Arm B
Rilvegostomig, and bevacizumab
Active_comparator: Arm C
Atezolizumab, and bevacizumab
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov