Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma

Description

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

Interventions

Tremelimumab (Drug)
IV therapy
Rilvegostomig (Drug)
IV therapy
Bevacizumab (Drug)
IV therapy
Atezolizumab (Drug)
IV therapy

Eligibility 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 * 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. * 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 * History of significant bleeding disorders, vasculitis, or a significant bleeding episode from the GI tract within 6 months prior to study randomization. * Participants with untreated or incompletely treated varices with bleeding or high-risk (red wale signs or other high-risk factors) for bleeding. 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

Conditions

Hepatocellular Carcinoma

Locations

Research Site — Phoenix, Arizona, United States
Research Site — Tucson, Arizona, United States
Research Site — Los Angeles, California, United States
Research Site — Palo Alto, California, United States
Research Site — Denver, Colorado, United States
Research Site — New Haven, Connecticut, United States
Research Site — Newark, Delaware, United States
Research Site — Jacksonville, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Atlanta, Georgia, United States
Research Site — Honolulu, Hawaii, United States
Research Site — Chicago, Illinois, United States
Research Site — Indianapolis, Indiana, United States
Research Site — Shreveport, Louisiana, United States
Research Site — Detroit, Michigan, United States
Research Site — Grand Rapids, Michigan, United States
Research Site — Rochester, Minnesota, United States
Research Site — St Louis, Missouri, United States
Research Site — New Brunswick, New Jersey, United States
Research Site — New York, New York, United States
Research Site — New York, New York, United States
Research Site — New York, New York, United States
Research Site — Cleveland, Ohio, United States
Research Site — Oklahoma City, Oklahoma, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Pittsburgh, Pennsylvania, United States
Research Site — Amarillo, Texas, United States
Research Site — Austin, Texas, United States
Research Site — Dallas, Texas, United States
Research Site — Houston, Texas, United States
Research Site — San Antonio, Texas, United States
Research Site — Tyler, Texas, United States
Research Site — Arlington, Virginia, United States
Research Site — Salem, Virginia, United States
Research Site — Seattle, Washington, United States
Research Site — Milwaukee, Wisconsin, United States
Research Site — Camperdown, Australia
Research Site — Clayton, Australia
Research Site — Heidelberg, Australia
Research Site — Randwick, Australia
Research Site — South Brisbane, Australia
Research Site — Barretos, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Santa Maria, Brazil
Research Site — São Paulo, Brazil
Research Site — São Paulo, Brazil
Research Site — Vitória, Brazil
Research Site — Edmonton, Alberta, Canada
Research Site — Halifax, Nova Scotia, Canada
Research Site — Barrie, Ontario, Canada
Research Site — Brampton, Ontario, Canada
Research Site — Cambridge, Ontario, Canada
Research Site — Ottawa, Ontario, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Québec, Quebec, Canada
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Changchun, China
Research Site — Changsha, China
Research Site — Chengdu, China
Research Site — Chifeng, China
Research Site — Chongqing, China
Research Site — Deyang, China
Research Site — Fuzhou, China
Research Site — Guangzhou, China
Research Site — Guangzhou, China
Research Site — Guiyang, China
Research Site — Harbin, China
Research Site — Hefei, China
Research Site — Hohhot, China
Research Site — Kunming, China
Research Site — Linyi, China
Research Site — Lishui, China
Research Site — Luoyang, China
Research Site — Nanchang, China
Research Site — Nanchang, China
Research Site — Nanjing, China
Research Site — Nanning, China
Research Site — Nantong, China
Research Site — Neijiang, China
Research Site — Shandong, China
Research Site — Shanghai, China
Research Site — Shenyang, China
Research Site — Shenyang, China
Research Site — Weifang, China
Research Site — Wenzhou, China
Research Site — Wuhan, China
Research Site — Xi'an, China
Research Site — Zhengzhou, China
Research Site — Clichy, France
Research Site — Lille, France
Research Site — Lyon, France
Research Site — Montpellier, France
Research Site — Nantes, France
Research Site — Nice, France
Research Site — Pessac, France
Research Site — Rennes, France
Research Site — Toulouse, France
Research Site — Aachen, Germany
Research Site — Berlin, Germany
Research Site — Bonn, Germany
Research Site — Chemnitz, Germany
Research Site — Cologne, Germany
Research Site — Dortmund, Germany
Research Site — Dresden, Germany
Research Site — Erlangen, Germany
Research Site — Essen, Germany
Research Site — Frankfurt, Germany
Research Site — Frankfurt, Germany
Research Site — Göttingen, Germany
Research Site — Hamburg, Germany
Research Site — Hanover, Germany
Research Site — Leipzig, Germany
Research Site — Lübeck, Germany
Research Site — Magdeburg, Germany
Research Site — Moers, Germany
Research Site — Munich, Germany
Research Site — München, Germany
Research Site — Regensburg, Germany
Research Site — Ulm, Germany
Research Site — Hong Kong, Hong Kong
Research Site — Ahmedabad, India
Research Site — Bangalore, India
Research Site — Binnāguri, India
Research Site — Dehradun, India
Research Site — Delhi, India
Research Site — Hyderabad, India
Research Site — Mumbai, India
Research Site — Nashik, India
Research Site — Vadodara, India
Research Site — Bologna, Italy
Research Site — Milan, Italy
Research Site — Milan, Italy
Research Site — Palermo, Italy
Research Site — Perugia, Italy
Research Site — Pisa, Italy
Research Site — Roma, Italy
Research Site — Rozzano, Italy
Research Site — Bunkyō City, Japan
Research Site — Chiba, Japan
Research Site — Fukuoka, Japan
Research Site — Hiroshima, Japan
Research Site — Hiroshima, Japan
Research Site — Iizuka-shi, Japan
Research Site — Kashiwa, Japan
Research Site — Kita-gun, Japan
Research Site — Kobe, Japan
Research Site — Kōtoku, Japan
Research Site — Kumamoto, Japan
Research Site — Kurume-shi, Japan
Research Site — Kyoto, Japan
Research Site — Matsuyama, Japan
Research Site — Mitaka-shi, Japan
Research Site — Morioka, Japan
Research Site — Musashino-shi, Japan
Research Site — Nagoya, Japan
Research Site — Okayama, Japan
Research Site — Osaka, Japan
Research Site — Osakasayama-shi, Japan
Research Site — Saga, Japan
Research Site — Sapporo, Japan
Research Site — Sendai, Japan
Research Site — Suita-shi, Japan
Research Site — Tokyo, Japan
Research Site — Toyoake-shi, Japan
Research Site — Tsu, Japan
Research Site — Yokohama, Japan
Research Site — Yokohama, Japan
Research Site — Amsterdam, Netherlands
Research Site — Groningen, Netherlands
Research Site — Maastricht, Netherlands
Research Site — Rotterdam, Netherlands
Research Site — Utrecht, Netherlands
Research Site — Bydgoszcz, Poland
Research Site — Gdansk, Poland
Research Site — Koszalin, Poland
Research Site — Lublin, Poland
Research Site — Olsztyn, Poland
Research Site — Warsaw, Poland
Research Site — Busan, South Korea
Research Site — Goyang-si, South Korea
Research Site — Gyeonggi-do, South Korea
Research Site — Seongnam-si, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Barcelona, Spain
Research Site — Barcelona, Spain
Research Site — Madrid, Spain
Research Site — Madrid, Spain
Research Site — Madrid, Spain
Research Site — Santander, Spain
Research Site — Changhua, Taiwan
Research Site — Kaohsiung City, Taiwan
Research Site — Taichung, Taiwan
Research Site — Tainan, Taiwan
Research Site — Tainan County, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taoyuan, Taiwan
Research Site — Bangkok, Thailand
Research Site — Bangkok, Thailand
Research Site — Chiang Mai, Thailand
Research Site — Dusit, Thailand
Research Site — Hat Yai, Thailand
Research Site — Muang, Thailand
Research Site — Ubonratchathani, Thailand
Research Site — Altındağ, Turkey (Türkiye)
Research Site — Ankara, Turkey (Türkiye)
Research Site — Erzurum, Turkey (Türkiye)
Research Site — Istanbul, Turkey (Türkiye)
Research Site — Istanbul, Turkey (Türkiye)
Research Site — Izmir, Turkey (Türkiye)
Research Site — Cambridge, United Kingdom
Research Site — Leeds, United Kingdom
Research Site — London, United Kingdom
Research Site — London, United Kingdom
Research Site — London, United Kingdom
Research Site — Manchester, United Kingdom
Research Site — Hanoi, Vietnam
Research Site — Hanoi, Vietnam
Research Site — Ho Chi Minh City, Vietnam

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Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma

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Description

Interventions

Eligibility criteria

Conditions

Locations

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