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Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
Sponsor: AstraZeneca
Summary
GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.
Official title: A Phase II, Open-Label, Multi-Drug, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
294
Start Date
2023-04-24
Completion Date
2027-10-28
Last Updated
2026-02-18
Healthy Volunteers
No
Interventions
Volrustomig
CTLA-4/Anti-PD-1 Bispecific Antibody
Bevacizumab
15 mg/kg, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
Lenvatinib
Daily use per oral (8 mg capsules/day for participants \< 60 kg or 12 mg/day for participants ≥ 60 kg) of 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
Rilvegostomig
anti- PD-1 and TIGIT bispecific antibody
Gemcitabine
1000 mg/m2, IV infusion
Cisplatin
25 mg/m2, IV infusion
Locations (60)
Research Site
Birmingham, Alabama, United States
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Costa Mesa, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Miami Beach, Florida, United States
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Dyer, Indiana, United States
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Kansas City, Kansas, United States
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New York, New York, United States
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Dallas, Texas, United States
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Fairfax, Virginia, United States
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Beijing, China
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Beijing, China
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Beijing, China
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Chengdu, China
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Chengdu, China
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Chongqing, China
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Fuzhou, China
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Guangzhou, China
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Guangzhou, China
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Harbin, China
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Hefei, China
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Hefei, China
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Hefei, China
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Nanchang, China
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Nanning, China
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Shandong, China
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Shanghai, China
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Xi'an, China
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Zhengzhou, China
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Hong Kong, Hong Kong
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Shatin, Hong Kong
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Florence, Italy
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Milan, Italy
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Naples, Italy
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Rozzano, Italy
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Chūōku, Japan
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Kashiwa, Japan
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Yokohama, Japan
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Seongnam-si, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Pamplona, Spain
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Kaohsiung City, Taiwan
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Kaohsiung City, Taiwan
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Liuying, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Cambridge, United Kingdom
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Edinburgh, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom