Spots Global Cancer Trial Database for Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
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Trial Identification
Brief Title: Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
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)
Study ID: NCT05775159
Study Description
Brief 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.
Detailed Description: This Phase II, open-label, uncontrolled, multicentre study evaluating the preliminary efficacy and safety of Volrustomig or Rilvegostomig as monotherapy (MONO) and/or in combination with anticancer agents (COMBO) in participants with advanced hepatobiliary cancer (e.g., HCC, BTC, etc.). This study has a modular design with independent substudies. In Substudy 1, Volrustomig and Rilvegostomig will be evaluated as monotherapy and/or in combination with other anticancer drugs in approximately 200 evaluable participants with advanced HCC. In Substudy 2, the efficacy and safety of Rilvegostomig or Volrustomig plus gemcitabine and cisplatin are investigated in approximately 60 evaluable participants with advanced BTC who have not received previous treatment for advanced/metastatic disease.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Birmingham, Alabama, United States
Research Site, Costa Mesa, California, United States
Research Site, Orange, California, United States
Research Site, Miami Beach, Florida, United States
Research Site, Dyer, Indiana, United States
Research Site, Kansas City, Kansas, United States
Research Site, New York, New York, United States
Research Site, Dallas, Texas, United States
Research Site, Fairfax, Virginia, United States
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Chengdu, , China
Research Site, Chengdu, , China
Research Site, Chongqing, , China
Research Site, Fuzhou, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Harbin, , China
Research Site, Hefei, , China
Research Site, Hefei, , China
Research Site, Hefei, , China
Research Site, Nanchang, , China
Research Site, Nanning, , China
Research Site, Shandong, , China
Research Site, Shanghai, , China
Research Site, Xi'an, , China
Research Site, Zhengzhou, , China
Research Site, Hong Kong, , Hong Kong
Research Site, Shatin, , Hong Kong
Research Site, Firenze, , Italy
Research Site, Milano, , Italy
Research Site, Napoli, , Italy
Research Site, Rozzano, , Italy
Research Site, Chuo-ku, , Japan
Research Site, Kashiwa, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Seongnam-Si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Pamplona, , Spain
Research Site, Kaohsiung city, , Taiwan
Research Site, Kaohsiung, , Taiwan
Research Site, Liuying, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan City, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan, , Taiwan
Research Site, Cambridge, , United Kingdom
Research Site, Edinburgh, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Contact Details
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