Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
NCT ID: NCT05775159
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
294 participants
INTERVENTIONAL
2023-04-24
2027-10-28
Brief Summary
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Detailed Description
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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 90 evaluable participants with advanced BTC who have not received previous treatment for advanced/metastatic disease.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1A
Volrustomig monotherapy
Volrustomig
CTLA-4/Anti-PD-1 Bispecific Antibody
Cohort 1B
Volrustomig combination with bevacizumab
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.
Cohort 1C
Volrustomig combination with lenvatinib
Volrustomig
CTLA-4/Anti-PD-1 Bispecific Antibody
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.
Cohort 2A
Rilvegostomig combination with Gemcitabine and Cisplatin
Rilvegostomig
anti- PD-1 and TIGIT bispecific antibody
Gemcitabine
1000 mg/m2, IV infusion
Cisplatin
25 mg/m2, IV infusion
Cohort 2B
Volrustomig combination with Gemcitabine and Cisplatin
Volrustomig
CTLA-4/Anti-PD-1 Bispecific Antibody
Gemcitabine
1000 mg/m2, IV infusion
Cisplatin
25 mg/m2, IV infusion
Cohort 1D
Volrustomig combination with rilvegostomig and bevacizumab
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.
Rilvegostomig
anti- PD-1 and TIGIT bispecific antibody
Cohort 1E
Rilvegostomig combination with bevacizumab
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.
Rilvegostomig
anti- PD-1 and TIGIT bispecific antibody
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Provision of a signed and dated written ICF.
* Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology.
* Adequate organ and bone marrow function.
* At least 1 measurable not previously irradiated lesion per RECIST 1.1
* Life expectancy of at least 12 weeks at the time of screening.
* Willing and able to provide an adequate tumor sample.
Exclusion Criteria
* Active or prior documented autoimmune or inflammatory disorders.
* Uncontrolled intercurrent illness.
* History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency.
* Active infection, brain metastases or spinal cord compression.
* Participants co-infected with HBV and hepatitis D virus (HDV).
* Previous treatment in the present study.
* For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Costa Mesa, California, United States
Research Site
Los Angeles, 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
Florence, , Italy
Research Site
Milan, , Italy
Research Site
Napoli, , Italy
Research Site
Rozzano, , Italy
Research Site
Chūōku, , Japan
Research Site
Kashiwa, , Japan
Research Site
Yokohama, , Japan
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
Pamplona, , Spain
Research Site
Kaohsiung City, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Liuying, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Cambridge, , United Kingdom
Research Site
Edinburgh, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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D7987C00001
Identifier Type: -
Identifier Source: org_study_id
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