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Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer

NCT05775159

Active Not RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: Hepatocellular Carcinoma, Biliary Tract Cancer

Interventions: Volrustomig, Bevacizumab, Lenvatinib, Rilvegostomig, Gemcitabine

Countries: United States, China, Hong Kong, Italy, Japan, South Korea, Spain, Taiwan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Age ≥18 years at the time of signing the ICF.
* 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:

* History of allogeneic organ transplantation.
* 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.
Locations (46)
  • Birmingham, Alabama, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • Kansas City, Kansas, United States
  • New York, New York, United States
  • Beijing, China
  • Beijing, China
  • Beijing, China
  • Chengdu, China
  • Chengdu, China
  • Chongqing, China
  • Fuzhou, China
  • Guangzhou, China
  • Guangzhou, China
  • Harbin, China
  • Nanning, China
  • Shanghai, China
  • Hong Kong, Hong Kong
  • Shatin, Hong Kong
  • Florence, Italy
  • Milan, Italy
  • Naples, Italy
  • Rozzano, Italy
  • Chūōku, Japan
  • Kashiwa, Japan
  • Yokohama, Japan
  • Seongnam-si, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • + 16 more on CT.gov