Study on New Immune System Drugs Alone and with Cancer Treatments for Advanced Liver and Bile Duct Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT05775159
This clinical trial is testing new drugs that affect the immune system, both by themselves and with other cancer treatments, to see if they are safe and effective for people with advanced liver and bile duct cancers.
Patient Parameters
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Program Overview
The GEMINI-Hepatobiliary study is exploring new drugs that work with the immune system to treat advanced liver and bile duct cancers. The study will look at how well these drugs work on their own and when combined with other cancer treatments. Researchers aim to find out if these new treatments are safe and can help control the cancer.
Description
This study is in Phase II and involves testing new immune system drugs, Volrustomig and Rilvegostomig, for people with advanced liver and bile duct cancers. The study is open-label, meaning both the researchers and participants know what treatment is being given. It is conducted at multiple centers and does not have a control group.
The study is divided into different parts, called substudies. In Substudy 1, about 200 participants with advanced liver cancer will receive either Volrustomig or Rilvegostomig alone or with other cancer drugs to see how well they work. In Substudy 2, about 60 participants with advanced bile duct cancer, who have not had previous treatment for their advanced cancer, will receive Rilvegostomig or Volrustomig along with gemcitabine and cisplatin to test their effectiveness and safety.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must sign a consent form agreeing to participate.
- Must have a confirmed diagnosis of advanced or metastatic solid tumor as specified in the study.
- Must have good organ and bone marrow function.
- Must have at least one measurable tumor that has not been treated with radiation.
- Must have a life expectancy of at least 12 weeks.
- Must be willing to provide a tumor sample for the study.
Exclusion Criteria
- Have had an organ transplant from another person.
- Have active or past autoimmune or inflammatory diseases.
- Have uncontrolled illnesses.
- Have had another type of cancer, cancer in the brain or spinal cord, or a primary immune deficiency.
- Have an active infection or cancer that has spread to the brain or spinal cord.
- Are co-infected with hepatitis B and D.
- Have already been treated in this study.
- For Substudy 1, have had liver-related brain issues in the past year.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 35233 | Birmingham | Alabama |
| Research Site | 92627 | Costa Mesa | California |
| Research Site | 90089 | Los Angeles | California |
| Research Site | 92868 | Orange | California |
| Research Site | 33140 | Miami Beach | Florida |
| Research Site | 46311 | Dyer | Indiana |
| Research Site | 66103 | Kansas City | Kansas |
| Research Site | 10065 | New York | New York |
| Research Site | 75251 | Dallas | Texas |
| Research Site | 22031 | Fairfax | Virginia |
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