Study on Durvalumab or Tremelimumab Alone, or Combined with Tremelimumab or Bevacizumab for Advanced Liver Cancer
Sponsor: MedImmune LLC
ClinicalTrials ID:NCT02519348
This clinical trial is exploring different combinations of immunotherapy drugs, including Durvalumab and Tremelimumab, to see if they can help treat advanced liver cancer. The study aims to evaluate the safety and effectiveness of these treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to test the safety and effectiveness of different immunotherapy treatments for advanced liver cancer, known as hepatocellular carcinoma. The study will look at how well the drugs Durvalumab and Tremelimumab work alone or in combination with each other or with another drug called Bevacizumab. Researchers will monitor how the treatments affect the cancer and the body's immune response.
Description
This study is divided into several parts, each testing different treatment combinations for advanced liver cancer:
- In the first part, participants will receive Tremelimumab and Durvalumab in specific doses to check for safety and initial effectiveness.
- In the second part, participants will be randomly assigned to receive either Durvalumab alone, Tremelimumab alone, or a combination of both drugs.
- A separate group in China will follow the same treatment plan as the second part.
- In another part, participants will receive a single dose of Tremelimumab followed by regular doses of Durvalumab.
- In the third part, participants will be randomly assigned to different treatment groups, including Durvalumab alone or in combination with Tremelimumab at various doses.
- In the fourth part, participants will receive Durvalumab combined with Bevacizumab every three weeks.
Participants will continue treatment until their cancer progresses, they choose to stop, or other reasons arise. All participants will be monitored for survival until the study ends.
Eligibility Criteria
Inclusion Criteria
- Men and women aged 18 and older (20 and older in Japan).
- Diagnosed with advanced liver cancer confirmed by medical tests.
- Have not received immunotherapy before.
- Have tried or are unable to take other treatments like sorafenib or similar drugs, except for one specific group that has not had any prior treatment for liver cancer.
Exclusion Criteria
- Have had previous immune-based treatments.
- Have had liver-related brain issues or need medication to prevent them in the past year.
- Have had significant gastrointestinal bleeding in the past year.
- Have fluid buildup in the abdomen needing medical procedures in the past six months.
- Have a specific type of blood vessel blockage in the liver.
- Are receiving other cancer treatments.
- Have active or past autoimmune or inflammatory diseases, with some exceptions.
- Are using or have recently used medications that suppress the immune system, with some exceptions.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85054 | Phoenix | Arizona |
| Research Site | 94158 | San Francisco | California |
| Research Site | 06510 | New Haven | Connecticut |
| Research Site | 32224 | Jacksonville | Florida |
| Research Site | 33612 | Tampa | Florida |
| Research Site | 46202 | Indianapolis | Indiana |
| Research Site | 02114 | Boston | Massachusetts |
| Research Site | 10065 | New York | New York |
| Research Site | 11794 | Stony Brook | New York |
| Research Site | 27705 | Durham | North Carolina |
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