Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT03482102
Status:
RECRUITING
Last Update Posted:
2022-09-08
First Post:
2018-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer
Status:
RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is studying a combination of drugs as a possible treatment for Hepatocellular Carcinoma or Biliary Tract Cancer.
The interventions involved in this study are:
* Durvalumab
* Tremelimumab
* Radiation Therapy
The interventions involved in this study are:
* Durvalumab
* Tremelimumab
* Radiation Therapy
Detailed Description:
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied.
The FDA (the U.S. Food and Drug Administration) has not approved durvalumab for this specific disease but it has been approved for other uses.
The FDA has not approved tremelimumab as a treatment for any disease.
Both durvalumab and tremelimumab are antibodies (proteins that work with the immune system) that target proteins produced by the cancer cells. These cancerous proteins suppress the immune system which allows the cancer cells to grow. The study drugs may target these cancerous proteins and stop the cancer cells from suppressing the immune system.
The investigators hope that the combination of these study drugs with radiation therapy will help stop the cancer cells from growing and spreading.
The FDA (the U.S. Food and Drug Administration) has not approved durvalumab for this specific disease but it has been approved for other uses.
The FDA has not approved tremelimumab as a treatment for any disease.
Both durvalumab and tremelimumab are antibodies (proteins that work with the immune system) that target proteins produced by the cancer cells. These cancerous proteins suppress the immune system which allows the cancer cells to grow. The study drugs may target these cancerous proteins and stop the cancer cells from suppressing the immune system.
The investigators hope that the combination of these study drugs with radiation therapy will help stop the cancer cells from growing and spreading.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: