Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04057365
Status:
TERMINATED
Last Update Posted:
2024-04-10
First Post:
2019-08-13
Brief Title:
Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer BTC
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer BTC
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on a Simon 2-stage design this study did not meet response criteria to proceed to stage 2
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research is studying the effect of the combination of how two study drugs Nivolumab and DKN-01 works in people with advanced biliary tract cancer
Detailed Description:
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved DKN-01 as a treatment for any disease
The FDA has not approved nivolumab for this specific disease but it has been approved for other cancers
DKN-01 and nivolumab are both antibodies An antibody is a protein that attaches to other cells to fight off infection DKN-01 is believed to work by attaching to and inhibiting stopping a specific pathway in the cells that is responsible for processes such as cell growth Nivolumab is believed to work by attaching to and inhibiting a specific protein in the cancer that controls parts of the immune system the system in the body that fights off infections and diseases by shutting down certain immune responses The investigators believe that nivolumab will inhibit the protein thus allowing the immune cells to recognize and destroy cancer cells
The US Food and Drug Administration FDA has not approved DKN-01 as a treatment for any disease
The FDA has not approved nivolumab for this specific disease but it has been approved for other cancers
DKN-01 and nivolumab are both antibodies An antibody is a protein that attaches to other cells to fight off infection DKN-01 is believed to work by attaching to and inhibiting stopping a specific pathway in the cells that is responsible for processes such as cell growth Nivolumab is believed to work by attaching to and inhibiting a specific protein in the cancer that controls parts of the immune system the system in the body that fights off infections and diseases by shutting down certain immune responses The investigators believe that nivolumab will inhibit the protein thus allowing the immune cells to recognize and destroy cancer cells
Study Oversight
Has Oversight DMC:
None
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?:
None