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A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC)

2019-08-20 20:17:13 | BioPortfolio

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.

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 U.S. 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 Design

Conditions

Biliary Tract Cancer

Intervention

Nivolumab, DKN-01

Location

Massachusetts General Hospital Cancer Center
Boston
Massachusetts
United States
02114

Status

Not yet recruiting

Source

Massachusetts General Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-08-20T20:17:13-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer in the BILIARY TRACT including the BILE DUCTS and the GALLBLADDER.

Abnormal passage in any organ of the biliary tract or between biliary organs and other organs.

Diseases in any part of the BILIARY TRACT including the BILE DUCTS and the GALLBLADDER.

Chronic inflammatory disease of the BILIARY TRACT. It is characterized by fibrosis and hardening of the intrahepatic and extrahepatic biliary ductal systems leading to bile duct strictures, CHOLESTASIS, and eventual BILIARY CIRRHOSIS.

Any surgical procedure performed on the biliary tract.

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