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

Biliary Tract Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

• NCT number: NCT04057365
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Terminated
• Phase: Phase 2
• Start date: October 7, 2019
• Completion date: September 25, 2022