NCT02829918

Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers

A Phase II Investigator Sponsored Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is designed to see if a drug called Nivolumab is effective in treating patients with advanced refractory biliary tract cancers. Nivolumab has been approved by the U.S. Food and Drug Administration (FDA) for treatment of certain types of cancer but is not approved by the FDA for treatment of your type of cancer.

Conditions

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Interventions

Type	Name	Description
DRUG	Nivolumab	Participants will receive nivolumab at a dose of 240 mg intravenously (IV) every 2 weeks (Q 2W) for 16 weeks (16W) and then 480 every 4 weeks (Q4W) from 17 weeks to end of study.

Timeline

• Start date: 2016-10-05
• Primary completion: 2019-03-27
• Completion: 2023-05-24
• First posted: 2016-07-12
• Last updated: 2026-03-11
• Results posted: 2020-03-30

Locations

3 sites across 1 country: United States