Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers
NCT02829918 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2026-03-11
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
- DRUG
-
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.
Sponsors & Collaborators
- collaborator INDUSTRY
-
H. Lee Moffitt Cancer Center and Research Institute
lead OTHER
Principal Investigators
-
Richard Kim, M.D. · H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-05
- Primary Completion
- 2019-03-27
- Completion
- 2023-05-24
Countries
- United States
Study Locations
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