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Clinical Trial 18684
Cancer Type: Gastrointestinal Tumor
Interventions:BMS-936558 (Nivolumab); Nivolumab
Study Type: Treatment
Phase of Study: Phase II
- Richard Kim
A Phase II Investigator Sponsored Study of Nivolumab in Patients with Advanced Refractory Biliary Tract Cancers
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.
Primary Objective: The primary endpoint will be overall response rate (ORR). ORR is defined as complete responses (CR) plus partial responses (PR). Secondary Objectives: To determine the frequency and severity of adverse events and tolerability of the regimen in patients with advanced refractory BC receiving nivolumab. To determine the progression-free survival (PFS) in patients with advanced refractory BC receiving nivolumab. PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. To determine the overall survival in patients with advanced refractory BC receiving nivolumab. To determine the overall response rate by the immune response criteria.