Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers

Part of paid clinical trials in Duarte, California.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT02829918
Phase
PHASE2
Status
Completed

Conditions

  • Biliary Tract Cancer
  • Biliary Tract Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — 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.

Study Details

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.

Key Dates

Start date
Oct 5, 2016
Status verified
Feb 2026
Primary completion
Mar 27, 2019
Completion
May 24, 2023

Study Design

Enrollment
54 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab Treatment
    This is a single arm study with two stage design using nivolumab in advanced biliary tract cancer (BTC), for participants who have failed or are intolerant to at least one line of therapy and no more than 2 lines of therapy. In the first stage, 18 participants will be accrued. If there is at least one response (or several participants with stable disease based on the study team's discretion), an additional 34 patients will be accrued for a total of 52 patients.

Primary Outcome Measure

Overall Response Rate (ORR) After 4 Cycles of Treatment [ Time Frame: 16 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Cancer CenterDuarteCalifornia91010-
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Emory University Winship Cancer InstituteAtlantaGeorgia30322-

Find similar trials in Duarte, CA

By research site
City of Hope Cancer Center· Duarte, CAH. Lee Moffitt Cancer Center and Research Institute· Tampa, FLEmory University Winship Cancer Institute· Atlanta, GA

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