The purpose of this trial is to evaluate the effect of investigational drug nivolumab in combination with either gemcitabine/cisplatin chemotherapy, or in combination with another investigational agent ipilimumab in patients with advanced unresectable biliary tract cancer. Gemcitabine/cisplatin is the standard of care treatment for biliary tract cancer. Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab (Opdivo) is FDA approved for the treatment of several cancers including metastatic melanoma, advanced lung, kidney, head \& neck and bladder cancer. The combination of nivolumab and ipilimumab (Yervoy) is FDA approved for metastatic melanoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Gemcitabine 1000 mg/m2 IV
Cisplatin 25 mg/m2 IV
Ipilimumab 1 mg/kg IV
Nivolumab 360 mg or 240 mg IV
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
The Percentage of Patients Alive and Without Progression at 6 Months Following the Initiation of Treatment
The primary endpoint is PFS (Progression Free Survival) at 6 months following the initiation of treatment. Progression will be defined clinically or on imaging as per immune related response evaluation criteria in solid tumors (irRECIST) definition.
Time frame: 6 Months
Median Progression Free Survival Time
The median time patients are alive without progression following the initiation of treatment wherein progression will be defined clinically or on imaging as per irRECIST criteria.
Time frame: Patients will be followed until death, withdrawal from study, or until 2 years, whichever is earliest
Median Overall Survival Time
The median overall survival time following the initiation of treatment.
Time frame: Patients will be followed until death, withdrawal from study, or until 2 years, whichever is earliest
Overall Response Rate (ORR)
Overall Response Rate will be determined as per the combined RECIST v1.1 and irRECIST criteria
Time frame: Up to two years
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