This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,069
Pembrolizumab by intravenous (IV) infusion
Gemcitabine by IV infusion
Cisplatin by IV infusion
Overall Survival (OS)
Overall survival was defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 38 months
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR)
PFS was defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 was presented.
Time frame: Up to approximately 26 months
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters \[SOD\] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ.
Time frame: Up to approximately 26 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.
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Placebo to pembrolizumab
University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016)
Birmingham, Alabama, United States
University of California San Diego Moores Cancer Center ( Site 0008)
La Jolla, California, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0014)
Los Angeles, California, United States
University of California - San Francisco ( Site 0030)
San Francisco, California, United States
University of Colorado Hospital ( Site 0011)
Aurora, Colorado, United States
Hartford Hospital ( Site 0057)
Hartford, Connecticut, United States
Yale University ( Site 0053)
New Haven, Connecticut, United States
Winship Cancer Institute of Emory University ( Site 0013)
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers PC ( Site 0045)
Marietta, Georgia, United States
Decatur Memorial Hospital ( Site 0056)
Decatur, Illinois, United States
...and 175 more locations
Time frame: Up to approximately 38 months
Number of Participants Who Experience One or More Adverse Events (AE)
An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. Number of participants who experienced one or more AEs were reported.
Time frame: Up to approximately 65 months
Number of Participants Who Discontinued Study Intervention Due to an AE
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurs during the course of the study. Number of participants who discontinued study intervention due to an AE were reported.
Time frame: Up to approximately 63 months