In this China Extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in Chinese adults 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).
The China extension study will include participants previously enrolled in China in the global study for MK-3475-966 (NCT04003636) plus those enrolled during the China extension enrollment period. A total of approximately 158 Chinese participants will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
158
Pembrolizumab by intravenous (IV) infusion
Gemcitabine by IV infusion
Cisplatin by IV infusion
Placebo to pembrolizumab
Anhui Provincial Hospital ( Site 0140)
Hefei, Anhui, China
Beijing Cancer Hospital ( Site 0138)
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital ( Site 0150)
Beijing, Beijing Municipality, China
First Affiliated Hospital of The Third Military Medical University ( Site 0130)
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital ( Site 0154)
Fuzhou, Fujian, China
900 Hospital of the Joint ( Site 0137)
Fuzhou, Fujian, China
Guangdong Provincial People s Hospital ( Site 0161)
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital ( Site 0133)
Harbin, Heilongjiang, China
Hunan Provincial People Hospital ( Site 0142)
Changsha, Hunan, China
Hunan Cancer Hospital ( Site 0132)
Changsha, Hunan, China
...and 12 more locations
Overall Survival (OS)
Overall survival was defined as the time from randomization to death due to any cause. Per protocol the final reported outcome for OS did not include any sensitivity or supportive analysis.
Time frame: Up to approximately 29 months
Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by BICR
Progression-free survival was defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurred first.
Time frame: Up to approximately 29 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 had 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 29 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
For participants who demonstrated a confirmed CR or PR, DOR was the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first.
Time frame: Up to approximately 29 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.
Time frame: Up to approximately 29 months
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (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 occurred during the course of the study.
Time frame: Up to approximately 29 months
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