Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)-China Extension Study
- Conditions
- Biliary Tract Carcinoma
- Interventions
- Registration Number
- NCT04924062
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B (Placebo+Gemcitabine+Cisplatin) Placebo Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. Arm A (Pembrolizumab+Gemcitabine+Cisplatin) Pembrolizumab Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. Arm B (Placebo+Gemcitabine+Cisplatin) Gemcitabine Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. Arm A (Pembrolizumab+Gemcitabine+Cisplatin) Gemcitabine Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. Arm A (Pembrolizumab+Gemcitabine+Cisplatin) Cisplatin Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. Arm B (Placebo+Gemcitabine+Cisplatin) Cisplatin Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to approximately 29 months 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.
- Secondary Outcome Measures
Name Time Method Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by BICR Up to approximately 29 months 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.
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE) Up to approximately 29 months 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.
Number of Participants Who Experience One or More Adverse Events (AE) Up to approximately 29 months 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.
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) Up to approximately 29 months 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.
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR Up to approximately 29 months 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.
Trial Locations
- Locations (22)
Anhui Provincial Hospital ( Site 0140)
🇨🇳Hefei, Anhui, China
Beijing Cancer Hospital ( Site 0138)
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital ( Site 0150)
🇨🇳Beijing, Beijing, China
First Affiliated Hospital of The Third Military Medical University ( Site 0130)
🇨🇳Chongqing, Chongqing, China
Fujian Provincial Cancer Hospital ( Site 0154)
🇨🇳Fuzhou, Fujian, China
Guangdong Provincial People s Hospital ( Site 0161)
🇨🇳Guangzhou, Guangdong, China
900 Hospital of the Joint ( Site 0137)
🇨🇳Fuzhou, Fujian, China
Harbin Medical University Cancer Hospital ( Site 0133)
🇨🇳Harbin, Heilongjiang, China
The Third Xiangya Hospital of Central South University ( Site 0157)
🇨🇳Changsha, Hunan, China
The First Hospital of Jilin University ( Site 0131)
🇨🇳Chanchun, Jilin, China
The 81st Hospital of PLA ( Site 0128)
🇨🇳Nanjing, Jiangsu, China
Hunan Provincial People Hospital ( Site 0142)
🇨🇳Changsha, Hunan, China
Hunan Cancer Hospital ( Site 0132)
🇨🇳Changsha, Hunan, China
Zhongshan Hospital Fudan University ( Site 0129)
🇨🇳Shanghai, Shanghai, China
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)
🇨🇳Shanghai, Shanghai, China
Tangdu Hospital ( Site 0146)
🇨🇳XI An, Shanxi, China
Fudan University Shanghai Cancer Center ( Site 0160)
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145)
🇨🇳XI An, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital ( Site 0155)
🇨🇳Tianjin, Tianjin, China
West China Hospital of Sichuan University ( Site 0147)
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital Zhejiang University ( Site 0136)
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0134)
🇨🇳Hangzhou, Zhejiang, China