Clinical trial NCT04924062: 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
Official title: A Phase 3 Randomized, Double Blind 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Biliary Tract Carcinoma
Keywords: Programmed cell death 1 (PD-1)
Pembrolizumab
Cholangiocarcinoma
Gallbladder cancer
Checkpoint inhibitor
Immunotherapy
Biliary
Keytruda
Bile Duct Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-06-11
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

* Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator
* Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
* Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
* Has a life expectancy of greater than 3 months
* Has adequate organ function

Exclusion Criteria

* Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer)
* Has ampullary cancer
* Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms
* Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
* Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator
* Has had an allogenic tissue/solid organ transplant

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 29 months
Secondary outcomes:
measure: Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 29 months
measure: 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)
timeFrame: Up to approximately 29 months
measure: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 29 months
measure: Number of Participants Who Experience One or More Adverse Events (AE)
timeFrame: Up to approximately 29 months
measure: Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
timeFrame: Up to approximately 29 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital ( Site 0140)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 0138)
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 0150)
state: Beijing
city: Chongqing
country: China
facility: First Affiliated Hospital of The Third Military Medical University ( Site 0130)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 0154)
state: Fujian
city: Fuzhou
country: China
facility: 900 Hospital of the Joint ( Site 0137)
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People s Hospital ( Site 0161)
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 0133)
state: Heilongjiang
city: Changsha
country: China
facility: Hunan Provincial People Hospital ( Site 0142)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 0132)
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University ( Site 0157)
state: Hunan
city: Nanjing
country: China
facility: The 81st Hospital of PLA ( Site 0128)
state: Jiangsu
city: Chanchun
country: China
facility: The First Hospital of Jilin University ( Site 0131)
state: Jilin
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University ( Site 0129)
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 0160)
state: Shanghai
city: XI An
country: China
facility: Tangdu Hospital ( Site 0146)
state: Shanxi
city: XI An
country: China
facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145)
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University ( Site 0147)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0155)
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University ( Site 0136)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 0134)
state: Zhejiang
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: