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

Biliary Tract Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04924062
• Other study ID #: 3475-966 China Extension
• Secondary ID: MK-3475-966KEYNO
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 10, 2020
• Est. completion date: November 29, 2024

Study information

• Verified date: March 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 158
• Est. completion date: November 29, 2024
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Carcinoma
• Carcinoma

Intervention

Biological:
• Pembrolizumab
Pembrolizumab by intravenous (IV) infusion

Drug:
• Gemcitabine
Gemcitabine by IV infusion
• Cisplatin
Cisplatin by IV infusion
• Placebo
Placebo to pembrolizumab

Locations

Country	Name	City	State
China	Beijing Cancer Hospital ( Site 0138)	Beijing	Beijing
China	Peking Union Medical College Hospital ( Site 0150)	Beijing	Beijing
China	The First Hospital of Jilin University ( Site 0131)	Chanchun	Jilin
China	Hunan Cancer Hospital ( Site 0132)	Changsha	Hunan
China	Hunan Provincial People Hospital ( Site 0142)	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University ( Site 0157)	Changsha	Hunan
China	West China Hospital of Sichuan University ( Site 0147)	Chengdu	Sichuan
China	First Affiliated Hospital of The Third Military Medical University ( Site 0130)	Chongqing	Chongqing
China	900 Hospital of the Joint ( Site 0137)	Fuzhou	Fujian
China	Fujian Provincial Cancer Hospital ( Site 0154)	Fuzhou	Fujian
China	Guangdong Provincial People s Hospital ( Site 0161)	Guangzhou	Guangdong
China	The First Affiliated Hospital Zhejiang University ( Site 0136)	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital ( Site 0134)	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital ( Site 0133)	Harbin	Heilongjiang
China	Anhui Provincial Hospital ( Site 0140)	Hefei	Anhui
China	The 81st Hospital of PLA ( Site 0128)	Nanjing	Jiangsu
China	Fudan University Shanghai Cancer Center ( Site 0160)	Shanghai	Shanghai
China	Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University ( Site 0129)	Shanghai	Shanghai
China	Tianjin Medical University Cancer Institute & Hospital ( Site 0155)	Tianjin	Tianjin
China	Tangdu Hospital ( Site 0146)	XI An	Shanxi
China	The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145)	XI An	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 29 months
Secondary	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.	Up to approximately 29 months
Secondary	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.	Up to approximately 29 months
Secondary	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.	Up to approximately 29 months
Secondary	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.	Up to approximately 29 months
Secondary	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.	Up to approximately 29 months

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary