Clinical Trials Logo

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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Terminated NCT04003896 - A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma Phase 2
Active, not recruiting NCT04003636 - 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) Phase 3
Not yet recruiting NCT05064852 - A Real-world Study of the Safety and Efficacy of Surufatinib in the Treatment of Biliary Tract Carcinoma
Recruiting NCT05668884 - GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma Phase 2
Recruiting NCT05123482 - A Phase I/IIa Study of AZD8205 Given Alone or in Combination With Anticancer Drugs, in Participants With Advanced or Metastatic Solid Malignancies Phase 1/Phase 2
Active, not recruiting NCT02151084 - A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer Phase 2
Recruiting NCT06048133 - Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC) Phase 2
Recruiting NCT05845554 - Application of Chromosomal Instability in Early Diagnosis of Biliary Tract Carcinoma
Completed NCT00490399 - Trial of Gemcitabine and Cisplatin in Patients With Inoperable Biliary Tract Carcinomas Phase 2
Completed NCT04067960 - Pharmacogenomics Testing in Directing the Optimal Use of Supportive Care Medications in Patients With Stage III-IV Cancer Early Phase 1
Not yet recruiting NCT06430827 - Clinical Study of Irinotecan Hydrochloride Liposome Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma Phase 2
Withdrawn NCT02105350 - A Study of MEK162 With Gemcitabine and Oxaliplatin in Biliary Cancer Phase 1
Recruiting NCT06047990 - Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction N/A
Not yet recruiting NCT06463548 - Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma N/A
Terminated NCT04178460 - A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment Phase 1
Completed NCT03027284 - A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic Cancer Phase 1
Recruiting NCT06199882 - SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma Phase 2
Active, not recruiting NCT05023109 - GP Chemotherapy in Combination With Anti-PD-1 and Anti-TIGIT in Unresectable Advanced BTC Phase 2
Not yet recruiting NCT06168292 - Intraductal Radiofrequency Thermoablation and Radiotherapy Combined Treatment for Extrahepatic Cholangiocarcinoma N/A
Recruiting NCT04979663 - GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer Phase 1/Phase 2