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
Verified date | March 2024 |
Source | Merck Sharp & Dohme LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme LLC |
China,
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 |
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