Biliary Tract Carcinoma
Conditions
Interventions
investigational material(s)
Generic name etc :
INN of investigational material : pembrolizumab gemcitabine cisplatin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration f
Sponsors
MSD K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer). 2. Has measurable disease based on RECIST 1.1, as determined by the site investigator. 3. Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria. 4. Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion. 5. Have a life expectancy of greater than 3 months. 6. Have adequate organ function.
Exclusion criteria
Exclusion criteria: 1. Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer), with the exception of neoadjuvant/adjuvant therapy which is allowed. 2. Has ampullary cancer. 3. Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms. 4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137). 5. Has a known history of, or any evidence of, CNS metastases and/or carcinomatous meningitis, as assessed by local site investigator. 6. Has had an allogenic tissue/solid organ transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Objective: To compare overall survival (OS) between pembrolizumab plus gemcitabine/cisplatin and placebo plus gemcitabine/cisplatin OS: the time from randomization to death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Objective: To compare progression-free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR) between pembrolizumab plus gemcitabine/cisplatin and placebo plus gemcitabine/cisplatin PFS: the time from randomization to the first documented PD per RECIST 1.1 by BICR, or death due to any cause, whichever occurs first Objective: To compare objective response rate (ORR) per RECIST 1.1 as assessed by BICR between pembrolizumab plus gemcitabine/cisplatin and placebo plus gemcitabine/cisplatin Objective Response (OR): complete response (CR) or partial response (PR) Objective: To evaluate duration of response (DOR) per RECIST 1.1 as assessed by BICR DOR: for participants who demonstrate confirmed CR or PR, the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first Objective: To evaluate the safety and tolerability profile (AEs, Study intervention discontinuations due to AEs) of pembrolizumab plus gemcitabine/cisplatin | — |
Countries
Asia except Japan, Japan, North America
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed