Pembrolizumab or Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable BTC

JRCT ID: jRCT2080224922

Registered date:17/10/2019

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Biliary Tract Carcinoma
• Date of first enrollment: 15/11/2019
• Target sample size: 1048
• Countries of recruitment: Japan,Asia except Japan,North America
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc :
INN of investigational material : pembrolizumab gemcitabine cisplatin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material :

control material(s)
Generic name etc :
INN of investigational material : - gemcitabine cisplatin
Therapeutic category code : --- Other
Dosage and Administration for Investigational material :

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: MSD K.K.
• Secondary ID(s): NCT04003636,JapicCTI-195007