Phase 3
N=1,069
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)
Biliary Tract Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04003636 ↗Enrolled (actual)
1,069
Serious AEs
50.7%
Results posted
Dec 2023
Primary outcome: Primary: Overall Survival (OS) — 12.7; 10.9 Months — p=0.0034
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pembrolizumab (Biological); Gemcitabine (Drug); Cisplatin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
12.7; 10.9 | 0.0034 sig |
| SECONDARY Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR) |
6.5; 5.6 | 0.0225 sig |
| 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) |
28.7; 28.5 | 0.4735 |
| SECONDARY Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR |
8.3; 6.8 | — |
| SECONDARY Number of Participants Who Experience One or More Adverse Events (AE) |
524; 532 | — |
| SECONDARY Number of Participants Who Discontinued Study Intervention Due to an AE |
140; 125 | — |
Summary
This is a 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. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04003636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.