OncoMatch/Clinical Trials/NCT05429697
Study of SMT-NK Inj. Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer
Is NCT05429697 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including SMT-NK inj.+Pembrolizumab and Pembrolizumab for biliary tract cancer.
Treatment: SMT-NK inj.+Pembrolizumab · Pembrolizumab — This study is designed to assess the antitumor activity of combination therapy of SMT-NK (allogeneic natural killer cells) and pembrolizumab versus pembrolizumab monotherapy in patients with advanced biliary tract cancer
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Biomarker criteria
Required: PD-L1 (CD274) Combined Positive Score (CPS) PD-L1 expression ≥ 1% (CPS ≥ 1%)
Patients have at least 1% Combined Positive Score (*CPS) PD-L1 expression detected on the tumor, as determined by **immunohistochemistry performed by a central laboratory.
Required: MLH1 loss
dMMR is analyzed by immunohistochemical staining and positive when the discovery of one or more genes in MLH1, MSH2, MSH6 and PMS2 staining is lost.
Required: MSH2 loss
dMMR is analyzed by immunohistochemical staining and positive when the discovery of one or more genes in MLH1, MSH2, MSH6 and PMS2 staining is lost.
Required: MSH6 loss
dMMR is analyzed by immunohistochemical staining and positive when the discovery of one or more genes in MLH1, MSH2, MSH6 and PMS2 staining is lost.
Required: PMS2 loss
dMMR is analyzed by immunohistochemical staining and positive when the discovery of one or more genes in MLH1, MSH2, MSH6 and PMS2 staining is lost.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy
patients with refractory disease after chemotherapy and/or patients who have difficulty with chemotherapy due to side effects of chemotherapy
Cannot have received: anti-angiogenic agent
Has a previous history of anti-angiogenic agent treatment before signing informed consent
Cannot have received: anti-PD-1/PD-L1 agent (pembrolizumab)
Has previously administrated Pembrolizumab and another anti-PD-1/PD-L1 agent
Cannot have received: immune-cell therapy
Has previously administrated immune-cell therapy (including natural killer cell etc.)
Lab requirements
Blood counts
anc ≥ 1,500/μl; hemoglobin ≥ 9 g/dl; platelet > 80,000/μl
Kidney function
serum bun & creatinine ≤ 2.0 x uln
Liver function
ast & alt ≤ 5.0 x uln; bilirubin ≤ 5mg/dl; albumin ≥ 2.8g/dl; prothrombin time (pt)% activity ≥ 70%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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