Actively Recruiting
Study of SMT-NK Inj. Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer
Led by SMT bio Co., Ltd. · Updated on 2022-09-27
128
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study of SMT-NK Inj. Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with nonresectable, advanced biliary tract carcinoma confirmed by tissue or cell diagnosis
- Patients who have received chemotherapy previously but have refractory disease or cannot continue due to side effects
- Age between 19 and 80 years at consent
- Histopathological or cytologic diagnosis of advanced biliary tract adenocarcinoma with measurable lesions by CT scan
- Performance status of 0, 1, or 2 on the ECOG scale
- Expected survival of at least 3 months
- Laboratory results meeting specified blood counts and organ function limits
- Agreement to use appropriate contraception during treatment and follow-up
- Tumors with at least 1% PD-L1 expression or positive MSI-H or dMMR test results
You will not qualify if you...
- Immune deficiency or autoimmune disease that may worsen with immunotherapy
- Pneumonia, colitis, hepatitis, nephritis, or endocrine diseases linked to immunodeficiency
- Severe heart failure or uncontrolled high blood pressure
- Active brain metastases or carcinomatous meningitis
- Non-infectious pneumonia or interstitial lung disease
- HIV infection or active hepatitis B/C or tuberculosis
- Active infections requiring systemic treatment
- Additional cancers diagnosed or treated within 5 years except certain skin cancers
- Previous anti-angiogenic agent treatment
- Serious allergic history or mental illness
- Signs of cancer cachexia or uncontrolled ascites
- Chemotherapy within 4 weeks before randomization
- Live vaccine within 4 weeks before randomization
- Participation in another clinical trial within 4 weeks before randomization
- Previous treatment with pembrolizumab or other anti-PD-1/PD-L1 agents
- Previous immune-cell therapy including natural killer cells
- Pregnant or breastfeeding women
- Severe allergy to pembrolizumab components
- Major surgery within 4 weeks prior to consent
- Investigator deems patient unsuitable for trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 10408
Actively Recruiting
2
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
3
Gangnam Severance Hospital
Seoul, South Korea, 06273
Actively Recruiting
Research Team
J
JUNGMIN IM
CONTACT
H
HAEJIN IM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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