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Biliary Tract CancerPhase 2/3NCT05429697

Study of SMT-NK Inj. Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer

A Phase 2/3 study testing SMT-NK inj.+Pembrolizumab and Pembrolizumab in people with Biliary Tract Cancer, run by SMT bio Co., Ltd. at 3 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Biliary Tract Cancer
What is being tested?
SMT-NK inj.+Pembrolizumab and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
3 sitesSouth Korea
Study dates
9 Jun 2022to 8 Jun 2026
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who received a histopathological or cytologic diagnosis of nonresectable, advanced biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer) and patients with refractory disease after chemotherapy and/or patients who have difficulty with chemotherapy due to side effects of chemotherapy.
  • Patients who receives an explanation from the trial manager about the purpose, contents, and characteristics of the Investigational products for the clinical trial and is signed by the person, guardian or legal representative in the written informed consent.
  • 19 to 80 years old on day of signing informed consent.
  • Histopathological or cytologic diagnosis of advanced adenocarcinoma of the biliary tract and those with measurable lesions for RECIST evaluation
  • Tumor lesion: Must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of 10mm by CT scan
  • Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node must be ≥15mm in short axis when assessed by CT scan
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  • Have a performance status of ≤2 on the ECOG Performance Scale.
  • Patients who survival period is expected to be at least 3 months.
  • Demonstrate laboratory test results the following conditions:
  • ANC (Absolute Neutrophil Count) ≥ 1,500/μL
  • Hemoglobin≥ 9 g/dL
  • Platelet> 80,000/μL
  • serum BUN \& Creatinine ≤ 2.0 x upper limit of normal (ULN)
  • AST \& ALT ≤ 5.0 x upper limit of normal (ULN)
  • Bilirubin ≤ 5mg/dL
  • Albumin ≥ 2.8g/dL
  • Prothrombin time (PT)% activity ≥ 70%
  • Patients or partners who has agreed to the appropriate use of contraceptives by two or more during the treatment period (including Survival follow-up period) (for men, those who have agreed not to provide sperm)
  • Patients who meet one or more of the following conditions:
  • 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.
  • CPS = (number of PD-L1 positive tumor cells, lymphocytes, macrophage)/ (total number of viable tumor cells) X 100
  • Immunohistochemistry: IHC 22C3 pharmDx test
  • ② Patients who have a positive MSI-H or dMMR test
  • MSI-high positive tumors analyzed by PCR
  • dMMR positive tumors analyzed by immunohistochemical staining
  • MSI-H was measured by PCR, and positive finding when two or more unstable markers were detected in PCR for 5 microsatellite markers, **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.

Who cannot join

  • Patients who have previous history
  • Immune deficiency or autoimmune disease that can be aggravated by immunotherapy (for example: Rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, Crohn's disease, ulcerative colitis, adolescent-developed insulin-dependent diabetes mellitus).
  • Immune deficiency disease
  • Pneumonia, colitis, hepatitis, nephritis, endocrine diseases associated with immunodeficiency (hypophysis, thyroid dysfunction, Type 1 diabetes, etc.)
  • Obvious myocardial failure or uncontrolled arterial hypertension
  • Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
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  • Non-infectious pneumonia, interstitial lung disease
  • Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid (RNA) [qualitative] is detected) infection or active tuberculosis
  • Active infection (if systemic treatment is required)
  • Has a diagnosed and/or treated additional malignancy within 5 years prior to signing informed consent except for curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin
  • Has a previous history of anti-angiogenic agent treatment before signing informed consent
  • Has a known serious allergic history
  • Has a known serious mental illness
  • Identified the following in Screening:
  • CRP ≥10 mg/dl and albumin ≤3.0 g/dl are suspected of cancer cachexia
  • Patients who have symptomatic ascites that is not controlled by medical treatment
  • Has received chemotherapy not less than 4 weeks old before randomization
  • Has received a live vaccine within 4 weeks before randomization
  • Is currently participating in or has participated in another clinical study within 4 weeks before randomization or the adverse event due to investigational drug administered remain before randomization
  • Has previously administrated Pembrolizumab and another anti-PD-1/PD-L1 agent
  • Has previously administrated immune-cell therapy (including natural killer cell etc.)
  • Female who are pregnant, breastfeeding or intending to become pregnant during the study period.
  • Has a history of any contraindication or has a severe hypersensitivity to any components of pembrolizumab
  • Has performed major surgery within 4 weeks prior to signing informed consent
  • Patients who are unsuitable to participate in clinical trials by investigator's decision

Trial locations and contacts

3 sites in 1 country.

JUNGMIN IM contact

82-02-6297-0515

jungminim@smtbio.co.kr

HAEJIN IM contact

82-02-6297-0515

imjin@smtbio.co.kr

South Korea3 sites, 3 recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

    SANGMYUNG WOO, 82-31-920-1733, wsm@ncc.re.kr

    Recruiting

  • Severance Hospital

    Seoul, 03722

    Seung Woo Park, MD. PhD, 82-2-2228-1964, SWOOPARK@yuhs.ac

    Recruiting

  • Gangnam Severance Hospital

    Seoul, 06273

    Sung Ill Jang, MD. PhD, 82-2-2019-3580, AEROJSI@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

Official title: Randomized, Placebo-controlled, Open-label, Phase 2b Clinical Trial to Evaluate the Antitumor Activity of Combination Therapy of SMT-NK and Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer

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

Read the detailed description

The term of biliary tract cancer (BTC) refers to all tumors that arise from the biliary tract or the biliary drainage system, including the gallbladder.Biliary tract cancer is one of the most poorly prognosis cancers and the five-year survival rate remains at about 10% as it is difficult to expect long-term survival due to frequent local recurrence and remote metastasis after surgery.

South Korea belongs to a country with a high number of biliary tract cancer patients, and the incidence of biliary tract cancer is actually increasing every year.According to the 2018 National Cancer Registration Statistics, the number of 5-year biliary tract cancer patients was 13,967 (7,547 men and 6,420 women), which corresponds to about 2.9% of all cancersand the 5-year survival rate of biliary tract cancer patients between 2014 and 2018 was 28.8%, showing a lower survival rate than other cancer species.

Most of the long-term survival is due to early detection by screening, but advanced carcinoma is a refractory carcinoma with a 5-year survival rate of less than 5%.In addition to standard anticancer drugs, alternative anticancer drugs and targeted treatments can be developed for cancer with a large number of patients, but biliary tract cancer is difficult to find any more treatments if standard treatment fails and standard anticancer treatments cannot be continued due to resistance.

Natural killer cells (NK cells) are innate lymphocyte cells with cell killing activity, and have the characteristic of destroying cells by secretion of and granzyme into cancer cells and abnormal cells that are reduced or deficient in expression of MHC class I.Clinical studies using natural killer cells as anticancer drugs have long been conducted on various cancers.

Pembrolizumab is a monoclonal antibody designed to bind to a receptor called PD-1, which is expressed by immune cells such as T cells.Natural killer cells were also found to be expressing PD-1 in the same way as T cells, and in particular, PD-1 was found to be higher in cancer patients than in healthy people.

Therefore, combined therapy with the immune-check point such as pembrolizumab can be useful in elevating the anticancer activity of NK cells.

Being tested
SMT-NK inj.+Pembrolizumab, Pembrolizumab
Keywords
BTC, Cholangiocarcinoma, Biliary tract cancer
Medical subject headings
Biliary Tract Neoplasms, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SMT-NK inj.+PembrolizumabDrug

    SMT-NK inj. will be administered as an intravenous (IV) infusion on Day 1,Day 7 of each 21-day cycle.

    Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

  • PembrolizumabDrug

    Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

Study groups in NCT05429697
Study groupRoleWhat they receive
Pembrolizumab+SMT-NK inj.ExperimentalExperimental: Pembrolizumab + SMT-NK inj. Participants will be randomized to receive 200 mg pembrolizumab followed by 3*10^6cells/kg SMT-NK inj. Interventions: Drug: SMT-NK inj. Drug: Pembrolizumab
Receives: Drug: SMT-NK inj.+Pembrolizumab
PembrolizumabPlacebo comparatorPlacebo Comparator: Pembrolizumb Participants will be randomized to receive 200 mg pembrolizumab. Intervention: Drug: Pembrolizumab
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Progression-free survival (PFS) is defined as the time from the date of initial administration of the clinical trial drug to the progression or death due to any cause of the disease

    Measured: Up to approximately 72 weeks from the date of first administration of clinical trial drugs

Secondary outcomes (8)

  1. Object Response rate

    Objective response rate (ORR) is defined as the ratio of subjects whose best overall response (hereinafter referred to as BOR) is partial response (PR) or complete response (CR) assessed by RECIST Version 1.1 and iRECIST.

    Measured: Up to approximately 72 weeks from the date of first administration of clinical trial drugs

  2. Time to Progression

    Time to disease progression (TTP) is defined as the time from the first administration date of the clinical trial drug to the first disease progression

    Measured: Up to approximately 72 weeks from the date of first administration of clinical trial drugs

  3. Overall Survival

    Overall survival(OS) is defined as the time from the date of first administration of the clinical trial drug to the death of all causes

    Measured: Up to approximately 120 weeks from the date of first administration of clinical trial drugs

  4. Duration of Response

    Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first disease progression or death due to any cause.

    Measured: Up to approximately 72 weeks from the date of first administration of clinical trial drugs

  5. Disease Control Rate

    Disease Control Rate (DCR) is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD), assessed by RECIST Version 1.1 and iRECIST

    Measured: Up to approximately 72 weeks from the date of first administration of clinical trial drugs

  6. Best Overall Response

    In order for the best overall response (BOR) to be finally evaluated as partial response (PR) or complete response (CR), it must be evaluated as partial response (PR) or complete response (CR) in two consecutive evaluations by RECIST Version 1.1 and iRECIST.

    Measured: Up to approximately 72 weeks from the date of first administration of clinical trial drugs

  7. Time to Response

    The time to response (TTR) is defined as the time from the date of first administration of the clinical trial drug to the time when it is evaluated as the first partial response (PR) or full response (CR) by RECIST Version 1.1 and iRECIST.

    Measured: Up to approximately 72 weeks from the date of first administration of clinical trial drugs

  8. Quality of Life

    Assessed by EORTC-QLQ(The European Organization for Research and Treatment-QoL questionnaire) C30

    Measured: Up to approximately 72 weeks from the date of first administration of clinical trial drugs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2022
  2. Study start9 Jun 2022
  3. Primary completion8 Jan 2025 (estimated)
  4. Study completion8 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05429697
Sponsor's protocol ID
SNK-SIT-03
Status last verified
Jun 2022
First submitted
17 Jun 2022
Last updated
27 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SMT-NK inj.+Pembrolizumab and Pembrolizumab in people with Biliary Tract Cancer, run by SMT bio Co., Ltd. at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact JUNGMIN IM (82-02-6297-0515, jungminim@smtbio.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: Up to approximately 72 weeks from the date of first administration of clinical trial drugs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05429697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.

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