UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023276 |
|---|---|
| Receipt number | R000026649 |
| Scientific Title | Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3) as immunotherapy for patients with recurrent/metastatic lung cancer |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2023/07/02 15:38:25 |
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Basic information
Public title
Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3) as immunotherapy for patients with recurrent/metastatic lung cancer
Acronym
Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3)
Scientific Title
Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3) as immunotherapy for patients with recurrent/metastatic lung cancer
Scientific Title:Acronym
Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3)
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate safety on immunotherapy using CpG-ODN(K3) in patient with lung cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Assessment of safety
Key secondary outcomes
Progression-free survival
Assessment of specific immune response
Adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CpG-ODN(K3)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically proven lung cancer
2) Non-small cell lung cancer: Clinical stage III, IV, or postoperative recurrence
Small cell lung cancer: Clinical stage II, III, IV
3) Age from 20 to 79 years
4) ECOG performance status of 0 or 1
5) Previously treated, one platinum doublet regimen
6) Response criteria of platinum doublet chemotherapy achieved more than and equal to SD
A mesurable lesion is not required
7) Within 4 months after start of last cycle of platinum doublet chemotherapy
8) Recover from hematological toxicity
9) Adequate function of major organs
10) Written informed consent
Key exclusion criteria
1) Synchronous or metachronous malignancies
2) Symptomatic brain metastasis
3) Massive pleural effusion required for tube drainage
4) Infectious disease requiring systemic treatment
5) Positive test for hepatitis B virus antigen or hepatitis C virus or human immunodeficiency virus
6) History of unstable angina or myocardial infarction
7) Interstitial pneumonia on chest CT
8) History of antiphospholipid antibody syndrome
9) Subjects with active, known or suspected autoimmune disease
10) Current use of aspirin, or anticlotting drug or thrombolytic agent
11) Receiving continuous systemic corticosteroid treatment
12) Pregnant status or lactation
13) Severe psychological disorder
14) Other ineligible status judged by medical oncologist
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Sumiyuki |
| Middle name | |
| Last name | Nishida |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Respiratory Medicine and Clinical Immunology
Zip code
565-0871
Address
2-2,Yamada-oka,Suita,Osaka, Japan
TEL
06-6879-3831
sumiyuki-n@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Sumiyuki |
| Middle name | |
| Last name | Nishida |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Respiratory Medicine and Clinical Immunology
Zip code
565-0871
Address
2-2,Yamada-oka,Suita,Osaka, Japan
TEL
06-6879-3831
Homepage URL
http://www.imed3.med.osaka-u.ac.jp/c-research/cr-resp11.html
sumiyuki-n@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institutes of Biomedical Innovation,Health and Nutrition
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Medical Innovation, Osaka University Hospital
Address
2-2,Yamada-oka,Suita,Osaka, Japan
Tel
06-6210-8289
kida@dmi.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35799134/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35799134/
Number of participants that the trial has enrolled
9
Results
No DLTs at any dose level.
No serious treatment-related adverse events.
Serum IFN-a2 levels increased in six patients after the third administration of CpG ODN (K3). Serum IFN-g and CXCL10 levels increased in eight patients after the third administration. The percentage of T-bet-expressing CD8+ T cells increased. Both T-bet-expressing effector memory (p = 0.0195) and terminally differentiated effector memory (p = 0.0039) CD8+ T cells significantly increased.
The median PFS was 398 days.
Results date posted
| 2023 | Year | 07 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
eight non-small-cell lung cancer; one small-cell lung cancer
Participant flow
CpG ODN (K3) was injected via subcutaneous or intravenous administration on days 1, 8, 15, and 29 (study treatment phase) and then every 4-6 weeks until a maximum of 6 months (compassionate use phase).
Adverse events
In total, 27 systemic adverse events were reported, of which 16 (59.3%) were determined to be treatment-related adverse events(TrAEs). All adverse events were of grade 1 or 2.
Outcome measures
The primary endpoint was the proportion of dose-limiting toxicities at each dose level. Secondary endpoints included safety profile, an immune response, including dynamic changes in immune cell and cytokine production, and progression-free survival.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026649
