UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019674 |
|---|---|
| Receipt number | R000022733 |
| Scientific Title | An Open Label Phase II Biomarker Study of Nivolumab the anti-PD-1 antibody in Japanese Subjects with pretreated non-small cell lung cancer. |
| Date of disclosure of the study information | 2015/11/20 |
| Last modified on | 2021/05/11 09:34:06 |
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Basic information
Public title
An Open Label Phase II Biomarker Study of Nivolumab the anti-PD-1 antibody in Japanese Subjects with pretreated non-small cell lung cancer.
Acronym
Nivolution
Scientific Title
An Open Label Phase II Biomarker Study of Nivolumab the anti-PD-1 antibody in Japanese Subjects with pretreated non-small cell lung cancer.
Scientific Title:Acronym
Nivolution
Region
| Japan |
Condition
Condition
Pretreated Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the biomarker for efficacy of nivolumab for pretreated NSCLC patients.
Basic objectives2
Others
Basic objectives -Others
Evaluation of biomarker
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Evaluation of the relationship between the biomarker candidate and 6 months PFS rate.
Key secondary outcomes
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
biweekly 3mg/kg nivolumab treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically proven diagnosis of non-small cell lung cancer.
2)Disease recurrence or progression during/after one prior chemotherapy regimen (including EGFR-TKI and ALK-TKI) for advanced or metastatic disease
3)Able to collect blood samples and tumor tissues before treatment.
4)Men and women above 20 years of age
5)Eastern Cooperative Oncology Group (ECOG) performance status below 2
6)Evaluable disease, or measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
7)Adequate bone marrow function (hemoglobin above; 9.0 mg/dL; platelets above; 100 x 109/L; WBC above 2.0 X 109/L ANC above; 1.5 X 109/L without the use of hematopoietic growth factors)
8)Adequate renal function (creatinine below; 1.5 X ULN [upper limit of normal]).
9)Adequate hepatic function (total bilirubin below; 1.5 X ULN for the institution; AST [aspartate transaminase] and ALT [alanine transaminase] below; 3.0 X ULN).
10)Able to understand and give written informed consent and comply with study procedures.
Key exclusion criteria
Subjects with untreated symptomatic CNS metastases are excluded. 2 Symptomatic carcinomatous meningitis 3 Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism 4 Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization 5 Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 6 Subjects with interstitial lung disease 7 Treatment with any investigational agent within 14 days of first administration of study treatment 8 Known history of stroke or cerebrovascular accident within 6 months prior to the enrollment 9 Subjects with known infection with HIV or AIDS
10 Positive test for hepatitis B virus antigen or hepatitis C virus indicating acute or chronic infection 11 Any evidence of serious active infections. 12 Cancer directed therapy within 28 days of the first dose of nivolumab. 13 Major surgery within 28 days prior to the first dose of nivolumab.14 Uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to study treatment, NYHA Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis.15 Uncontrolled intercurrent illness including symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness social situations that would limit compliance with study requirements. 16 Subjects with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.17 Women who are pregnant or breast feeding.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Nakagawa |
Organization
Kindai University
Division name
Medical Oncology
Zip code
5898511
Address
Ohnohigashi 377-2, Osaka-sayama
TEL
072-366-0221
nakagawa@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Hayashi |
Organization
Kindai university, Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
5898511
Address
Ohnohigashi 377-2, Osaka-sayama
TEL
072-366-0221
Homepage URL
hidet31@med.kindai.ac.jp
Sponsor or person
Institute
Kindai university, Faculty of Medicine, Department of Medical Oncology
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University IRB
Address
377-2, Ohno-higashi
Tel
0723660221
zizen@med.kindai.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
52
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Delay of analysis
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 06 | Day |
Last modified on
| 2021 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022733
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