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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019674
Receipt No. 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 2019/05/09

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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
Last 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
Email nakagawa@med.kindai.ac.jp

Public contact
1st 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
Email hidet31@med.kindai.ac.jp

Sponsor
Institute Kindai university, Faculty of Medicine, Department of Medical Oncology
Institute
Department

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
Email 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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
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
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
2019 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022733

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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