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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023838
Receipt No. R000027460
Scientific Title A phase II study evaluating abscopal effect of nivolumab in combination with local radiotherapy in patients with pretreated metastatic non-small cell lung cancer
Date of disclosure of the study information 2016/08/31
Last modified on 2018/09/03

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Basic information
Public title A phase II study evaluating abscopal effect of nivolumab in combination with local radiotherapy in patients with pretreated metastatic non-small cell lung cancer
Acronym A phase II study evaluating abscopal effect of nivolumab in combination with local radiotherapy in patients with pretreated metastatic non-small cell lung cancer
Scientific Title A phase II study evaluating abscopal effect of nivolumab in combination with local radiotherapy in patients with pretreated metastatic non-small cell lung cancer
Scientific Title:Acronym A phase II study evaluating abscopal effect of nivolumab in combination with local radiotherapy in patients with pretreated metastatic non-small cell lung cancer
Region
Japan

Condition
Condition Non-small cell Lung Cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate immune-mediated abscopal effect of nivolumab in combination with local radiotherapy
Basic objectives2 Others
Basic objectives -Others To evaluate safety and efficacy, and to explore the predictive biomarker of abscopal effect of nivolumab by blood samples.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate outside the radiation field
Key secondary outcomes toxicity, overall survival, progression free survival, survival time related to abscopal effect, disease control rate, abscopal response rate at 4/8 weeks after the complition of radiotherapy, immunological analysis using blood samples

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Nivolumab is given at 3 mg/kg intravenously every 2 weeks, and local radiotherapy is performed within 7 days after the previous administration of nivolumab. The timing of the blood sample collection is as follows; before and after radiotherapy, at the point of observing abscopal effect, and at disease progression.
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) Cytologically or histologically confirmed non-small cell lung cancer
(2) Stage IV or recurrent diseases without any indications for operation and radical radiotherapy
(3) At least one measurable lesions except lung field and suitable for palliative radiotherapy
(4) At least one measurable lesions except radiation site (RECIST ver1.1)
(5) Patients who have stable or progression disease (determined by at least two consecutive CT scans at 6-week intervals) after 8 weeks or more of nivolumab treatment
(6) Aged 20 or more
(7) ECOG Performance status of 0-2
(8) Adequate organ function within 2 weeks before study enrolment
(9) estimated life expectancy of at least 3 months
(10) Written informed consent
Key exclusion criteria (1) Active double cancer(except for some early or cured cancer as followe:carcino ma in situ, mucosal cancer, stage I prostate, breast, or laryngeal cancer)
(2) History of pericardial effusion, pleural effusion, and ascites which drainage treatment is needed
(3) patients with clinically disease progression, such as obvious PS deterioration by nivolumab administration
(4) radiation field includes the lung
(5) Positive serum HBs antigen
(6) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis
(7) Patients with a clinically severe complication
(8) History of severe drug allergy
(9) women who are or may be pregnant or in lactatoin
(10) patients judged to be unsuitable for this study by investigators
Target sample size 17

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Kumanogoh
Organization Osaka University Medical School
Division name Department of Respiratory, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine
Zip code
Address 2-2 Yamada-oka, Suita, Osaka
TEL +81-6-6879-3830
Email kumanogo@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Shiroyama
Organization Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Division name Department of Thoracic Malignancy
Zip code
Address 3-7-1 Habikino, Habikino City
TEL +81-72-957-2121
Homepage URL
Email takayuki.s12@hotmail.co.jp

Sponsor
Institute Department of Respiratory, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
Bristol-Myers Squibb.
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
Address
Tel
Email

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
2016 Year 08 Month 31 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 Terminated
Date of protocol fixation
2016 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 30 Day
Last modified on
2018 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027460

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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