UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023838 |
|---|---|
| Receipt number | 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 08:35:29 |
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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
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
takayuki.s12@hotmail.co.jp
Sponsor or person
Institute
Department of Respiratory, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027460
