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

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 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


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

Value
https://center6.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