UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048892
Receipt number R000055680
Scientific Title Integrated Analysis of Post Marketing Survey for Nivolumab
Date of disclosure of the study information 2022/09/09
Last modified on 2023/12/22 14:20:34

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Basic information

Public title

Integrated Analysis of Post Marketing Survey for Nivolumab

Acronym

Integrated Analysis of Post Marketing Survey for Nivolumab

Scientific Title

Integrated Analysis of Post Marketing Survey for Nivolumab

Scientific Title:Acronym

Integrated Analysis of Post Marketing Survey for Nivolumab

Region

Japan


Condition

Condition

Unresectable malignant melanoma
/Unresectable,advanced or recurrent Non-Small Cell Lung Cancer
/Unresectable or metastatic renal cell cancer
/Recurrent or distant metastatic head and neck cancer
/Unresectable advanced or recurrent gastric/gastroesophageal junction cancer that has progressed after chemotherapy

Classification by specialty

Gastroenterology Pneumology Hematology and clinical oncology
Gastrointestinal surgery Chest surgery Dermatology
Oto-rhino-laryngology Urology Oral surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the safety profile(incidence of adverse events, time of onset, exacerbation/relapse/risk factors of complications/past diseases, etc. of nivolumab monotherapy in patients with various complications/histories (Autoimmune disease, tuberculosis, hepatitis B, hepatitis C), elderly patients, or patients with a history of vaccination.To characterize risk factors for the development of irAEs with a high risk of becoming serious.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety profile of Nivolumab in patients with various complications/past history (autoimmune disease, tuberculosis, hepatitis B, hepatitis C), elderly patients, and vaccinated patients (incidence of adverse events, incidence of special interest, time of onset, etc.)Risk factors for the development of irAEs with a high risk of becoming serious

Key secondary outcomes

Safety profile in the overall population"incidence of adverse events,incidence of adverse event of special interest,time of onset, etc."/Risk factors for recurrence/aggravation of various complications/past histories"autoimmune disease,tuberculosis,hepatitisB,hepatitis C"Safety profile in each autoimmune disease"number of events,number of events of Grade3 or more and outcome"


Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

In the post marketing survey of nivolumab for each of the following cancer types, patients who met the criteria for safety analysis among the population in which fixed CRFs were collected.
/Unresectable malignant melanoma
/Unresectable,advanced or recurrent NSCLC
/Unresectable or metastatic renal cell cancer
/Recurrent or distant metastatic head and neck cancer
/Unresectable advanced or recurrent gastric/gastroesophageal
junction cancer that has progressed after chemotherapy


Key exclusion criteria

Of the patients who met the criteria for the safety analysis set, those for whom the site approval was not obtained for the use of PMS data.

Target sample size

7421


Research contact person

Name of lead principal investigator

1st name Hiroki
Middle name
Last name Matsumoto

Organization

Ono Pharmaceutical Co., Ltd.

Division name

Oncology Medical , Medical Affairs

Zip code

541-8564

Address

8-2,Kyuutaromachi 1-chome, Chuo-ku osaka-shi, Osaka

TEL

06-6263-2992

Email

hi.matsumoto@ono.co.jp


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Hiraizumi

Organization

Ono Pharmaceutical Co., Ltd.

Division name

Oncology Medical , Medical Affairs

Zip code

541-8564

Address

8-2,Kyuutaromachi 1-chome, Chuo-ku osaka-shi, Osaka

TEL

06-6263-2992

Homepage URL


Email

hiraizumi@ono.co.jp


Sponsor or person

Institute

Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb K.K.

Institute

Department

Personal name



Funding Source

Organization

Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb K.K.

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

Ono Pharmaceutical CO.,LTD. "Medical and Health Research Involving Human Subjects" Ethics Committee

Address

8-2,Kyuutaromachi1-chome,Chuo-ku, osaka-shi,Osaka

Tel

06-6263-2992

Email

n.nishiwaki@ono.co.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

2022 Year 09 Month 09 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

2022 Year 07 Month 01 Day

Date of IRB

2022 Year 07 Month 01 Day

Anticipated trial start date

2022 Year 10 Month 01 Day

Last follow-up date

2024 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2022 Year 09 Month 09 Day

Last modified on

2023 Year 12 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055680


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name