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 | 2024/06/25 16:22:01 |
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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
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
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
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
https://link.springer.com/article/10.1007/s10147-024-02515-1 https://pubmed.ncbi.nlm.nih.gov/3884466
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10147-024-02515-1 https://pubmed.ncbi.nlm.nih.gov/3884466
Number of participants that the trial has enrolled
7421
Results
In 7421 patients with each cancer type who received nivolumab monotherapy, treatment related adverse event (TRAE) of all grades were observed in 49.1% and grade 3 or higher were observed in 16.7%. The frequency of rare TRAEs with a high risk of becoming serious was less than 1%. There was no marked increase in the frequency of TRAEs in special populations compared with the overall population.
Results date posted
| 2024 | Year | 06 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with melanoma, non-small cell lung cancer, renal cell carcinoma, head and neck cancer or gastric cancer treated with nivolumab monotherapy.
Participant flow
Participation in post-marketing surveillance in each cancer type.
Adverse events
-
Outcome measures
Frequency, incidence rate, and onset date of each treatment-related adverse event.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055680
