UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032600 |
|---|---|
| Receipt number | R000037172 |
| Scientific Title | EFFICACY AND SAFETY OF NIVOLUMAB IN RECURRENT OR METASTATIC HEAD AND NECK CANCER (HNC) PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW - |
| Date of disclosure of the study information | 2018/05/15 |
| Last modified on | 2023/08/16 11:02:20 |
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Basic information
Public title
EFFICACY AND SAFETY OF NIVOLUMAB IN RECURRENT OR METASTATIC HEAD AND NECK CANCER (HNC) PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW -
Acronym
- JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW -
Scientific Title
EFFICACY AND SAFETY OF NIVOLUMAB IN RECURRENT OR METASTATIC HEAD AND NECK CANCER (HNC) PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW -
Scientific Title:Acronym
- JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW -
Region
| Japan |
Condition
Condition
HEAD AND NECK CANCER
Classification by specialty
| Oto-rhino-laryngology | Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess overall effectiveness and safety of nivolumab in recurrent/metastatic head and neck cancer(HNC) patients with disease progression on or after a platinum-based therapy in a real-world clinical setting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Summary statistics for continuous outcomes will include mean, standard deviation, median,inter-quartile range, and range. Summary statistics for categorical or ordinal outcomes will include frequency and percentage. The primary analysis includes a description of actual usage of nivolumab and assessment of effectiveness
and safety in which pre-specified immune-related adverse events (irAEs) identified
Key secondary outcomes
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
Recurrent/metastatic HNC patients with disease progression on or after a platinum-based
therapy treated with nivolumab at least once from 01-Jul-2017 through 31-Dec-2017
Key exclusion criteria
History of participation in any clinical trials prior- or post-nivolumab treatment
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yamada |
Organization
Bristol-Myers Squibb
Division name
Japan Medical & Development, Oncology Medical
Zip code
100-0004
Address
1-21-1 Otemachi Otemachi One Tower, Chiyoda-ku, Tokyo
TEL
03-6705-7322
takayuki.yamada@bms.com
Public contact
Name of contact person
| 1st name | Jumpei |
| Middle name | |
| Last name | Kamimito |
Organization
Mebix, Inc
Division name
Oncology Group
Zip code
105-0001
Address
Toranomon, Minato-ku, Tokyo 3-8-21 Toranomon 33 Mori Building 10F
TEL
03-4362-4504
Homepage URL
headneck@mebix.co.jp
Sponsor or person
Institute
Bristol-Myers Squibb
Ono Pharmaceutical CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
Bristol-Myers Squibb
Ono Pharmaceutical CO.,LTD.
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
| 2018 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Not disclosed yet
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34773525/
Number of participants that the trial has enrolled
256
Results
Refer to the following articles
Int J Clin Oncol. 2021 Mar;26(3):494-506.
Int J Clin Oncol. 2021 Jun;26(6):1049-1056.
Int J Clin Oncol. 2022 Jan;27(1):95-104.
Results date posted
| 2023 | Year | 08 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Japanese patients with recurrent or metastatic HNC who received nivolumab for the first time between July and December 2017.
Participant flow
Data on the effectiveness and safety of nivolumab were extracted from patient medical records.
Adverse events
Refer to the following articles
Int J Clin Oncol. 2021 Mar;26(3):494-506.
Effectiveness and safety of nivolumab in patients with head and neck cancer in Japanese real-world clinical practice: a multicenter retrospective clinical study
Int J Clin Oncol. 2021 Jun;26(6):1049-1056.
Effectiveness of nivolumab affected by prior cetuximab use and neck dissection in Japanese patients with recurrent or metastatic head and neck cancer: results from a retrospective observational study in a real-world setting
Int J Clin Oncol. 2022 Jan;27(1):95-104.
Outcomes of long-term nivolumab and subsequent chemotherapy in Japanese patients with head and neck cancer: 2-year follow-up from a multicenter real-world study
Outcome measures
Primary Endpoints
Overall survival (continuous since nivolumab administration started)
Progression-free survival (continuous since nivolumab administration started)
Overall response rate and best overall response (RECIST 1.1)
Incidence rate of adverse events, treatment-related adverse events, and immune-rerated adverse events
Drug therapy treatment information (continuous since the time of head and neck cancer diagnosis)*
* Pharmacotherapy treatment information includes treatment before and after nivolumab administration and treatment including chemoradiation therapy
Secondary Endpoints
Effectiveness according to histology types, other subgroups of interest
Effectiveness and safety of treatment taken after nivolumab, including incidence and severity of adverse events
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational, retrospective medical chart review design that will be implemented with clinical data to be abstracted from patient medical records in Japan.
Management information
Registered date
| 2018 | Year | 05 | Month | 15 | Day |
Last modified on
| 2023 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037172
| Research Plan | |
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| Registered date | File name |
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