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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032600
Receipt No. 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 2018/12/20

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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
Middle name
Last name Takayuki Yamada
Organization Bristol-Myers Squibb
Division name Japan Medical & Development, Oncology Medical
Zip code
Address 6-5-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo 163-1327
TEL 03-6705-7322
Email takayuki.yamada@bms.com

Public contact
Name of contact person
1st name
Middle name
Last name Jumpei Kamimito
Organization Mebix, Inc
Division name Oncology Group
Zip code
Address Toranomon, Minato-ku, Tokyo 3-8-21 Toranomon 33 Mori Building 10F
TEL 03-4362-4504
Homepage URL
Email headneck@mebix.co.jp

Sponsor
Institute Bristol-Myers Squibb
Ono Pharmaceutical CO.,LTD.
Institute
Department

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
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
2018 Year 05 Month 15 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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 08 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 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
2018 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037172

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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