UMIN-CTR Clinical Trial

Basic information
Public title	Multi-institutional investigation: Biomarker identification for proper use of Nivolmab for head and neck cancer.
Acronym	Multi-institutional investigation: Biomarker identification for proper use of Nivolmab for head and neck cancer.
Scientific Title	Multi-institutional investigation: Biomarker identification for proper use of Nivolmab for head and neck cancer.
Scientific Title:Acronym	Multi-institutional investigation: Biomarker identification for proper use of Nivolmab for head and neck cancer.
Region	Japan

Condition
Condition	head and neck cancer
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Identification of a new biomarker of Nivolmab for head and neck cancer, by investigating the treatment response and analyzing gene mutation, gene mutation frequency and tumor microenvironment
Basic objectives2	Others
Basic objectives -Others	Exploratory observational study to proper use of Nivolmab
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification of a new biomarker of Nivolmab for head and neck cancer.
Key secondary outcomes

Base
Study type	Observational

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient with recurrent or metastatic head and neck cancer who recieved Nivolmab
Key exclusion criteria	Patient without the history of treatment of the chemotherapy including the platinum Patient who received Nivolmab as adjuvant chemotherapy The patient who received a combination with other anti-cancer agents
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Asakage
Organization	Tokyo Medical and Dental University
Division name	Department of Head and Neck Surgery
Zip code	113-8519
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5913
Email	tasakage@gmail.com

Public contact
Name of contact person	1st name Kazuchika Middle name Last name Ohno
Organization	Tokyo Medical and Dental University
Division name	Department of Head and Neck Surgery
Zip code	113-8519
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5913
Homepage URL
Email	ohno.hns@tmd.ac.jp

Sponsor
Institute	Department of Head and Neck Surgery, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	ONO PHARMACEUTICAL CO., LTD. Bristol-Myers Squibb Company
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	IRB of Tokyo Medical and Dental University
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel	03-5803-5096
Email	rec.adm@tmd.ac.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	2019 Year 06 Month 05 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	2018 Year 08 Month 27 Day
Date of IRB	2018 Year 08 Month 27 Day
Anticipated trial start date	2018 Year 08 Month 27 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Identification of a new biomarker of Nivolmab for head and neck cancer, by investigating the treatment response and analyzing gene mutation, gene mutation frequency and tumor microenviroment.

Management information
Registered date	2019 Year 06 Month 05 Day
Last modified on	2020 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042124