UMIN-CTR Clinical Trial

Basic information
Public title	Identification of biomarkers which reflects the treatments effects of Nivolmab through comprehensive analyses of serum exosmal mRNA derived from the HNSCC patients.
Acronym	BIO-NEXT study
Scientific Title	Identification of biomarkers which reflects the treatments effects of Nivolmab through comprehensive analyses of serum exosmal mRNA derived from the HNSCC patients.
Scientific Title:Acronym	Identification of biomarkers which reflects the treatments effects of Nivolmab through comprehensive analyses of serum exosmal mRNA derived from the HNSCC patients.
Region	Japan

Condition
Condition	head and neck squamous cell cancer
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study identifies the biomarker which predict curative effect of nivolumab by inspecting the expression of the tumor derived exosomes (TEX) mRNA .
Basic objectives2	Others
Basic objectives -Others	Identification of biomarkers
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Response rate
Key secondary outcomes	1-year survival rate

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	1.Patients who are eligible for nivolumab for head and neck cancer cases with recurrence or distant metastasis. Primary site: nasal sinus, oral cavity, nasopharynx, oropharynx (p16 positive), oropharynx (p16 negative), hypopharynx, larynx (upper glottic, lower glottic) 2.Patients who are diagnosed histologically as squamous cell carcinoma. 3.Patients aged 20 and over at the time of signing the Informed Consent Form. 4.Patients with target lesion by RECIST on imaging examination within 28 days before enrollment. As basics,it is a contrast CT examination. However, if contrast-enhanced CT examination is impossible or inappropriate due to contrast agent allergy, renal dysfunction, or problems in image evaluation, simple CT, contrast-enhanced MRI, or simple MRI can be substituted. 5.Patients who fully understand this research plan and have obtained written consent.
Key exclusion criteria	1.Patients who have been given immune checkpoint inhibitors in the past. 2.Patients with ECOG Performance Status 3 or 4 3.Patients under tumor immunotherapy or with plan to be co-administered with other antineoplastic agents. 4.Patients with active double cancer excluding CIS and endoscopically treatable early esophagus cancer. 5.patients judged inappropriate by investigators.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Muneyuki Middle name Last name Masuda
Organization	National Hospital Organization Kyushu Cancer Center
Division name	Department of Head and Neck Surgery
Zip code	811-1395
Address	3-1-1 Minami-ku, Fukuoka 811-1395, Japan
TEL	092-541-3231
Email	mmuneyuki@icloud.com

Public contact
Name of contact person	1st name Satoshi Middle name Last name Toh
Organization	National Hospital Organization Kyushu Cancer Center
Division name	Department of Head and Neck Surgery
Zip code	811-1395
Address	3-1-1 Minami-ku, Fukuoka 811-1395, Japan
TEL	092-541-3231
Homepage URL
Email	toh.satoshi.th@mail.hosp.go.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

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	National Hospital organization Kyushu Cancer Center Ethics Committee
Address	3-1-1 Minami-ku, Fukuoka 811-1395, Japan
Tel	092-541-3231
Email	601-rinri@mail.hosp.go.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

北海道大学病院（北海道）、恵佑会札幌病院（北海道）、宮城県立がんセンター（宮城県）、東京医科歯科大学医学部附属病院（東京都）、慶應義塾大学病院（東京都）、東京医科大学（東京都）、横浜市立大学（神奈川県）、静岡県立静岡がんセンター（静岡県）、新潟大学医歯学総合病院（新潟県）、名古屋大学医学部附属病院（愛知県）、愛知県がんセンター（愛知県）、京都大学医学部附属病院（京都府）、大阪大学医学部附属病院（大阪府）、関西医科大学附属病院（大阪府）、大阪府立病院機構大阪国際がんセンター（大阪府）、神戸大学大学院医学研究科外科系講座耳鼻咽喉科頭頸部外科学分野（兵庫県）、兵庫県立がんセンター（兵庫県）、広島大学大学院医系科学研究科耳鼻咽喉科学・頭頸部外科学研究室（広島県）、国立病院機構四国がんセンター（愛媛県）、九州大学病院（福岡県）、久留米大学耳鼻咽喉科・頭頸部外科学講座（福岡県）、国立病院機構九州がんセンター（福岡県）、国立病院機構九州医療センター（福岡県）、国家公務員共済組合連合会浜の町病院（福岡県）、奈良県立医科大学耳鼻咽喉・頭頸部外科学（奈良県）、産業医科大学耳鼻咽喉科・頭頸部外科学（福岡県）、埼玉医科大学国際医療センター　頭頸部腫瘍科・耳鼻咽喉科（埼玉県）

Other administrative information
Date of disclosure of the study information	2019 Year 06 Month 17 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	111
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	2019 Year 05 Month 10 Day
Date of IRB	2019 Year 06 Month 28 Day
Anticipated trial start date	2019 Year 07 Month 02 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Prospective observational study Patients who meet the selection criteria, such as patients who are eligible for Nivolumab insurance for head and neck cancer cases with recurrence or distant metastasis. Difference in the expression level of TEX mRNA (alone, module) in each group (treatment response group VS non-response group and survival case over 12 months VS non-survival case) with treatment response rate and 1-year survival rate as the end point We identify biomarkers that predict the therapeutic effect of nivolumab, establish a simple companion diagnostic technique by liquid biopsy, and explore and construct a novel immunotherapeutic strategy through analysis of the tumor immune environment.

Management information
Registered date	2019 Year 06 Month 11 Day
Last modified on	2021 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042182