臨床研究等提出・公開システム

Date of registration	Dec. 15, 2017
Last modified on	July. 04, 2022
Trial ID	jRCT2080223754

Scientific Title	A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Nivolumab or Nivolumab plus Cisplatin, in Combination with Radiotherapy in Participants with Cisplatin Ineligible and Cisplatin Eligible Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN).(ONO-4538-66/CA2099TM )
Public Title	A phase III study of nivolumab(ONO-4538-66/CA2099TM )

Completion Date or Terminated date	Mar. 31, 2020
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	ONO PHARMACEUTICAL CO.,LTD.
	Address
	Phone Number
	E-mail Address	clinical_trial@ono.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	ONO PHARMACEUTICAL CO.,LTD.
	Address
	Phone Number	+81-120-626-190（受付時間：土・日・祝日を除く9:00−17:00）
	E-mail Address	clinical_trial@ono.co.jp

Recruitment Status	completed

Date of First Enrolment		Dec. 15, 2017
Target Sample Size		1046
Study Type		Interventional
Study Design	Study Design	Multicenter, Double-blind, Parallel Assignment, Randomized study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1. Histologically proven squamous cell carcinoma of the head and neck (SCCHN) from one of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx 2. Locally advanced disease which is unresectable, or resectable but suitable for an organ sparing approach 3. No previous radiotherapy or systemic treatment for SCCHN
	Exclusion Criteria	1. Carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histology (e.g., mucosal melanoma), squamous cell carcinoma of unknown primary 2. Clinical or radiological evidence of metastatic disease 3. Prior radiotherapy that overlaps with radiation fields
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Head and neck cancer
Intervention(s)		investigational material(s) Generic name etc : Nivolumab, Cisplatin INN of investigational material : Nivolumab, Cisplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : intravenous administration control material(s) Generic name etc : Cetuximab, Cisplatin INN of investigational material : Cetuximab, Cisplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : intravenous administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety 1.Adverse events(AEs) 2.Serious adverse events(SAEs)
Secondary Outcome		other -

Primary Sponsor	ONO PHARMACEUTICAL CO.,LTD.
Secondary Sponsor	Bristol-Myers Squibb

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Miyagi Cancer Center Institutional Review Board
Address of IRB	47-1 Nodayama, Medeshimashiote, Natori, Miyagi
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Jan. 19, 2018

Secondary ID No.	NCT03349710
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-173810
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/Europe/Oceania

History of Changes

No	Publication date
9	July. 04, 2022	(this page)	Changes
8	Oct. 14, 2020	Detail	Changes
7	July. 07, 2020	Detail	Changes
6	July. 16, 2019	Detail	Changes
5	Dec. 17, 2018	Detail	Changes
4	July. 24, 2018	Detail	Changes
3	July. 24, 2018	Detail	Changes
2	Dec. 15, 2017	Detail	Changes
1	Dec. 15, 2017	Detail

List of change history