UMIN-CTR Clinical Trial

Basic information
Public title	Carbon-ion radiotherapy followed by Nivolumab for primary mucosal malignant melanoma of the head and neck
Acronym	iROCK-2001HN
Scientific Title	Prospective observational study of the efficacy and safety of carbon-ion radiotherapy followed by Nivolumab for primary mucosal malignant melanoma of the head and neck
Scientific Title:Acronym	iROCK-2001HN
Region	Japan

Condition
Condition	mucosal malignant melanoma of the head and neck
Classification by specialty	Oto-rhino-laryngology Radiology Oral surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of carbon-ion radiotherapy followed by Nivolumab for primary mucosal malignant melanoma of the head and neck.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	One-year progression-free survival after Nivolumab
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	1)Histologically or cytologically confirmed mucosal malignant melanoma of the head and neck 2)Patients where radical carbon-ion radiotherapy is possible 3)Eastern Cooperative Oncology Group (ECOG) performance status 0 -2 4)Patients aged 20 years or older at the time of consent 5)Measurable disease, according to RECIST version 1.1 6)Life expectancy of greater than 12 weeks in the opinion of the investigator 7)Ability to understand and the willingness to sign written informed consent documents
Key exclusion criteria	1)Patients with interstitial pneumonia, drug-induced interstitial lung disease or clinically active interstitial lung disease on chest CT scan 2)Patients with autoimmune disorders 3)Known allergy to compounds of similar chemical or biologic composition to Nivolumab 4)Pregnant or lactating females 5)Patients in which the physician decides that participation in the study is unsuitable
Target sample size	34

Research contact person
Name of lead principal investigator	1st name Nobutaka Middle name Last name Mizoguchi
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name	Department of Radiation Oncology
Zip code	241-8515
Address	2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa prefecture, JAPAN
TEL	045-520-2222
Email	mizoguchin@kcch.jp

Public contact
Name of contact person	1st name Nobutaka Middle name Last name Mizoguchi
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name	Department of Radiation Oncology
Zip code	241-8515
Address	2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa prefecture, JAPAN
TEL	045-520-2222
Homepage URL
Email	mizoguchin@kcch.jp

Sponsor
Institute	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Institute
Department

Funding Source
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	KCCH support center for the development of new therapies
Address	2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa prefecture, JAPAN
Tel	045-520-2222
Email	chiken-jimu4@kcch.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	2020 Year 10 Month 26 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	Open public recruiting
Date of protocol fixation	2020 Year 10 Month 01 Day
Date of IRB	2020 Year 10 Month 12 Day
Anticipated trial start date	2020 Year 10 Month 19 Day
Last follow-up date	2025 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study design: -single-center prospective observational study Research agenda: -Prospective observational study of the efficacy and safety of carbon ion radiotherapy followed by Nivolumab for primary mucosal malignant melanoma of the head and neck Eligibility: -Patients with malignant mucosal melanoma of the head and neck -Patients who will be seen at our facility between October 2020 and September 2023, meet the selection criteria, and consent to this study Primary endpoint: -One-year progression-free survival after Nivolumab

Management information
Registered date	2020 Year 10 Month 24 Day
Last modified on	2020 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048210