UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II trial of nivolumab in advanced mucosal melanoma
Title of the study (Brief title)	A phase II trial of nivolumab in advanced mucosal melanoma
Region	Japan

Condition
Condition	mucosal melanoma
Classification by specialty	Gastroenterology Hematology and clinical oncology Obsterics and gynecology Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety and efficacy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Overall survival, progression free survival, disease control rate, response duration, time to response, best overall response, rate of change in tumor size, immuno-related disease control rate, immuno-related progression free survival, immuno-related response, toxicity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	nivolumab 2mg/kg, triweekly
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 proven mucosal melanoma 2) Aged 20 years old or more 3) metastatic or advanced disease 4) ECOG PS of 0 or 1 5) No need for previous treatment 6) Need for measurable lesion 7) No previous chest radiotherapy 8) Adequate organ functions 9) Written informed consent
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Active infection requiring systemic therapy. 3) Patients with immune suppression. 4) Patients with central nerve system metastases. 5) Patients with complications of autoimmune disease, histories of chronic and recurrent autoimmune disease or other diseases which require systemic steroid therapy or immune suppressor. 6) Patients received live vaccines. 7) Patients who received anti PD-1 antibody, anti PD-L1 antibody, anti PD-L2 antibody, anti CD137 antibody, or anti CTLA-4 antibody. 8) Positive HBs antigen, or positive HCV antibody. 9) Pregnancy, possible pregnancy or breastfeeding. 10) Psychiatric disease. 11) Patients requiring systemic steroid medication. 12) Poorly controlled diabetes mellitus. 13) Severe pulmonary fibrosis or emphysema. 14) Patients whom principle/sub-investigator judged ineligible to participate in this study.
Target sample size	20

Research contact person
Name of lead principal investigator	Masashi Ando
Organization	Aichi Cancer Center Hospital
Division name	Department of Clinical Oncology
Address	1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
TEL	052-762-6111
Email	mandoh@aichi-cc.jp

Public contact
Name of contact person	Motoo Nomura
Organization	Kyoto University
Division name	Department of Therapeutic Oncology
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan.
TEL	075-751-3518
Homepage URL
Email	excell@hkg.odn.ne.jp

Sponsor
Institute	Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization	Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	愛知県がんセンター中央病院(愛知県)、京都大学(京都府)、倉敷中央病院(岡山県)、静岡県立静岡がんセンター(静岡県)、千葉大学(千葉県)、滋賀医科大学(滋賀県)

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 28 Day
Anticipated trial start date	2014 Year 12 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 04 Day
Last modified on	2017 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018439