UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study of Japanese melanoma patients treated with combination therapy using nivolumab and ipilimiumab
Title of the study (Brief title)	Nivo/Ipi Combi-POS
Region	Japan

Condition
Condition	Melanoma, advanced
Classification by specialty	Dermatology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigate safety and efficacy of combination therapy using nivolumab and ipilimumab
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Best overall response, overall surviva, adverse events
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Advanced melanoma patients who have never treated with immune checkpoint inhibitors and planning to treat with nivolumab+ipilimumab combination therapy
Key exclusion criteria	Prior treatment with immune checkpoint inhibitors
Target sample size	100

Research contact person
Name of lead principal investigator	Yasuhiro Fujisawa
Organization	University of Tsukuba
Division name	Dermatology
Address	1-1-1 Tennodai, Tsukuba City
TEL	0298533128
Email	fujisan@md.tsukuba.ac.jp

Public contact
Name of contact person	Yasuhiro Fujisawa
Organization	University of Tsukuba
Division name	Dermatology
Address	1-1-1 Tennodai, Tsukuba City
TEL	0298533128
Homepage URL
Email	fujisan@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Self-funding
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

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 03 Month 14 Day
Anticipated trial start date	2018 Year 06 Month 01 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	None

Management information
Registered date	2018 Year 03 Month 14 Day
Last modified on	2018 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036236