UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031736
Receipt number R000036236
Scientific Title Prospective observational study of Japanese melanoma patients treated with combination therapy using nivolumab and ipilimiumab
Date of disclosure of the study information 2018/06/01
Last modified on 2018/09/13 11:47:38

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Basic information

Public title

Prospective observational study of Japanese melanoma patients treated with combination therapy using nivolumab and ipilimiumab

Acronym

Nivo/Ipi Combi-POS

Scientific Title

Prospective observational study of Japanese melanoma patients treated with combination therapy using nivolumab and ipilimiumab

Scientific Title:Acronym

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

1st name
Middle name
Last name Yasuhiro Fujisawa

Organization

University of Tsukuba

Division name

Dermatology

Zip code


Address

1-1-1 Tennodai, Tsukuba City

TEL

0298533128

Email

fujisan@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuhiro Fujisawa

Organization

University of Tsukuba

Division name

Dermatology

Zip code


Address

1-1-1 Tennodai, Tsukuba City

TEL

0298533128

Homepage URL


Email

fujisan@md.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Terminated

Date of protocol fixation

2018 Year 03 Month 14 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036236


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name