UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028628
Receipt number R000032762
Scientific Title A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan
Date of disclosure of the study information 2017/08/10
Last modified on 2020/01/15 11:37:49

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Basic information

Public title

A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan

Acronym

A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma

Scientific Title

A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan

Scientific Title:Acronym

A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma

Region

Japan


Condition

Condition

Melanoma

Classification by specialty

Dermatology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Describe treatment patterns in sequential treatment with nivolumab and ipilimumab

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Treatment patterns in sequential treatment with nivolumab and ipilimumab

Key secondary outcomes

-Overall response rate (ORR)
-Best overall response rate (BORR)
-Overall survival (OS)
-Progression-free survival (PFS)
-Incidence of treatment-related adverse events (AEs)
-Severity of treatment-related adverse events (AEs)


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

-Adult patients > 18 years of age or older
-Diagnosis of advanced melanoma (unresectable/metastatic), alive or deceased as of date of data collection
-Treated with ipilimumab between 31-Aug-2015 and 31-Mar-2017 before or after nivolumab treatment

Key exclusion criteria

-Patients enrolled in any clinical trials at any time
-Overlapping use of nivolumab and ipilimumab

Target sample size

82


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eijun Itakura

Organization

Bristol-Myers Squibb

Division name

Oncology Medical GU & Melanoma

Zip code


Address

6-5-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo 163-1327

TEL

03-6705-7583

Email

eijun.itakura@bms.com


Public contact

Name of contact person

1st name
Middle name
Last name Eijun Itakura

Organization

Bristol-Myers Squibb

Division name

Oncology Medical GU & Melanoma

Zip code


Address

6-5-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo 163-1327

TEL

03-6705-7583

Homepage URL


Email

eijun.itakura@bms.com


Sponsor or person

Institute

Bristol-Myers Squibb

Institute

Department

Personal name



Funding Source

Organization

Bristol-Myers Squibb

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Ono Pharmaceutical Co., Ltd.

Name of secondary funder(s)

Ono Pharmaceutical Co., Ltd.


IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

CA209-9DA

Org. issuing International ID_1

Bristol-Myers Squibb

Study ID_2

NCT03165422

Org. issuing International ID_2

ClinicalTrials.gov

IND to MHLW



Institutions

Institutions

札幌医科大学附属病院(北海道)、国立がん研究センター中央病院(東京都)、信州大学医学部附属病院(長野県)、静岡がんセンター(静岡県)、名古屋大学医学部附属病院(愛知県)、大阪大学医学部附属病院(大阪府)、岡山大学病院(岡山県)、熊本大学医学部附属病院(熊本県)


Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 10 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

Completed

Date of protocol fixation

2017 Year 03 Month 08 Day

Date of IRB

2017 Year 07 Month 11 Day

Anticipated trial start date

2017 Year 08 Month 24 Day

Last follow-up date

2018 Year 03 Month 15 Day

Date of closure to data entry

2018 Year 03 Month 15 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded

2018 Year 05 Month 25 Day


Other

Other related information

This is an observational, retrospective medical chart review design that will be implemented with clinical data to be abstracted from patient medical records in Japan.


Management information

Registered date

2017 Year 08 Month 10 Day

Last modified on

2020 Year 01 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032762


Research Plan
Registered date File name
2020/01/15 ca2099da-prot_final.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name