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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028628
Receipt No. 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 2018/08/13

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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
-Document the efficacy, including overall response rate (ORR), best overall response rates (BORR), overall survival (OS), and progression-free survival (PFS) clinical outcomes among patients who received sequential treatment with nivolumab and ipilimumab
-Evaluate the incidence and describe the severity of treatment-related adverse events (AEs) and their management
-Document the reason of ending or switching 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
Institute Bristol-Myers Squibb
Institute
Department

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 No longer recruiting
Date of protocol fixation
2017 Year 03 Month 08 Day
Date of IRB
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
2018 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032762

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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