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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036063
Receipt No. R000041078
Scientific Title EFFICACY AND SAFETY OF SUBSEQUENT MOLECULAR TARGETED THERAPY AFTER IMMUNO-CHECKPOINT THERAPY, RETROSPECTIVE STUDY OF JAPANESE METASTATIC RENAL CELL CARCINOMA PATIENTS (AFTER I-O Study)
Date of disclosure of the study information 2019/03/01
Last modified on 2019/07/10

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Basic information
Public title EFFICACY AND SAFETY OF SUBSEQUENT MOLECULAR TARGETED THERAPY AFTER IMMUNO-CHECKPOINT THERAPY, RETROSPECTIVE STUDY OF JAPANESE METASTATIC RENAL CELL CARCINOMA PATIENTS (AFTER I-O Study)
Acronym AFTER I-O Study
Scientific Title EFFICACY AND SAFETY OF SUBSEQUENT MOLECULAR TARGETED THERAPY AFTER IMMUNO-CHECKPOINT THERAPY, RETROSPECTIVE STUDY OF JAPANESE METASTATIC RENAL CELL CARCINOMA PATIENTS (AFTER I-O Study)
Scientific Title:Acronym AFTER I-O Study
Region
Japan

Condition
Condition METASTATIC RENAL CELL CARCINOMA
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of the molecular targeted therapy, after nivolumab mono-therapy or nivolumab plus ipilimumab combination therapy, of patients in CheckMate025 and CheckMate214 studies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patients of CheckMate025 study : Overall response rate of molecular targeted therapy after nivolumab mono-therapy.
Patients of CheckMate214 study : Overall response rate of molecular targeted therapy after nivolumab plus ipilimumab combination therapy.
Key secondary outcomes Safety data of molecular targeted therapy after immune checkpoint inhibitor therapy of patients in CheckMate025 and CheckMate214 studies.
Overall response rate of molecular targeted therapy after immune checkpoint inhibitor therapy of patients in CheckMate025 and CheckMate214 studies.
Overall survival from discontinuation of immune checkpoint inhibitor therapy, overall survival of molecular targeted therapy, progression free survival of molecular targeted therapy, time to treatment failure of molecular targeted therapy, tumor reduction rate of molecular targeted therapy, treatment free survival after discontinuation of immune checkpoint inhibitor therapy.
Subgroup analysis of efficacy and safety of molecular targeted therapy.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients randomized to nivolumab arm in CheckMate025 study, and treated with molecular targeted therapy after discontinuation of nivolumab mono-therapy.
Patients randomized to nivolumab and ipilimumab combination therapy arm in CheckMate214 study, and treated with molecular targeted therapy after discontinuation of nivolumab and ipilimumab combination therapy.
Key exclusion criteria Patients treated with investigational agent after immune checkpoint inhibitor therapy.
Patients withdrew the consent of clinical trials (CheckMate025 or CheckMate214) before this analysis.
Patients treated with nivolumab after immune checkpoint inhibitor therapy.
Target sample size 46

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yohei Tajima
Organization Ono Pharmaceutical CO., LTD
Division name Medical Affairs, Medical Planning 1
Zip code
Address 8-2, Kyutaromachi 1-Chome, Chuo-ku, Osaka-Shi, Osaka, Japan
TEL 0662632992
Email y.tajima@ono.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Okada
Organization EP-CRSU Co., Ltd.
Division name Clinical Research Headquarters Clinical Research Management Department
Zip code
Address Acropolis TOKYO Bldg., 3F, 6-29 Shinogawamachi Shinjuku-ku, Tokyo, 162-0814, Japan
TEL 0358045045
Homepage URL
Email prj-after_i-o@eps.co.jp

Sponsor
Institute Ono Pharmaceutical CO.,LTD.
Bristol-Myers Squibb K.K.
Institute
Department

Funding Source
Organization Ono Pharmaceutical CO.,LTD.
Bristol-Myers Squibb K.K.
Organization
Division
Category of Funding Organization Profit organization
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
2019 Year 03 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 No longer recruiting
Date of protocol fixation
2019 Year 02 Month 08 Day
Date of IRB
2019 Year 04 Month 10 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a non-interventional, medical record review of clinical data collected from Japanese patients using an electronic data collection (EDC) system.

Management information
Registered date
2019 Year 03 Month 01 Day
Last modified on
2019 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041078

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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