UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036063
Receipt number 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 2021/03/02 15:49:10

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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 Yohei
Middle name
Last name Tajima

Organization

Ono Pharmaceutical CO., LTD

Division name

Medical Affairs, Medical Planning 1

Zip code

541-8564

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 Jun
Middle name
Last name Okada

Organization

EP-CRSU Co., Ltd.

Division name

Clinical Research Headquarters Clinical Research Management Department

Zip code

162-0814

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 or person

Institute

Ono Pharmaceutical CO.,LTD.
Bristol-Myers Squibb K.K.

Institute

Department

Personal name



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

Ono Pharmaceutical CO.,LTD. "Medical and Health Research Involving Human Subjects" Ethics Committee

Address

8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi, Japan

Tel

06-6263-2992

Email

n.nishiwaki@ono.co.jp


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

https://pubmed.ncbi.nlm.nih.gov/33594427/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/33594427/

Number of participants that the trial has enrolled

46

Results

The ORRs of TT after NIVO and NIVO+IPI were 27 and 32% (all risks), and median PFSs were 8.9 and 16.3 months, respectively. During the treatment of first TT after either NIVO or NIVO+IPI, 98% of patients experienced treatment-related adverse events, including grade 3-4 events in 51% of patients, and no treatment-related deaths occurred.

Results date posted

2021 Year 03 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients participated in CheckMate 025 or CheckMate 214, treated with TT as subsequent therapy before March 31, 2019, after discontinuation of NIVO or NIVO+IPI were analyzed.

Participant flow

26 patients in CheckMate 025 and 19 patients in CheckMate 214 from 20 centers in Japan were retrospectively analyzed.

Adverse events

During the treatment of first TT after either NIVO or NIVO+IPI, 98% of patients experienced treatment-related adverse events, including grade 3-4 events in 51% of patients, and no treatment-related deaths occurred.

Outcome measures

As the first subsequent TT after NIVO or NIVO+IPI, axitinib was the most frequently treated regimen for both CheckMate 025 (54%) and CheckMate 214 (47%) patients. The ORRs of TT after NIVO and NIVO+IPI were 27 and 32% (all risks), and median PFSs were 8.9 and 16.3 months, respectively.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

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

2020 Year 05 Month 31 Day


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

2021 Year 03 Month 02 Day



Link to view the page

Value
https://center6.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