Unique ID issued by UMIN | UMIN000036063 |
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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 |
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)
AFTER I-O Study
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)
AFTER I-O Study
Japan |
METASTATIC RENAL CELL CARCINOMA
Urology |
Malignancy
NO
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.
Safety,Efficacy
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.
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.
Observational
Not applicable |
Not applicable |
Male and Female
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.
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.
46
1st name | Yohei |
Middle name | |
Last name | Tajima |
Ono Pharmaceutical CO., LTD
Medical Affairs, Medical Planning 1
541-8564
8-2, Kyutaromachi 1-Chome, Chuo-ku, Osaka-Shi, Osaka, Japan
0662632992
y.tajima@ono.co.jp
1st name | Jun |
Middle name | |
Last name | Okada |
EP-CRSU Co., Ltd.
Clinical Research Headquarters Clinical Research Management Department
162-0814
Acropolis TOKYO Bldg., 3F, 6-29 Shinogawamachi Shinjuku-ku, Tokyo, 162-0814, Japan
0358045045
prj-after_i-o@eps.co.jp
Ono Pharmaceutical CO.,LTD.
Bristol-Myers Squibb K.K.
Ono Pharmaceutical CO.,LTD.
Bristol-Myers Squibb K.K.
Profit organization
Ono Pharmaceutical CO.,LTD. "Medical and Health Research Involving Human Subjects" Ethics Committee
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi, Japan
06-6263-2992
n.nishiwaki@ono.co.jp
NO
2019 | Year | 03 | Month | 01 | Day |
https://pubmed.ncbi.nlm.nih.gov/33594427/
Published
https://pubmed.ncbi.nlm.nih.gov/33594427/
46
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.
2021 | Year | 03 | Month | 01 | Day |
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.
26 patients in CheckMate 025 and 19 patients in CheckMate 214 from 20 centers in Japan were retrospectively analyzed.
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.
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.
Completed
2019 | Year | 02 | Month | 08 | Day |
2019 | Year | 04 | Month | 10 | Day |
2019 | Year | 06 | Month | 01 | Day |
2019 | Year | 09 | Month | 30 | Day |
2020 | Year | 05 | Month | 31 | Day |
This study is a non-interventional, medical record review of clinical data collected from Japanese patients using an electronic data collection (EDC) system.
2019 | Year | 03 | Month | 01 | Day |
2021 | Year | 03 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041078
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