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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)

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000036063
Enrollment
46
Registered
2019-03-01
Start date
2019-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

METASTATIC RENAL CELL CARCINOMA

Interventions

None listed

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactJun Okada

EP-CRSU Co., Ltd. Clinical Research Headquarters Clinical Research Management Department

prj-after_i-o@eps.co.jp0358045045

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026