Multiinstitutional prospective interventional study of biomarkers to predict efficacy and prognosis after nivolumab in patients with previously treated advanced renal cell carcinoma.

Multiinstitutional prospective interventional study of biomarkers to predict efficacy and prognosis after nivolumab in patients with previously treated advanced renal cell carcinoma. - Multiinstitutional prospective interventional study of biomarkers to predict efficacy and prognosis after nivolumab in patients with previously treated advanced renal cell carcinoma.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030400

Enrollment

200

Registered

2018-04-01

Start date

2018-04-01

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

Advanced renal cell carcinoma patients who need secondary or tertiary therapy

Interventions

Nivolumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Advanced renal cell carcinoma with unresectable or metastatic history who had been treated with tyrosine kinase inhibitors, Over 20 years old patients confirmed CT/MRI, Neutrophils > 1500cells/mm2, platelets > 75000cells/mm2, hemoglobin >9.0g/dl, AST < 78IU/l, ALT < 85IU/l, total bilirubin < 1.5mg/dl, serum creatinine > 2.0mg/dl, written informed consent

Exclusion criteria

Exclusion criteria: Patients who have been administered immune checkpoint inhibitors including nivolumab in the past Patients who have a history of malignant tumors other than renal cell carcinoma and are judged not to be cured Patients who are merging psychiatric symptoms or psychiatric disorders and considered difficult to participate in the study Patients decided not applicable for this study by physician

Design outcomes

Primary

Measure	Time frame
Best Overall Response	—

Secondary

Measure	Time frame
OS,PFS,DSS	—

Countries

Japan

Contacts

Public ContactHideaki Miyake

Hamamatsu University School of Medicine Department of Urology

hmiyake@hama-med.ac.jp053-435-2306

Outcome results

None listed

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