Ipilimumab plus nivolumab with prophlactic dexamethasone in patients with advanced renal cell carcinoma

A multicenter randomized clinical trial of ipilimumab plus nivolumab with prophlactic dexamethasone therapy in patients with advanced renal cell carcinoma comparing with a historical control trearted with traditional ipilimumab plus nivolumab therapy.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041210108

Enrollment

Registered

2021-11-24

Start date

2022-01-18

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

Renal cell carcinoma advanced renal cell carcinoma

Interventions

Prophyratic dexamethasone infusion during ipilimumab plus nivolmub therapy for advanced renal cell carcinoma

D000082082

Ipilimumab plus nivolumab therapy, prophyratic dexamethasone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) 20-90 years old patients who were diagnosed as advanced renal cell carcinoma and had an indication for Ipilimumab plus nivolumab therapy (2) Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0, 1, 2, or 3 (3) labolatory data includes the following criteria a) WBC: more than 3,000 /mm3 b) Hb: more than 8.0g/dL c) PLT: more than 100000/mm3 d) AST(GOT), ALT(GPT): AST Less than 66 mg/dL, ALT Less than 54 mg/dL e) Total Bil: Less than 1.5mg/dL (4) Patients who can get hospitalized for this study (5) Patients who were obtained written informed consent

Exclusion criteria

Exclusion criteria: (1) women with pregnant or its possibily (2) Hisory of Having allegies to ipilimumab or nivolumab therapy (3) active multiple cancer (4) Taking a steroid or immunosuppressive drug (5) uncontoralble diabetes (6) Judged as an inappropriate patient by the investigator or sub-investigator

Design outcomes

Primary

Measure	Time frame
incidence of G3 irAE after IPI/NIVO+Dex	—

Secondary

Measure	Time frame
1) continuatuin rate for IPI/NIVO + DEX thearpy 2) response rate of IP/NIVO + DEX thearpy 3) laboratory changes 4) overall survival duraion after IP/NIVO+DE therapy	—

Contacts

Public ContactShuzo Hamamoto

Nagoya City University Hospital

hamamo10@med.nagoya-cu.ac.jp+81-52-853-8266

Outcome results

None listed

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