Immediate versus Deferred nephrectomy with Immunotherapy in Patients with Metastatic Kidney Cancer

Immediate versus Deferred Cytoreductive Nephrectomy with Ipilimumab/Nivolumab in Metastatic Clear cell Renal Cell Carcinoma: A Multicenter, Randomized, Open-Label Phase II Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0010857

Enrollment

172

Registered

2025-08-07

Start date

2025-12-01

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

None listed

Interventions

Drug, Procedure/Surgery : Upfront CN Group: Upfront cytoreductive nephrectomy will be performed. Within 6 weeks after surgery, 4 cycles of induction therapy with ipilimumab (1 mg/kg) and nivolumab (3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Men and women aged 19 years or older ? Patients with primary renal cell carcinoma and metastatic lesions simultaneously confirmed by imaging studies at the time of diagnosis, and clear cell renal cell carcinoma (RCC) confirmed by biopsy of the renal tumor ? ECOG performance status 0-1 ? Patients with measurable metastatic lesions ? Primary RCC within the resectable range ? IMDC risk of intermediate to poor risk ? Life expectancy > 3 months ? Females of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use appropriate contraception during the study period ? Patients who can read and voluntarily give consent

Exclusion criteria

Exclusion criteria: ? A person who has previously undergone systemic treatment for metastatic kidney cancer ? A person diagnosed with or treated for another cancer within two years ? Patients who are not eligible to participate in clinical trials due to comorbidities such as moderate or higher cardiovascular disease, cerebrovascular disease, respiratory or liver disease, etc ? Patients with a history of autoimmune diseases or suspected autoimmune diseases are not suitable for the treatment of immuno-cancer drugs ? A person who needs more than 10 mg of systemic steroid therapy or immunosuppressants, etc ? a woman who is pregnant or nursing ? A person whose participation in other clinical trials is deemed inappropriate by the tester a patient who did not ? A person who needs more than 10 mg of systemic steroid therapy or immunosuppressants, etc ? a woman who is pregnant or nursing ? A person whose participation in other clinical trials is deemed inappropriate by the tester

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Overall survival;Surgical morbidity ;Rate of RECIST, version 1.1 complete and partial response(PR) to Ipilimumab/Nivolumab;Quality of life score	—

Countries

Korea, Republic of

Contacts

Public ContactJinhee Yu

Seoul National University Hospital

eueua99@snu.ac.kr+82-2-2072-2428

Outcome results