Clinical Trial

Immediate Versus Deferred Cytoreductive Nephrectomy With Ipilimumab/Nivolumab in mRCC

Study acronym: IVE in mRCC
Not Yet Recruiting
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Summary
The goal of this clinical trial is to learn whether the timing of surgery (cytoreductive nephrectomy) improves outcomes when combined with immunotherapy (ipilimumab and nivolumab) in adults with metastatic clear cell renal cell carcinoma. The main questions this study aims to answer are: * Does upfront (immediate) surgery before immunotherapy improve survival compared to delayed surgery after immunotherapy? * What medical problems (side effects or complications) occur with each treatment sequence? * How do the two strategies affect quality of life? Researchers will compare two groups: * Upfront surgery group: Participants will have surgery first, then receive 4 cycles of ipilimumab/nivolumab, followed by nivolumab maintenance. * Deferred surgery group: Participants will receive 4 cycles of ipilimumab/nivolumab first, then surgery, followed by nivolumab maintenance. Participants will: * Be randomly assigned to one of the two groups * Undergo regular clinic visits, imaging tests, and blood collections for safety and biomarker studies * Be followed for 15 months to check disease progression, complications, survival, and quality of life This trial will help determine the best timing for surgery in the era of immunotherapy and provide evidence for improved treatment strategies for patients with metastatic kidney cancer
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-14.
Trial Details
NCT Number NCT07233668
Lead Sponsor Seoul National University Hospital
Conditions Metastatic Renal Cell Carcinoma ( mRCC)
Enrollment 172 participants
Start Date 2025-12-01
Primary Completion 2028-10-01 (estimated)
Study Completion 2029-02-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-03