NCT07233668Not yet recruiting
Immediate Versus Deferred Cytoreductive Nephrectomy With Ipilimumab/Nivolumab in mRCC
Immediate Versus Deferred Cytoreductive Nephrectomy With Ipilimumab/Nivolumab in Metastatic Clear Cell Renal Cell Carcinoma: A Multicenter, Randomized, Open-Label, Phase III Trial
Source: ClinicalTrials.gov · Last updated 3 Dec 2025
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 172 (estimated)
- First submitted
- 3 Sept 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 1 Oct 2028
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Kidney cancer
- NCT number
- NCT07233668
What you commit to
- Study type: Interventional
- Planned participants: 172
- From 1 Dec 2025 to the primary completion date, 1 Oct 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic therapy for metastatic RCC.
- Requirement for systemic corticosteroid therapy \>10 mg/day prednisone equivalent, or other immunosuppressive drugs.
Other illness
- History of another malignancy diagnosed or treated within 2 years (except for cured non-melanoma skin cancer or in-situ cancers).
- Significant comorbid conditions making participation inappropriate, such as:
- Moderate to severe cardiovascular, cerebrovascular, pulmonary, or hepatic disease.
- History or suspicion of autoimmune disease incompatible with immune checkpoint inhibitor therapy.
- Any other condition judged by the investigator to make the patient unsuitable for trial participation.
Who the study is looking for
- Participants must meet all of the following:
- Age ≥ 19 years (male or female).
- Histologically confirmed synchronous metastatic clear cell renal cell carcinoma.
- ECOG performance status 0-1.
- At least one measurable metastatic lesion (per RECIST v1.1).
- Primary renal tumor considered surgically resectable.
- IMDC intermediate- or poor-risk classification.
- Estimated life expectancy \> 3 months.
- Ability to understand and voluntarily sign informed consent.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.