Immediate Versus Deferred Cytoreductive Nephrectomy With Ipilimumab/Nivolumab in mRCC (NCT07233668) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Immediate Versus Deferred Cytoreductive Nephrectomy With Ipilimumab/Nivolumab in mRCC
172 participantsStarted 2025-12-01
Plain-language 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
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Prior systemic therapy for metastatic RCC.
* 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.
* Requirement for systemic corticosteroid therapy \>10 mg/day prednisone equivalent, or other immunosuppressive drugs.
* Any other condition judged by the investigator to make the patient unsuitable for trial participation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival (PFS) assessed by RECIST version 1.1
Timeframe: Up to 15 months after treatment initiation