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Immediate Versus Deferred Cytoreductive Nephrectomy With Ipilimumab/Nivolumab in mRCC

NCT07233668 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2025-12-03

No results posted yet for this study

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

Conditions

  • Metastatic Renal Cell Carcinoma ( mRCC)

Interventions

DRUG

Ipilimumab plus Nivolumab

Participants will receive 4 cycles of ipilimumab combined with nivolumab as induction therapy, followed by nivolumab maintenance depending on randomization schedule (before or after surgery).

PROCEDURE

Cytoreductive Nephrectomy

Surgical removal of the primary kidney tumor (cytoreductive nephrectomy), performed either upfront (before systemic therapy) or deferred (after 4 cycles of ipilimumab/nivolumab induction), depending on randomization arm.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Chang Wook Jeong, MD, PhD · Seoul National Universtiy Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2028-10-01
Completion
2029-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07233668 on ClinicalTrials.gov