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Timing is everything: new trial tests surgery before or after immunotherapy for kidney cancer

NCT ID NCT07233668

Disease control Sponsor: Seoul National University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This clinical trial is for adults with metastatic clear cell kidney cancer. It compares having surgery to remove the kidney tumor either before or after starting immunotherapy drugs (ipilimumab and nivolumab). The goal is to see which timing helps people live longer without the cancer growing. 172 participants will be randomly assigned to one of the two groups and followed for 15 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ipilimumab and Nivolumab (immunotherapy drugs)
What this could lead to
If successful, this trial could show the best timing for surgery combined with immunotherapy, potentially improving survival and quality of life for people with metastatic kidney cancer.
What could go wrong
This is a Phase 3 trial, but it's not yet recruiting and results are years away. The benefit of timing may be small, and both surgery and immunotherapy carry risks of serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 172 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

clear cell renal carcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic renal cell carcinoma ( MRCC)

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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