ClinicalTrials.gg
RecruitingNCT06882486NAMECARUpdated Oct 14, 2026

Post-immunotherapy Nephrectomy for Metastatic Kidney Cancer After Complete or Major Response to Systemic Therapy

An interventional study of nephrectomy in Kidney Cancer, sponsored by Institut Paoli-Calmettes. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Institut Paoli-Calmettes · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 108 studies in Kidney Neoplasms with a site in France — 31 open to participants now, 36 under way, 4 of them phase 3. Kidney Neoplasms · France.

Planned enrollment
50th of 78
60 · median 100
Started
2026
with 5 others
No phase
28 of 108
11 open now
Primary completion
2031-04
later than 32 of 35 live
Registered
99th of 108
by date

Among the 108 studies in Kidney Neoplasms with a site in France, this one is the 50th largest by planned enrollment of the 78 interventional ones that give a count, is one of 6 that started in 2026, is one of 28 with no phase, reaches primary completion later than 32 of the 35 other live ones, and was the 99th registered.

Kidney Neoplasms

969 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

Browse Kidney Neoplasms studies →

Open to participants now

31 of the 108 studies in Kidney Neoplasms with a site in France are open now. Recruiting first, the newest first:

25 more — sign in →

All 31 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 173 Kidney Neoplasms studies recruiting now, 133 (77%) set no upper age limit and 15 (9%) stop at 75 or younger; 20 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 108 studies in Kidney Neoplasms with a site in France, or all of them as a file.
02

Study summary

In the current era of immune checkpoint inhibitors (ICI), the role and timing of nephrectomy remains unknown, particularly in cases of residual kidney disease after a major response at metastatic sites. In these cases, the rationale for a delayed nephrectomy is that it might achieve a long-term response. This strategy could allow some patients to discontinue treatment and maintain tumor response. Furthermore, this approach might provide a potentially curative option for patients with metastases that are managed with and responding to ICI.

Regarding the results of our first retrospective cohort data (showing that two thirds of patients are free from recurrence without systemic treatment after nephrectomy), we designed a non-comparative randomized phase II trial assessing progression-free survival of patients with complete response or major partial response after ICI-based treatment, operated on delayed nephrectomy with discontinuation of systemic therapy (experimental arm) and in patients managed with continuation of systemic therapy without nephrectomy (control arm).

In a de-escalation approach, this strategy may have sense to allow patients with an excellent response to immunotherapy to stop systemic treatment with a curative objective and a substantial impact from a medico-economic point of view.

Read the detailed description

Patients with metastatic kidney cancer will be treated according to current first-line treatment guidelines.

Patients may be included in the study (by signing a consent form) and randomized if a complete response (CR) or metastatic partial response (mPR) (>75%) is achieved with immunotherapy-based systemic therapy.

In the centers participating in the ancillary study, patients in the experimental arm (arm A) will undergo renal MRI and PSMA PET (positron emission tomography) scan prior to nephrectomy.

Arm A patients will undergo nephrectomy (partial or enlarged, depending on technical possibilities and surgeon's discretion), after which systemic treatment will be discontinued.

Patients in arm B will not undergo surgery, and will continue their systemic treatment unchanged (interrupted in the event of toxicity, in accordance with current recommendations).

In both arms, follow-up will consist of a biological and CT scan evaluation every 3 months for 2 years.

The primary objective is to evaluate the efficacy of the experimental strategy in terms of progression-free survival, progression being defined according to the usual RECIST criteria.

03

Conditions studied

  • Kidney Cancer

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient aged ≥ 18 years
  2. Diagnosed with synchronous kidney cancer
  3. With primary tumor still in place (no primary cytoreductive nephrectomy)
  4. Having received systemic ICI immunotherapy-based combination therapy
  5. In CR or mPR (defined as >75% response in metastatic lesions from baseline) according to the (RECIST, version 1.1), excluding the primary renal lesion.
  6. Signed consent to participate
  7. Affiliated to the national social security scheme or beneficiaries of such a scheme

Exclusion criteria

Exclusion Criteria:

  1. Women who are or may become pregnant (without effective ) or who are breast-feeding.
  2. Person in an emergency situation or unable to give consent.
  3. An adult under legal protection (guardianship, curators or safeguard of justice),
  4. Inability to undergo medical follow-up for geographical, social or psychological reasons.
  5. Patients who have undergone prior cytoreductive nephrectomy
  6. Patients considering nephrectomy for symptomatic disease, but without major response (CR or mPR) in disease
  7. Patients with non-metastatic disease at diagnosis who have received ICI in a setting
  8. Patients with to surgery or ineligible for nephrectomy
  9. Patients not wishing to undergo nephrectomy
  10. Patients with end-stage renal disease
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    nephrectomy

    delayed nephrectomy and discontinuation of systemic treatment

    Procedure: nephrectomy

  • No intervention
    no nephrectomy

    no nephrectomy and continuation of systemic treatment

Interventions

  • Procedurenephrectomy

    Nephrectomy scheduled within 3 months of inclusion. Patients may continue their systemic treatment at the usual rate until D-5 prior to surgery. Treatment will not be resumed after surgery. Surgery may consist of partial or enlarged nephrectomy, with or without associated lymph node dissection, depending on technical possibilities and at the surgeon's discretion.

06

What researchers measure

Primary outcomes

  1. progression-free survival

    post-randomization progression-free survival

    Time frame: 24 month

Secondary outcomes

  1. Overall survival

    Overall post-randomization survival

    Time frame: 24 month

  2. Intraoperative and postoperative complications

    Rate of intraoperative and postoperative complications

    Time frame: 30 days

  3. Immunotherapy-related adverse events

    Rate of immunotherapy-related adverse events (including CTCAE grade ≥ 3)

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Apr 2031, 59 months after the start.

Of 90 non-industry interventional studies with no phase under Kidney Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 94. This study's planned 59 months is above that.

Counting every sponsor, half of 97 studies reached it within 42 months; a quarter within 21 and three quarters within 90.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2025
First posted
Mar 18, 2025
StartActual
May 13, 2026
Primary completionEst.
Apr 2031
CompletionEst.
Apr 2031
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and date precision
1 update, last Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    Minor edits only
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06882486
Responsible party
Sponsor
First posted
Mar 18, 2025
Start date
May 13, 2026
Primary completion
Apr 2031 (estimated)
Completion
Apr 2031 (estimated)
Last update
Oct 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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