Kidney CancerNAMECARNCT06882486
Post-immunotherapy Nephrectomy for Metastatic Kidney Cancer After Complete or Major Response to Systemic Therapy
A study testing nephrectomy in people with Kidney Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2026to Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged ≥ 18 years
- Diagnosed with synchronous metastatic kidney cancer
- With primary tumor still in place (no primary cytoreductive nephrectomy)
- Having received systemic ICI immunotherapy-based combination therapy
- In CR or mPR (defined as >75% response in metastatic lesions from baseline) according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), excluding the primary renal lesion.
- Signed consent to participate
- Affiliated to the national social security scheme or beneficiaries of such a scheme
Who cannot join
- Women who are or may become pregnant (without effective contraception) or who are breast-feeding.
- Person in an emergency situation or unable to give consent.
- An adult under legal protection (guardianship, curators or safeguard of justice),
- Inability to undergo medical follow-up for geographical, social or psychological reasons.
- Patients who have undergone prior cytoreductive nephrectomy
- Patients considering nephrectomy for symptomatic disease, but without major response (CR or mPR) in metastatic disease
Show all 10Show fewer
- Patients with non-metastatic disease at diagnosis who have received ICI in a neo-adjuvant setting
- Patients with contraindications to surgery or ineligible for nephrectomy
- Patients not wishing to undergo nephrectomy
- Patients with end-stage renal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Paoli-Calmettes
Marseille, Institut Paoli-calmettes, 13273
Jihane PAKRADOUNI, 0491223778, drci.up@ipc.unicancer.fr
About this study
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.
- Conditions
- Kidney Cancer
- Being tested
- nephrectomy
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nephrectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| nephrectomy | Experimental | delayed nephrectomy and discontinuation of systemic treatment Receives: Procedure: nephrectomy |
| no nephrectomy | No intervention | no nephrectomy and continuation of systemic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
post-randomization progression-free survival
Measured: 24 month
Secondary outcomes (3)
Overall survival
Overall post-randomization survival
Measured: 24 month
Intraoperative and postoperative complications
Rate of intraoperative and postoperative complications
Measured: 30 days
Immunotherapy-related adverse events
Rate of immunotherapy-related adverse events (including CTCAE grade ≥ 3)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start13 May 2026
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882486
- Sponsor's protocol ID
- NAMECAR-IPC 2024-054
- Acronym
- NAMECAR
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-immunotherapy Nephrectomy for Metastatic Kidney Cancer After Complete or Major Response to Systemic Therapy
- ClinicalTrials.gov ID
- NCT06882486
- Acronym / sponsor ID
- NAMECAR / NAMECAR-IPC 2024-054
- Conditions
- Kidney Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nephrectomy | Experimental | Procedure: nephrectomydelayed nephrectomy and discontinuation of systemic treatment |
| no nephrectomy | No intervention | –no nephrectomy and continuation of systemic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient aged ≥ 18 years
- Diagnosed with synchronous metastatic kidney cancer
- With primary tumor still in place (no primary cytoreductive nephrectomy)
- Having received systemic ICI immunotherapy-based combination therapy
- In CR or mPR (defined as >75% response in metastatic lesions from baseline) according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), excluding the primary renal lesion.
Key exclusion criteria (10 listed)
- Women who are or may become pregnant (without effective contraception) or who are breast-feeding.
- Person in an emergency situation or unable to give consent.
- An adult under legal protection (guardianship, curators or safeguard of justice),
- Inability to undergo medical follow-up for geographical, social or psychological reasons.
- Patients who have undergone prior cytoreductive nephrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nephrectomyNephrectomy 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. | Procedure or surgery | nephrectomy |
Primary outcome
progression-free survival
Time frame: 24 month
post-randomization progression-free survival
3 secondary outcomes
Overall survival
Time frame: 24 month
Intraoperative and postoperative complications
Time frame: 30 days
Immunotherapy-related adverse events
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nephrectomy in people with Kidney Cancer, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.