NCT06882486Recruiting
Post-immunotherapy Nephrectomy for Metastatic Kidney Cancer After Complete or Major Response to Systemic Therapy
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 12 Mar 2025
- Start date
- 13 May 2026
- Primary completion date
- Apr 2031
- Lead sponsor
- Institut Paoli-Calmettes
- Diseases
- Kidney cancer
- NCT number
- NCT06882486
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 13 May 2026 to the primary completion date, Apr 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have undergone prior cytoreductive nephrectomy
- 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
Other illness
- Patients considering nephrectomy for symptomatic disease, but without major response (CR or mPR) in metastatic disease
- Patients with end-stage renal disease
Other
- 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 not wishing to undergo nephrectomy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.