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

Sponsor
Institut Paoli-Calmettes
Study ID
NCT06882486
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nephrectomy — PROCEDURE
    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 Details

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.

Key Dates

First listed
Mar 18, 2025
Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2031
Completion
Apr 30, 2031

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: nephrectomy
    delayed nephrectomy and discontinuation of systemic treatment
  • No Intervention: no nephrectomy
    no nephrectomy and continuation of systemic treatment

Primary Outcome Measure

progression-free survival [ Time Frame: 24 month ]

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