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

NCT06882486 | Recruiting

• 1 other identifier: NAMECAR-IPC 2024-054
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  post-randomization progression-free survival

  24 month

Secondary Outcomes (3)

• Overall survival

  24 month

• Intraoperative and postoperative complications

  30 days

• Immunotherapy-related adverse events

  24 months

Study Arms (2)

nephrectomy

EXPERIMENTAL

delayed nephrectomy and discontinuation of systemic treatment

Procedure: nephrectomy

no nephrectomy

NO INTERVENTION

no nephrectomy and continuation of systemic treatment

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.

nephrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, Institut Paoli-calmettes, 13273, France

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Nephrectomy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

FR (1)