Delayed kidney removal after a strong response to immunotherapy for metastatic kidney cancer
Post-immunotherapy Nephrectomy for Metastatic Kidney Cancer After Complete or Major Response to Systemic Therapy
NA · Institut Paoli-Calmettes · NCT06882486
This trial will test whether removing the remaining kidney after a very good response to immunotherapy lets people with metastatic kidney cancer stop systemic treatment and keep the cancer under control.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Paoli-Calmettes (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Marseille, Institut Paoli-calmettes) |
| Trial ID | NCT06882486 on ClinicalTrials.gov |
What this trial studies
This is a randomized phase II trial that enrolls adults with synchronous metastatic kidney cancer who have a complete response or a major partial response (>75% reduction) in metastatic sites after immune checkpoint inhibitor–based therapy. Eligible patients are randomized to delayed nephrectomy with discontinuation of systemic therapy versus continued systemic treatment without surgery. In some participating centers the surgical arm will receive preoperative renal MRI and PSMA PET; follow-up in both arms includes labs and CT scans every three months for two years. The primary outcome is progression-free survival measured by RECIST v1.1.
Who should consider this trial
Good fit: Adults with synchronous metastatic kidney cancer who still have their primary tumor in place and have achieved a complete response or a major (>75%) metastatic response after immunotherapy, and who are fit for surgery and regular follow-up, are the intended participants.
Not a fit: Patients who have not achieved a major response, who already had a prior cytoreductive nephrectomy, who are poor surgical candidates, pregnant, or unable to comply with follow-up are unlikely to benefit from the surgical strategy tested here.
Why it matters
Potential benefit: If successful, this approach could allow some patients to stop ongoing immunotherapy while maintaining long-term tumor control and could offer a chance of cure for select patients.
How similar studies have performed: Retrospective cohort data from the investigators suggested about two thirds of selected patients were recurrence-free off treatment after nephrectomy, but randomized prospective data on this exact approach are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient aged ≥ 18 years 2. Diagnosed with synchronous metastatic 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 Response Evaluation Criteria in Solid Tumors (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: 1. Women who are or may become pregnant (without effective contraception) 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 metastatic disease 7. Patients with non-metastatic disease at diagnosis who have received ICI in a neo-adjuvant setting 8. Patients with contraindications to surgery or ineligible for nephrectomy 9. Patients not wishing to undergo nephrectomy 10. Patients with end-stage renal disease
Where this trial is running
Marseille, Institut Paoli-calmettes
- Institut Paoli-Calmettes — Marseille, Institut Paoli-calmettes, France (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Cancer