Delayed kidney removal after a strong response to immunotherapy for metastatic kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Institut Paoli-Calmettes
  Marseille, Institut Paoli-calmettes, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.