Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma: The NORDIC-SUN-Trial
Status:
Recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
BACKGROUND: For synchronous metastatic renal cell carcinoma (RCC), surgical resection of the
primary tumor in the presence of distant metastases has been the standard of therapy for
select patients followed by systemic therapy. In the era of TKIs two randomized trials,
CARMENA and SURTIME, have questioned the role and timing of surgery in these patients,
results point towards no surgery or a deferred approach.
RATIONALE: The antitumor activity of immune checkpoint blockage (ICB) is more potent than
other therapy in mRCC. The deferred cytoreductive nephrectomy approach ensures systemic
therapy for all patients, avoid systemic treatment delay, and spare surgery in patients with
progressive tumors. Current data only point towards a survival benefit for cytoreductive
nephrectomy in intermediate risk patients, but not in poor risk patients
HYPOTHESIS: Deferred cytoreductive nephrectomy after initial nivolumab combined with
ipilimumab will improve OS in patients with synchronous metastatic RCC and ≤3 IMDC risk
features
This is an open, randomized, multicenter, phase III comparison trial, designed to evaluate
the effect of deferred cytoreductive nephrectomy compared with no surgery following initial
nivolumab combined with ipilimumab, in mRCC patients with IMDC intermediate and poor risk.