Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma: The NORDIC-SUN-Trial

Summary

Participation Requirements

Description

OUTLINE: This is a multicenter trial, patients are stratified according to institution, number of IMDC risk factors, and combined elevated neutrophil-lymphocyte ratio and hyponatremia. All patients will receive induction checkpoint immunotherapy immediately after inclusion. After 3 months or a total...

OUTLINE: This is a multicenter trial, patients are stratified according to institution, number of IMDC risk factors, and combined elevated neutrophil-lymphocyte ratio and hyponatremia. All patients will receive induction checkpoint immunotherapy immediately after inclusion. After 3 months or a total of 4 series of nivolumab combined with ipilimumab, whichever comes first, the patient will be discussed for resectability at the multidisciplinary meeting (MDT). Whether the patient is eligible for cytoreductive nephrectomy is at the discretion of the urologist at the local MDT. Patients with ? 3 IMDC risk factors and deemed suitable for cytoreductive nephrectomy will then undergo randomization. Patients deemed not suitable for surgery or have > 3 IMDC risk features at the 3 month evaluation continue systemic therapy for 3 months, followed by a 2nd evaluation. Patients with ? 3 IMDC risk factors and deemed suitable for cytoreductive nephrectomy will then undergo randomization. Patients deemed not suitable for surgery or have > 3 IMDC risk features at the 6 month evaluation continue systemic therapy. Nivolumab may continue until unacceptable toxicity or total treatment length of 2 years from inclusion. ARM A: Deferred cytoreductive nephrectomy, followed by maintenance nivolumab. ARM B: No surgery, receive maintenance nivolumab alone. Patients undergo tumor tissue, blood, and stool collection at baseline, 3 and 6 months, for planned translational research.

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