NORDIC-SUN Trial Comparing Deferred Surgery Versus No Surgery with Immunotherapy for Metastatic Kidney Cancer

What this Trial Is About

Researchers are studying the best approach for patients with synchronous metastatic renal cell carcinoma RCC, a type of kidney cancer that has spread to other parts of the body. This trial compares the effects of delaying surgery to remove the primary kidney tumor until after initial immunotherapy treatment versus not having surgery at all. The trial focuses on patients with intermediate or poor risk features according to a cancer risk scoring system and aims to understand how these approaches affect overall survival. Participants will begin with induction immunotherapy using either a combination of nivolumab and ipilimumab or a combination of tyrosine kinase inhibitor TKI and immunotherapy. After about three months, their eligibility for surgery is assessed by a local team of specialists. Those suitable and with certain risk features may be randomized to either have deferred surgery followed by maintenance therapy or continue with maintenance therapy without surgery. Patients not suitable for surgery continue systemic therapy and are re-evaluated later. Tissue, blood, and stool samples are collected at baseline and during follow-up for research. During the study, participants receive regular evaluations including tumor measurements and sample collections at baseline, 3 months, and 6 months. Researchers monitor overall survival as the primary outcome over at least three years, along with other measures like progression-free survival, response rate, and treatment-related side effects. Safety and surgical outcomes are tracked, and immunological and genetic markers are studied to understand treatment effects. Treatment with nivolumab may continue for up to two years unless side effects occur.

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