Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Multiple Primary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Ipilimumab

Cytoreductive nephrectomy±metastasectomy, followed by induction therapy with nivolumab plus ipilimumab combination and maintenance therapy with nivolumab.

Cytoreductive nephrectomy±metastasectomy after induction therapy with nivolumab plus ipilimumab combination, followed by maintenance therapy with nivolumab.

Induction therapy with nivolumab plus ipilimumab combination, followed by maintenance therapy with nivolumab.

Partial or complete nephrectomy by open, laparoscopic, or robotic approach and/or metastasectomy Tumor tissue, blood, urine and stool specimens for translational biomarker research will be sample at baseline, surgery, after induction therapy, and after 3 months of maintenance therapy.

Cytoreductive nephrectomy±metastasectomy

Tumor tissue, blood, urine and stool specimens for translational biomarker research will be sample at baseline, after induction therapy, and after 3 months of maintenance therapy.

Human-derived materials sampling

Won Sik Ham

Kang Su Cho

Jongchan Kim

BACKGROUND: The role of cytoreductive nephrectomy (CN) in the treatment of metastatic renal cell carcinoma (mRCC) has been questioned and remains undetermined in the immuno-oncology era. Results from the two randomized trials, CARMENA and SURTIME, have questioned the role and timing of the surgery in these patients, however, these trials have only used the targeted therapy, sunitinib. With the advent of more effective systemic therapies including immune checkpoint inhibitors (ICIs), the role of surgical therapy should be reexamined.

RATIONALE: The therapeutic effects of ICIs have demonstrated improved oncological outcomes compared to sunitinib. The updated results reported the beneficial role of upfront and deferred CN approach for selected patients. No studies have formally investigated the role of CN in the immune-oncology era where combinatorial use of CN plus ICIs might be beneficial.

HYPOTHESIS: Upfront or deferred CN will improve oncological outcomes (overall survival, and progression free survival) in patients with synchronous mRCC and ≤3 IMDC risk features compared to immune checkpoint inhibitors (nivolumab plus ipilimumab combination) alone.

This is an open, randomized, multicenter comparison trial, designed to evaluate the effect of the potential role of CN in combination with immunotherapy in mRCC patients with IMDC intermediate and poor risk.

The Role of Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma in Immuno-oncology Era: SEVURO-CN Trial

Calculated from the date of inclusion, to the date of death of any cause or censored at the date at last follow-up.

By Common Terminology Criteria for Adverse Events version 5.0

Assessed according to the Clavien-Dindo classification of surgical complications

Measured by flowcytometry at baseline and after surgery and/or after ICIs compared with OS, PFS, ORR

Measured by Next generation sequencing (NGS) methods compared with OS, PFS, and ORR

Measured by NGS methods compared with OS, PFS, and ORR

Evaluate the microbiome composition measured by NGS methods compared with OS, PFS, and ORR

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Role of Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma in Immuno-oncology Era: SEVURO-CN Trial	NCT05753839	Kidney Cancer Clear Cell Rena... Synchronous Neo...	Cytoreductive n... Cytoreductive n... Human-derived m...	18 Years -	Yonsei University
The Role of Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma in Immuno-oncology Era: SEVURO-CN Trial	NCT05753839	Kidney Cancer Clear Cell Rena... Synchronous Neo...	Cytoreductive n... Cytoreductive n... Human-derived m...	18 Years -	Yonsei University

Spots Global Cancer Trial Database for cytoreductive nephrectomy±metastasectomy