NCT03977571: NORDIC-SUN

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

Recruiting now NA Last updated 17 June 2025

What this trial tests

NA trial testing Cytoreductive nephrectomy in Kidney Cancer in 400 participants. Currently enrolling.

Timeline

6 July 2020

Primary endpoint
1 September 2026

1 September 2029

Quick facts

Lead sponsor	Niels Fristrup
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	400
Start date	6 July 2020
Primary completion	1 September 2026
Estimated completion	1 September 2029
Sites	4 locations across Denmark, Norway

Drugs / interventions tested

• Cytoreductive nephrectomy
• Tissue sampling

Conditions studied

• Kidney Cancer — all drugs for Kidney Cancer →
• Renal Cell Carcinoma Metastatic — all drugs for Renal Cell Carcinoma Metastatic →
• Synchronous Neoplasm — all drugs for Synchronous Neoplasm →

Sponsor

Niels Fristrup

Who can join

18 and older, any sex, with Kidney Cancer or Renal Cell Carcinoma Metastatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 or a TKI/IO-combination will improve OS in patients with synchronous metastatic RCC and ≤3 IMDC risk features

This is an open, randomized, multicenter comparison trial, designed to evaluate the effect of deferred cytoreductive nephrectomy compared with no surgery following initial nivolumab combined with ipilimumab or a TKI-combination, in mRCC patients with IMDC intermediate and poor risk.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tissue-specific Tregs in cancer metastasis: opportunities for precision immunotherapy.
   Huppert LA, Green MD, Kim L, Chow C, et al · · 2022 · cited 95× · PMID 34417572 · DOI 10.1038/s41423-021-00742-4
2. Treatment Landscape of Renal Cell Carcinoma.
   Chen YW, Wang L, Panian J, Dhanji S, et al · · 2023 · cited 87× · PMID 38153686 · DOI 10.1007/s11864-023-01161-5
3. Clear Cell Renal Cell Carcinoma: From Biology to Treatment.
   Kase AM, George DJ, Ramalingam S. · · 2023 · cited 58× · PMID 36765622 · DOI 10.3390/cancers15030665
4. First-line Nivolumab plus Ipilimumab Versus Sunitinib in Patients Without Nephrectomy and With an Evaluable Primary Renal Tumor in the CheckMate 214 Trial.
   Albiges L, Tannir NM, Burotto M, McDermott D, et al · · 2022 · cited 56× · PMID 34750035 · DOI 10.1016/j.eururo.2021.10.001
5. Renal Cell Carcinoma and Kidney Transplantation: A Narrative Review.
   Dahle DO, Skauby M, Langberg CW, Brabrand K, et al · · 2022 · cited 43× · PMID 33741842 · DOI 10.1097/tp.0000000000003762
6. Current Advance of Immune Evasion Mechanisms and Emerging Immunotherapies in Renal Cell Carcinoma.
   Jian Y, Yang K, Sun X, Zhao J, et al · · 2021 · cited 40× · PMID 33767709 · DOI 10.3389/fimmu.2021.639636
7. First-Line Treatments for Metastatic Clear Cell Renal Cell Carcinoma: An Ever-Enlarging Landscape.
   Gulati S, Labaki C, Karachaliou GS, Choueiri TK, et al · · 2022 · cited 30× · PMID 35641205 · DOI 10.1093/oncolo/oyab056
8. Current and emerging therapies for first line treatment of metastatic clear cell renal cell carcinoma.
   Serzan MT, Atkins MB. · · 2021 · cited 30× · PMID 35295921 · DOI 10.20517/2394-4722.2021.76