RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Niels Fristrup • ClinicalTrials.gov ID: NCT03977571

Registry updated: 2026-09-23

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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.

Interventions

Cytoreductive nephrectomy (Procedure)
Partial or complete nephrectomy by open, laparoscopic, or robotic approach.
Tissue sampling (Other)
Tumor biopsies, blood, and stool specimens for translational biomarker research will be sampled at baseline and after 3 or 6 months.

Eligibility criteria

Inclusion Criteria: 1. Signed written informed consent obtained prior to any study specific procedures. 2. Patient must be willing and able to comply with the protocol. 3. Age ≥18. 4. Core needle biopsy proven metastatic renal cell carcinoma - all histologic subtypes acceptable. 5. Synchronous metastatic renal cell carcinoma with the primary tumor present in the kidney. 6. Measurable disease as per RECIST v 1.1 7. Patients for which Nivolumab/Ipilimumab or a TKI/IO-combination is considered indicated according to the recommendations by the European Medicines Agency and the national health authorities of participating countries. The prescription of nivolumab/ipilimumab or a TKI/IO-combination in the circumstances of the study is considered as a standard treatment. 8. Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating. 9. Fertile women of childbearing potential (\<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization). 10. Karnofsky Performance status ≥70 11. Life expectancy of greater than 4 months. 12. The required laboratory values are as follows: * Adequate bone marrow function (Leucocytes \> 3.0 x 109/l, platelets \> 100 x 109/l, hemoglobin \> 6.0 mmol/l or \> 10.0 g/dL.) * International normalized ratio (INR) ≤ 1.2 x upper limit of normal (ULN) * Adequate hepatic function (bilirubin ≤ 1.5 x ULN, ALAT ≤ 2.5 x ULN or ≤ 5 x ULN if liver lesions) * Adequate kidney function (eGFR \> 35 mL/min) Exclusion Criteria: 1. Prior systemic treatment for mRCC 2. Other cancer within 3 years (except in situ basal cell carcinoma and localised prostate cancer with undetectable PSA). 3. Major surgical procedure, open surgical biopsy, or significant traumatic injury within 28 days prior to enrollment 4. Clinically significant (i.e active) cardiovascular disease for example cerebrovascular accidents (\< 6 months before inclusion), myocardial infarction (\< 6 months before inclusion), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure. 5. No symptomatic brain metastasis requiring systemic corticosteroids (\> 10 mg daily prednisone equivalent) 6. Recent (within the 30 days prior to inclusion) treatment with another investigational drug or participation in another investigational study. 7. Any active or recent history of a known or suspected autoimmune disease or recent history of a condition that require systemic corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications, excluding inhaled steroids and topical steroids. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, psoriasis not requiring systemic treatment are permitted to enroll. 8. Known hypersensitivity to monoclonal antibodies. 9. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 10. Any positive test for hepatitis B- or C-Virus indicating acute or chronic infection. 11. Oral or i.v. antibiotics administered 14 days prior to initiation of systemic therapy.

Conditions

Kidney Cancer Renal Cell Carcinoma Metastatic Synchronous Neoplasm

Locations

Department of Oncology, Aarhus University Hospital — Aarhus, Central Region of Denmark, Denmark
Department of Oncology, Herlev Hospital — Herlev, Denmark
Department of Oncology, Odense University Hospital — Odense, Denmark
Clinical Trial Unit, Helsinki University Central Hospital — Helsinki, Finland
Center for Cancer and Blood Diseases, Vestfold Hospital Trust — Tønsberg, Vestfold, Norway
Department of Oncology, Ålesund Universitetsykehus — Ålesund, Norway
Department of Urology, Haukeland University Hospital — Bergen, Norway
Centre for Cancer Treatment, Sørlandet Hospital Trust, Kristiansand — Kristiansand, Norway
Department of Oncology, Stavanger Universitetssykehus — Stavanger, Norway
Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital — Trondheim, Norway
Department of Oncology, Karolinska University Hospital — Stockholm, Sweden

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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