Kidney CancerNORDIC-SUNNCT03977571
Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma: The NORDIC-SUN-Trial
A study testing Cytoreductive nephrectomy and Tissue sampling in people with Kidney Cancer and Renal Cell Carcinoma Metastatic, run by Niels Fristrup at 11 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer, Renal Cell Carcinoma Metastatic, Synchronous Neoplasm
- What is being tested?
- Cytoreductive nephrectomy and Tissue sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 6 Jul 2020to 1 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent obtained prior to any study specific procedures.
- Patient must be willing and able to comply with the protocol.
- Age ≥18.
- Core needle biopsy proven metastatic renal cell carcinoma - all histologic subtypes acceptable.
- Synchronous metastatic renal cell carcinoma with the primary tumor present in the kidney.
- Measurable disease as per RECIST v 1.1
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- 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.
- Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.
- 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).
- Karnofsky Performance status ≥70
- Life expectancy of greater than 4 months.
- 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)
Who cannot join
- Prior systemic treatment for mRCC
- Other cancer within 3 years (except in situ basal cell carcinoma and localised prostate cancer with undetectable PSA).
- Major surgical procedure, open surgical biopsy, or significant traumatic injury within 28 days prior to enrollment
- 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.
- No symptomatic brain metastasis requiring systemic corticosteroids (> 10 mg daily prednisone equivalent)
- Recent (within the 30 days prior to inclusion) treatment with another investigational drug or participation in another investigational study.
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- 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.
- Known hypersensitivity to monoclonal antibodies.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Any positive test for hepatitis B- or C-Virus indicating acute or chronic infection.
- Oral or i.v. antibiotics administered 14 days prior to initiation of systemic therapy.
Trial locations and contacts
11 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Ane Iversen, MD PhD contact
11 sites in 4 countries
Norway6 sites, 6 recruiting
- Recruiting
Department of Oncology, Ålesund Universitetsykehus
Ålesund
Bjørg Y Aksnessæther, MD, bjorg.y.aksnessether@helse-mr.no
Bjørg Y Aksnessæther, MD
- Recruiting
Department of Urology, Haukeland University Hospital
Bergen
Christian Beisland, Professor, 0047 47301005, christian.beisland@helse-bergen.no
Karin Hjelle, MD, 0047 92899241, karin.margrethe.hjelle@helse-bergen.no
- Recruiting
Centre for Cancer Treatment, Sørlandet Hospital Trust, Kristiansand
Kristiansand, 4615
Anne Helene Køstner, MD, PhD, 0047-38073000, anne.helene.kostner@sshf.no
Anne Helene Køstner, MD, PhD
- Recruiting
Department of Oncology, Stavanger Universitetssykehus
Stavanger
Maria N Vigmostad, MD, 0047 908 14 524, maria.nyre.vigmostad@sus.no
Maria N Vigmostad, MD
- Recruiting
Center for Cancer and Blood Diseases, Vestfold Hospital Trust
Tønsberg, Vestfold, 3103
Marius Ioan-Taran, MD, 0047-33342000, matara@siv.no
Marius Ioan-Taran, MD
- Recruiting
Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital
Trondheim, 7030
Martine Hansen Gaarder, MD, 0047-72573000, martine.hansen.gaarder@stolav.no
Martine Hansen Gaarder, MD
Denmark3 sites, 3 recruiting
- Recruiting
Department of Oncology, Aarhus University Hospital
Aarhus, Central Region of Denmark, 8200
Niels Fristrup, MD PhD, 004520914161, niels.fristrup@rm.dk
- Recruiting
Department of Oncology, Herlev Hospital
Herlev, 2730
Anne Kirstine Moeller, MD, PhD, anne.kirstine.moeller.darras@regionh.dk
Jesper Palshof, MD PhD, Jesper.Andreas.Palshof@regionh.dk
- Recruiting
Department of Oncology, Odense University Hospital
Odense, 5000
Jon R Henriksen, MD, Jon.Henriksen@rsyd.dk
Niels Viggo Jensen, MD, Niels.Viggo.Jensen@rsyd.dk
Finland1 site, 1 recruiting
- Recruiting
Clinical Trial Unit, Helsinki University Central Hospital
Helsinki
Katriina Jalkanen, MD, PhD, katriina.jalkanen@hus.fi
Katriina Jalkanen, MD, PhD
Sweden1 site, 1 recruiting
- Recruiting
Department of Oncology, Karolinska University Hospital
Stockholm, SSE-17177
Magnus Lindskog, MD, PhD, magnus.lindskog@regionstockholm.se
Per-Olof Lundgren, MD, PhD, per-olof.lundgren@regionstockholm.se
About this study
Official title: Multicenter Randomized Trial of Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma Receiving Checkpoint Inhibitors: a Trial Evaluating the Impact of Surgery or No Surgery. The NORDIC-SUN-Trial
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
Read more
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.
Read the detailed description
OUTLINE: This is a multicenter trial, patients are stratified according to institution, treatment choice, 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 or a TKI/IO-combination, 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 at 2nd evaluation 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 or a TKI/IO-combination.
ARM B: No surgery, receive maintenance nivolumab or a TKI/IO-combination.
Patients undergo tumor tissue, blood, and stool collection at baseline, 3 and 6 months, for planned translational research.
- Being tested
- Cytoreductive nephrectomy, Tissue sampling
- Keywords
- Cytoreduction Surgical Procedures, Nephrectomy, Ipilimumab, Nivolumab, Laboratory biomarker analysis, Gene Expression, Liquid Biopsy
- Medical subject headings
- Kidney Neoplasms, Neoplasms, Multiple Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive nephrectomyProcedure or surgery
Partial or complete nephrectomy by open, laparoscopic, or robotic approach.
Tissue samplingOther
Tumor biopsies, blood, and stool specimens for translational biomarker research will be sampled at baseline and after 3 or 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Deferred nephrectomy | Experimental | Surgery after induction therapy with IO/IO or a TKI/IO-combination, followed by maintenance therapy with nivolumab or a TKI/IO-combination. Receives: Procedure: Cytoreductive nephrectomy; Other: Tissue sampling |
| No surgery | Active comparator | Induction therapy wih IO/IO or a TKI/IO-combination, followed by maintenance therapy with nivolumab or a TKI/IO-combination. Receives: Other: Tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Calculated from the date of inclusion, to the date of death of any cause or censored at the date at last follow-up.
Measured: Minimum 3 years follow-up
Secondary outcomes (12)
Progression free survival
According to the RECIST v1.1
Measured: 3 years follow-up
Time to subsequent systemic therapy
Calculated from date of inclusion to date of initiation of subsequent therapy or death of any cause or censored at the date of last follow-up
Measured: 3 years follow-up
Objective response rate
According to the RECIST v1.1
Measured: 3 years follow-up
Rate of patients meeting randomization criteria
Compared with baseline values
Measured: 3 or 6 months
Fractional percentage of tumor volume (ratio of primary tumor measurement to total sum of target lesions) to survival outcome in deferred cytoreductive nephrectomy patients and no surgery patients
Compared with baseline values
Measured: 3 years follow-up
Number of participants with treatment-related adverse events as by Common Terminology Criteria for Adverse Events version 5.0.
Evaluation of adverse events
Measured: 3 years follow-up
Number of participant with surgical morbidity assessed according to the Clavien-Dindo classification of surgical complications
Evaluation of surgical morbidity
Measured: 3 years follow-up
Tumor infiltrating lymphocytes baseline and after surgery compared with OS, PFS, TST, ORR
As part of a biomarker analysis
Measured: 3 year follow-up
Immune subsets in blood measured by flowcytometry in serial samples compared with OS, PFS, TST, ORR.
As part of a biomarker analysis
Measured: 3 year follow-up
Genetic profile of circulation tumor DNA measured by Next generation sequencing (NGS), compared with OS, PFS, TST, ORR.
As part of a biomarker analysis
Measured: 3 year follow-up
Genetic profile of primary tumor tissue measured by measured by NGS compared with OS, PFS, TST, ORR.
As part of a biomarker analysis
Measured: 3 year follow-up
Profile of gut microbiome measured by NGS compared OS, PFS, TST, ORR.
As part of a biomarker analysis
Measured: 3 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start6 Jul 2020
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niels Fristrup
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Niels Fristrup, Aarhus University Hospital
- Investigators
- Niels Fristrup, MD PhD, Principal investigator, Department of Oncology, Aarhus University Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977571
- Sponsor's protocol ID
- NORDIC-SUN
- Acronym
- NORDIC-SUN
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2019
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Flammia RS, Campi R, Bologna E, Bertolo R, Leonardo C, Calabro F, Amparore D, Simone G; Young Academic Urologists (YAU) Renal Cancer Working Group. Cytoreductive nephrectomy in the era of immune-checkpoint inhibitors: back to the future? BJU Int. 2026 May;137(5):763-769. doi: 10.1111/bju.70168. Epub 2026 Feb 11.
PubMed 41673778Iisager L, Ahrenfeldt J, Donskov F, Ljungberg B, Bex A, Lund L, Lyskjaer I, Fristrup N. Multicenter randomized trial of deferred cytoreductive nephrectomy in synchronous metastatic renal cell carcinoma receiving checkpoint inhibitors: the NORDIC-SUN-Trial. BMC Cancer. 2024 Feb 24;24(1):260. doi: 10.1186/s12885-024-11987-3.
PubMed 38402173Kuusk T, Abu-Ghanem Y, Mumtaz F, Powles T, Bex A. Perioperative therapy in renal cancer in the era of immune checkpoint inhibitor therapy. Curr Opin Urol. 2021 May 1;31(3):262-269. doi: 10.1097/MOU.0000000000000868.
PubMed 33742979
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Trial of Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma Receiving Checkpoint Inhibitors: a Trial Evaluating the Impact of Surgery or No Surgery. The NORDIC-SUN-Trial
- ClinicalTrials.gov ID
- NCT03977571
- Acronym / sponsor ID
- NORDIC-SUN / NORDIC-SUN
- Keywords
- Cytoreduction Surgical Procedures, Nephrectomy, Ipilimumab, Nivolumab, Laboratory biomarker analysis, Gene Expression, Liquid Biopsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Niels FristrupUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OUTLINE: This is a multicenter trial, patients are stratified according to institution, treatment choice, 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 or a TKI/IO-combination, 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 at 2nd evaluation 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 or a TKI/IO-combination.
ARM B: No surgery, receive maintenance nivolumab or a TKI/IO-combination.
Patients undergo tumor tissue, blood, and stool collection at baseline, 3 and 6 months, for planned translational research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deferred nephrectomy | Experimental | Procedure: Cytoreductive nephrectomy, Other: Tissue samplingSurgery after induction therapy with IO/IO or a TKI/IO-combination, followed by maintenance therapy with nivolumab or a TKI/IO-combination. |
| No surgery | Active comparator | Other: Tissue samplingInduction therapy wih IO/IO or a TKI/IO-combination, followed by maintenance therapy with nivolumab or a TKI/IO-combination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed written informed consent obtained prior to any study specific procedures.
- Patient must be willing and able to comply with the protocol.
- Age ≥18.
- Core needle biopsy proven metastatic renal cell carcinoma - all histologic subtypes acceptable.
- Synchronous metastatic renal cell carcinoma with the primary tumor present in the kidney.
Key exclusion criteria (11 listed)
- Prior systemic treatment for mRCC
- Other cancer within 3 years (except in situ basal cell carcinoma and localised prostate cancer with undetectable PSA).
- Major surgical procedure, open surgical biopsy, or significant traumatic injury within 28 days prior to enrollment
- 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.
- No symptomatic brain metastasis requiring systemic corticosteroids (> 10 mg daily prednisone equivalent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytoreductive nephrectomyPartial or complete nephrectomy by open, laparoscopic, or robotic approach. | Procedure or surgery | Deferred nephrectomy |
| Tissue samplingTumor biopsies, blood, and stool specimens for translational biomarker research will be sampled at baseline and after 3 or 6 months. | Other | Deferred nephrectomy, No surgery |
Primary outcome
Overall survival
Time frame: Minimum 3 years follow-up
Calculated from the date of inclusion, to the date of death of any cause or censored at the date at last follow-up.
12 secondary outcomes
Progression free survival
Time frame: 3 years follow-up
Time to subsequent systemic therapy
Time frame: 3 years follow-up
Objective response rate
Time frame: 3 years follow-up
Rate of patients meeting randomization criteria
Time frame: 3 or 6 months
Fractional percentage of tumor volume (ratio of primary tumor measurement to total sum of target lesions) to survival outcome in deferred cytoreductive nephrectomy patients and no surgery patients
Time frame: 3 years follow-up
Number of participants with treatment-related adverse events as by Common Terminology Criteria for Adverse Events version 5.0.
Time frame: 3 years follow-up
Number of participant with surgical morbidity assessed according to the Clavien-Dindo classification of surgical complications
Time frame: 3 years follow-up
Tumor infiltrating lymphocytes baseline and after surgery compared with OS, PFS, TST, ORR
Time frame: 3 year follow-up
Immune subsets in blood measured by flowcytometry in serial samples compared with OS, PFS, TST, ORR.
Time frame: 3 year follow-up
Genetic profile of circulation tumor DNA measured by Next generation sequencing (NGS), compared with OS, PFS, TST, ORR.
Time frame: 3 year follow-up
Genetic profile of primary tumor tissue measured by measured by NGS compared with OS, PFS, TST, ORR.
Time frame: 3 year follow-up
Profile of gut microbiome measured by NGS compared OS, PFS, TST, ORR.
Time frame: 3 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Derived from this study: PubMed 41673778Flammia RS, Campi R, Bologna E, Bertolo R, Leonardo C, Calabro F, Amparore D, Simone G; Young Academic Urologists (YAU) Renal Cancer Working Group. Cytoreductive nephrectomy in the era of immune-checkpoint inhibitors: back to the future? BJU Int. 2026 May;137(5):763-769. doi: 10.1111/bju.70168. Epub 2026 Feb 11.
- Derived from this study: PubMed 38402173Iisager L, Ahrenfeldt J, Donskov F, Ljungberg B, Bex A, Lund L, Lyskjaer I, Fristrup N. Multicenter randomized trial of deferred cytoreductive nephrectomy in synchronous metastatic renal cell carcinoma receiving checkpoint inhibitors: the NORDIC-SUN-Trial. BMC Cancer. 2024 Feb 24;24(1):260. doi: 10.1186/s12885-024-11987-3.
- Derived from this study: PubMed 33742979Kuusk T, Abu-Ghanem Y, Mumtaz F, Powles T, Bex A. Perioperative therapy in renal cancer in the era of immune checkpoint inhibitor therapy. Curr Opin Urol. 2021 May 1;31(3):262-269. doi: 10.1097/MOU.0000000000000868.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ane Iversen, MD PhD contact
Niels Fristrup, MD PhD principal investigator
Department of Oncology, Aarhus University Hospital.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytoreductive nephrectomy and Tissue sampling in people with Kidney Cancer and Renal Cell Carcinoma Metastatic, run by Niels Fristrup at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Norway, Denmark, Finland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niels Fristrup, MD PhD (004520914161, niels.fristrup@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Minimum 3 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03977571, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.