Cytoreductive nephrectomy in the era of immune-checkpoint inhibitors: back to the future?
Rocco Simone Flammia, Riccardo Campi, Eugenio Bologna...
https://pubmed.ncbi.nlm.nih.gov/41673778Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03977571
Multicenter Randomized Trial of Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma Receiving Checkpoint Inhibitors Evaluating Surgery Versus No Surgery
Led by Niels Fristrup ยท Updated on 2026-05-04
400
Participants Needed
6
Research Sites
156 weeks
Total Duration
On this page
Sponsors
N
Niels Fristrup
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma: The NORDIC-SUN-Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Willing and able to follow the study protocol
- Age 18 years or older
- Biopsy-confirmed metastatic renal cell carcinoma of any histologic subtype
- Presence of primary kidney tumor with synchronous metastases
- Measurable disease per RECIST v1.1 criteria
- Eligible for treatment with nivolumab/ipilimumab or TKI/immunotherapy combination as per guidelines
- Negative pregnancy test for females unless not of childbearing potential
- Women of childbearing potential and men must use effective contraception
- Karnofsky Performance Status of 70 or higher
- Life expectancy greater than 4 months
- Adequate bone marrow, liver, and kidney function as specified by lab values
You will not qualify if you...
- Prior systemic treatment for metastatic renal cell carcinoma
- Other cancers within 3 years except certain localized skin or prostate cancers
- Major surgery or significant injury within 28 days before enrollment
- Active significant cardiovascular disease within 6 months
- Symptomatic brain metastases requiring corticosteroids above 10 mg prednisone equivalent
- Recent participation in another investigational drug study within 30 days
- Active or recent autoimmune disease requiring systemic immunosuppression, with some exceptions
- Known allergy to monoclonal antibodies
- Positive test for HIV or AIDS
- Positive test for hepatitis B or C infection
- Use of oral or intravenous antibiotics within 14 days before starting systemic therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Induction Treatment
Duration - 3 months
Participants receive induction checkpoint immunotherapy with nivolumab combined with ipilimumab or a TKI/IO-combination immediately after inclusion.
Approximately 4 treatment series during induction
Evaluation for Surgery Eligibility
Duration - 1 visit (at 3 months)
Participants are assessed at 3 months for suitability for cytoreductive nephrectomy at a multidisciplinary team meeting.
1 visit (in-person)
Continuation of Systemic Therapy or Randomization
Duration - 3 months
Participants not suitable for surgery or with more than 3 risk factors continue systemic therapy for 3 additional months, followed by a second evaluation for surgery eligibility.
Ongoing systemic therapy with regular visits as per treatment protocol
Second Evaluation for Surgery Eligibility
Duration - 1 visit (at 6 months)
Participants are reassessed at 6 months for suitability for cytoreductive nephrectomy.
1 visit (in-person)
Deferred Cytoreductive Nephrectomy (for eligible participants)
Duration - Surgery and immediate post-operative care up to 2 years of maintenance therapy
Participants deemed suitable undergo partial or complete nephrectomy by open, laparoscopic, or robotic approach, followed by maintenance therapy with nivolumab or a TKI/IO-combination.
Surgery visit plus ongoing maintenance visits as per treatment protocol
Maintenance Therapy Without Surgery (for participants not undergoing surgery)
Duration - Up to 2 years from inclusion
Participants continue maintenance therapy with nivolumab or a TKI/IO-combination after induction therapy without surgery.
Regular maintenance visits as per treatment protocol
Long-term Follow-up
Duration - Minimum 3 years follow-up
Participants are followed for overall survival and other outcomes for a minimum of 3 years after treatment initiation.
Periodic follow-up visits as scheduled
Trial Site Locations
Total: 6 locations
1
Department of Oncology, Aarhus University Hospital
Aarhus, Central Region of Denmark, Denmark, 8200
Actively Recruiting
2
Department of Oncology, Herlev Hospital
Herlev, Denmark, 2730
Actively Recruiting
3
Department of Oncology, Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
4
Department of Oncology, ร lesund Universitetsykehus
ร lesund, Norway
Actively Recruiting
5
Department of Urology, Haukeland University Hospital
Bergen, Norway
Actively Recruiting
6
Department of Oncology, Stavanger Universitetssykehus
Stavanger, Norway
Actively Recruiting
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Research Team
N
Niels Fristrup, MD PhD
A
Ane Iversen, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Multicenter randomized trial of deferred cytoreductive nephrectomy in synchronous metastatic renal cell carcinoma receiving checkpoint inhibitors: the NORDIC-SUN-Trial.
Laura Iisager, Johanne Ahrenfeldt, Frede Donskov...
https://pubmed.ncbi.nlm.nih.gov/38402173Perioperative therapy in renal cancer in the era of immune checkpoint inhibitor therapy.
Teele Kuusk, Yasmin Abu-Ghanem, Faiz Mumtaz...
https://pubmed.ncbi.nlm.nih.gov/33742979