Deferred surgery for kidney cancer with metastases
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
This study is testing whether waiting to do kidney surgery after starting treatment for kidney cancer with metastases can help patients live longer compared to having surgery right away.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | Nivolumab, Ipilimumab, prednisone, immunotherapy |
| Locations | 6 sites (Aarhus, Central Region of Denmark and 5 other locations) |
| Trial ID | NCT03977571 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of deferred cytoreductive nephrectomy in patients with synchronous metastatic renal cell carcinoma (RCC). Participants will receive initial immunotherapy with nivolumab and ipilimumab or a TKI/IO combination before being evaluated for surgery after three months. The study aims to determine whether delaying surgery improves overall survival compared to immediate surgery, particularly focusing on patients with intermediate risk factors. The trial includes a randomization process for those eligible for surgery based on their risk assessment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with synchronous metastatic renal cell carcinoma and measurable disease.
Not a fit: Patients with poor risk factors or those not suitable for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates for patients with metastatic kidney cancer by optimizing treatment timing.
How similar studies have performed: Previous studies have shown mixed results regarding the timing of surgery in metastatic RCC, making this approach both relevant and novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aarhus, Central Region of Denmark and 5 other locations
- Department of Oncology, Aarhus University Hospital — Aarhus, Central Region of Denmark, Denmark (Recruiting)
- Department of Oncology, Herlev Hospital — Herlev, Denmark (Recruiting)
- Department of Oncology, Odense University Hospital — Odense, Denmark (Recruiting)
- Department of Oncology, Ålesund Universitetsykehus — Ålesund, Norway (Recruiting)
- Department of Urology, Haukeland University Hospital — Bergen, Norway (Recruiting)
- Department of Oncology, Stavanger Universitetssykehus — Stavanger, Norway (Recruiting)
Study contacts
- Principal investigator: Niels Fristrup, MD PhD — Department of Oncology, Aarhus University Hospital.
- Study coordinator: Niels Fristrup, MD PhD
- Email: niels.fristrup@rm.dk
- Phone: 004520914161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.