Evaluating surgery's role in metastatic kidney cancer treatment with immunotherapy
The Role of Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma in Immuno-oncology Era: SEVURO-CN Trial
This study is testing if surgery combined with new immune treatments can help people with advanced kidney cancer live longer and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | Nivolumab, Ipilimumab, prednisone, sunitinib, immunotherapy |
| Locations | 3 sites (Seoul and 2 other locations) |
| Trial ID | NCT05753839 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of cytoreductive nephrectomy (CN) in patients with metastatic renal cell carcinoma (mRCC) in the context of modern immunotherapy. It aims to determine whether upfront or deferred CN, combined with immune checkpoint inhibitors, can improve overall survival and other oncological outcomes compared to previous studies that only considered targeted therapies. The study will include patients with clear cell histologic subtypes of mRCC who meet specific eligibility criteria, including measurable disease and a life expectancy of over four months. Participants will undergo surgical procedures and provide human-derived materials for further analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with biopsy-proven clear cell metastatic renal cell carcinoma and a life expectancy of more than four months.
Not a fit: Patients with non-clear cell renal cell carcinoma or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and treatment outcomes for patients with metastatic kidney cancer.
How similar studies have performed: Previous studies have raised questions about the role of surgery in mRCC, but this trial is novel as it specifically examines the combination of surgery with modern immunotherapy approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Core needle biopsy proven metastatic renal cell carcinoma - clear cell histologic subtypes only acceptable.
2. Synchronous metastatic renal cell carcinoma with the primary tumor present in the kidney.
3. Patient must be willing to provide their human-derived materials.
4. Age ≥19.
5. Signed written informed consent obtained prior to any study specific procedures.
6. Patient must be willing and able to comply with the protocol.
7. Measurable disease as per RECIST v 1.1
8. Life expectancy of greater than 4 months.
9. Patients with more than one prognostic factor by the International Metastatic RCC Database Consortium (IMDC) criteria (intermediate- or poor-risk group).
10. Patients for which Nivolumab/Ipilimumab considered indicated according to the recommendations by the national health authorities. The prescription of nivolumab/ipilimumab in the circumstances of the study is considered as a standard treatment.
11. Karnofsky Performance status ≥70
12. Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.
13. 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).
14. The required laboratory values are as follows:
* Adequate bone marrow function (Absolute neutrophil count \> 1500/mm3, platelets \> 100 x 103/µl, hemoglobin \> 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)
* Adequate kidney function (eGFR \> 35 mL/min)
Exclusion Criteria:
1. Prior systemic treatment for mRCC
2. Major surgical procedure, open surgical biopsy, or significant traumatic injury within 28 days prior to enrollment
3. Other cancer within 5 years.
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. Oral or i.v. antibiotics administered 14 days prior to initiation of systemic therapy.
9. Any positive test for hepatitis B- or C-Virus indicating acute or chronic infection.
10. Known hypersensitivity to monoclonal antibodies.
11. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
12. Patients disagreeing to provide their human-derived materials.
13. Patients not willing and able to comply with the protocol.
14. Vulnerable subjects (such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons).
15. Patients who cannot read and understand the consent form. (illiterate, foreigners, etc.)
Where this trial is running
Seoul and 2 other locations
- Gangnam Severance Hospital — Seoul, South Korea (Not_yet_recruiting)
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)
- Yongin Severance Hospital — Yongin-si, South Korea (Not_yet_recruiting)
Study contacts
- Principal investigator: Won Sik Ham — Department of Urology and Urological Science Institute, Yonsei University College of Medicine
- Study coordinator: Won Sik Ham
- Email: uroham@yuhs.ac
- Phone: 02-2228-2310
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.