Actively Recruiting
The Role of Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma in Immuno-oncology Era: SEVURO-CN Trial
Led by Yonsei University · Updated on 2023-06-22
40
Participants Needed
3
Research Sites
443 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
BACKGROUND: The role of cytoreductive nephrectomy (CN) in the treatment of metastatic renal cell carcinoma (mRCC) has been questioned and remains undetermined in the immuno-oncology era. Results from the two randomized trials, CARMENA and SURTIME, have questioned the role and timing of the surgery in these patients, however, these trials have only used the targeted therapy, sunitinib. With the advent of more effective systemic therapies including immune checkpoint inhibitors (ICIs), the role of surgical therapy should be reexamined. RATIONALE: The therapeutic effects of ICIs have demonstrated improved oncological outcomes compared to sunitinib. The updated results reported the beneficial role of upfront and deferred CN approach for selected patients. No studies have formally investigated the role of CN in the immune-oncology era where combinatorial use of CN plus ICIs might be beneficial. HYPOTHESIS: Upfront or deferred CN will improve oncological outcomes (overall survival, and progression free survival) in patients with synchronous mRCC and ≤3 IMDC risk features compared to immune checkpoint inhibitors (nivolumab plus ipilimumab combination) alone. This is an open, randomized, multicenter comparison trial, designed to evaluate the effect of the potential role of CN in combination with immunotherapy in mRCC patients with IMDC intermediate and poor risk.
CONDITIONS
Official Title
The Role of Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma in Immuno-oncology Era: SEVURO-CN Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Core needle biopsy confirmed metastatic renal cell carcinoma with clear cell subtype only
- Synchronous metastatic renal cell carcinoma with primary tumor present in the kidney
- Willing to provide human-derived materials
- Age 19 years or older
- Signed informed consent before any study procedures
- Willing and able to follow the study protocol
- Measurable disease as per RECIST v1.1
- Life expectancy greater than 4 months
- Intermediate or poor risk by IMDC criteria (more than one prognostic factor)
- Nivolumab/Ipilimumab treatment considered indicated by national health authorities
- Karnofsky Performance status of 70 or higher
- Females must have negative pregnancy test unless not of childbearing potential and not lactating
- Fertile women and men must use effective contraception
- Adequate bone marrow, liver, and kidney function based on specified laboratory values
You will not qualify if you...
- Prior systemic treatment for metastatic renal cell carcinoma
- Major surgery, open biopsy, or significant injury within 28 days before enrollment
- Other cancer diagnosed within past 5 years
- Active significant cardiovascular disease (events within 6 months)
- Symptomatic brain metastasis requiring systemic corticosteroids over 10 mg prednisone daily
- Treatment with another investigational drug or study participation within 30 days
- Active or recent autoimmune disease requiring systemic steroids or immunosuppressants (except certain conditions)
- Use of oral or intravenous antibiotics within 14 days before systemic therapy start
- Positive test for hepatitis B or C indicating acute or chronic infection
- Known hypersensitivity to monoclonal antibodies
- Known HIV infection or AIDS
- Refusal to provide human-derived materials
- Unwilling or unable to comply with the protocol
- Vulnerable populations (children, prisoners, pregnant women, mentally disabled, economically or educationally disadvantaged)
- Unable to read or understand the consent form (e.g., illiterate or non-native speakers)
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Gangnam Severance Hospital
Seoul, South Korea
Not Yet Recruiting
2
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Actively Recruiting
3
Yongin Severance Hospital
Yongin-si, South Korea
Not Yet Recruiting
Research Team
W
Won Sik Ham
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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