The Role of Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma in Immuno-oncology Era: SEVURO-CN Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Core needle biopsy proven metastatic renal cell carcinoma - clear cell histologic subtypes only acceptable.
Synchronous metastatic renal cell carcinoma with the primary tumor present in the kidney.
Patient must be willing to provide their human-derived materials.
Age ≥19.
Disqualifiers
Prior systemic treatment for mRCC
Major surgical procedure, open surgical biopsy, or significant traumatic injury within 28 days prior to enrollment
Other cancer within 5 years.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cytoreductive nephrectomy±metastasectomy
Procedure/SurgeryPartial or complete nephrectomy by open, laparoscopic, or robotic approach and/or metastasectomy Tumor tissue, blood, urine and stool specimens for translational biomarker research will be sample at baseline, surgery, after induction therapy, and after 3 months of maintenance therapy.
Cytoreductive nephrectomy±metastasectomy
Procedure/SurgeryPartial or complete nephrectomy by open, laparoscopic, or robotic approach and/or metastasectomy Tumor tissue, blood, urine and stool specimens for translational biomarker research will be sample at baseline, surgery, after induction therapy, and after 3 months of maintenance therapy.
Human-derived materials sampling
Other interventionTumor tissue, blood, urine and stool specimens for translational biomarker research will be sample at baseline, after induction therapy, and after 3 months of maintenance therapy.
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: Upfront cytoreductive nephrectomyExperimental treatment 1 intervention
Group B: Deferred cytoreductive nephrectomyExperimental treatment 1 intervention
Group C: No surgeryActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
5 years follow-upSecondary outcomes
1
Progression free survival
According to the RECIST v1.1
Time frame
5 years follow-up2
Objective response rate
According to the RECIST v1.1
Time frame
5 years follow-up3
Number of participants with treatment-related adverse events
By Common Terminology Criteria for Adverse Events version 5.0
Time frame
5 years follow-up4
Number of participant with surgical morbidity assessed according to the Clavien-Dindo classification of surgical complications
Assessed according to the Clavien-Dindo classification of surgical complications
Time frame
5 years follow-upSponsors and contacts
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Source ClinicalTrials.gov