Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma: The NORDIC-SUN-Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNiels Fristrup
About this trial
BACKGROUND: For synchronous metastatic renal cell carcinoma (RCC), surgical resection of the primary tumor in the presence of distant metastases has been the standard of therapy for select patients followed by systemic therapy. In the era of TKIs two randomized trials, CARMENA and SURTIME, have questioned the role and timing of surgery in these patients, results point towards no surgery or a deferred approach.
RATIONALE: The antitumor activity of immune checkpoint blockage (ICB) is more potent than other therapy in mRCC. The deferred cytoreductive nephrectomy approach ensures systemic therapy for all patients, avoid systemic treatment delay, and spare surgery in patients with progressive tumors. Current data only point towards a survival benefit for cytoreductive nephrectomy in intermediate risk patients, but not in poor risk patients
HYPOTHESIS: Deferred cytoreductive nephrectomy after initial nivolumab combined with ipilimumab or a TKI/IO-combination will improve OS in patients with synchronous metastatic RCC and ≤3 IMDC risk features
This is an open, randomized, multicenter comparison trial, designed to evaluate the effect of deferred cytoreductive nephrectomy compared with no surgery following initial nivolumab combined with ipilimumab or a TKI-combination, in mRCC patients with IMDC intermediate and poor risk.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed written informed consent obtained prior to any study specific procedures.
Patient must be willing and able to comply with the protocol.
Age ≥18.
Core needle biopsy proven metastatic renal cell carcinoma - all histologic subtypes acceptable.
Disqualifiers
Prior systemic treatment for mRCC
Other cancer within 3 years (except in situ basal cell carcinoma and localised prostate cancer with undetectable PSA).
Major surgical procedure, open surgical biopsy, or significant traumatic injury within 28 days prior to enrollment
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
Procedure/SurgeryPartial or complete nephrectomy by open, laparoscopic, or robotic approach.
Tissue sampling
Other interventionTumor biopsies, blood, and stool specimens for translational biomarker research will be sampled at baseline and after 3 or 6 months.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Deferred nephrectomyExperimental treatment 2 interventions
Group B: 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
Minimum 3 years follow-upSecondary outcomes
1
Progression free survival
According to the RECIST v1.1
Time frame
3 years follow-up2
Time to subsequent systemic therapy
Calculated from date of inclusion to date of initiation of subsequent therapy or death of any cause or censored at the date of last follow-up
Time frame
3 years follow-up3
Objective response rate
According to the RECIST v1.1
Time frame
3 years follow-up4
Rate of patients meeting randomization criteria
Compared with baseline values
Time frame
3 or 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Niels Fristrup
Lead sponsor
Aarhus University Hospital
Sponsor institution
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov