Condition: Kidney Cancer · Renal Cell Carcinoma Metastatic · Synchronous Neoplasm · Sponsor: Niels Fristrup
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.
This description comes directly from the study's public registry record.
Niels Fristrup, MD PhD · 004520914161 · niels.fristrup@rm.dk
Ane Iversen, MD PhD · ANEIVE@rm.dk
Always discuss trial participation with your own doctor first.
| 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 |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT03977571