The Phase 3 trial investigating XL092 in combination with nivolumab for subjects with advanced or metastatic non-clear cell renal cell carcinoma (nccRCC) reached its primary completion on 2025-07-31. This study (NCT05678673) compares the combination therapy against sunitinib as a first-line treatment.
Background
The trial focuses on non-clear cell renal cell carcinoma (nccRCC), a less common form of kidney cancer. The study aims to evaluate a new treatment strategy for patients with unresectable, locally advanced, or metastatic nccRCC who have not previously received systemic anticancer therapy.
Trial design
The study, identified as NCT05678673, is a multicenter, randomized (2:1), open-label, controlled Phase 3 trial. It enrolled 317 subjects with unresectable, locally advanced, or metastatic non-clear cell renal cell carcinoma (nccRCC) who had not received prior systemic anticancer therapy. The trial evaluates XL092 in combination with nivolumab against sunitinib as the comparator arm.
What this means
The primary completion of this Phase 3 trial signifies that the main data collection period for the primary outcome measures has concluded. Researchers will now proceed with data analysis to determine the efficacy and safety profile of the XL092 and nivolumab combination compared to sunitinib in patients with advanced or metastatic non-clear cell renal cell carcinoma. The results are anticipated to provide crucial insights into potential new treatment options for this patient population.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT05678673, titled "Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma," was updated on 2025-07-31 on clinicaltrials.gov.