ClinicalTrials.gov recorded primary completion on 12 February 2020 for a Phase 3 trial of nivolumab combined with cabozantinib in previously untreated advanced or metastatic renal cell carcinoma. Median progression-free survival was 16.59 months in Treatment A and 8.31 months in Treatment C, while the study enrolled 701 participants.

Background

The study evaluated nivolumab combined with cabozantinib against sunitinib in people with previously untreated advanced or metastatic renal cell carcinoma. The registered interventions were nivolumab, cabozantinib, sunitinib, and ipilimumab. The trial’s stated purpose was to assess whether the nivolumab and cabozantinib combination was safe and effective compared with sunitinib.

Trial design

This was a completed Phase 3 study involving 701 participants with renal cell carcinoma. The registry lists Treatment A, Treatment B, and Treatment C in its outcome measurements, but the supplied record does not identify each treatment label’s corresponding regimen. Reported outcomes included progression-free survival, overall survival, objective response rate, and adverse events. No primary outcome entries were supplied in the data block.

Key results

For progression-free survival, the registry reported a median of 16.59 months for Treatment A and 8.31 months for Treatment C. The supplied analyses included a hazard ratio of 0.51 with a 95% confidence interval of 0.41 to 0.64 and p=0.0001. A second analysis reported a hazard ratio of 0.60, a 98.89% confidence interval of 0.40 to 0.89, and p=0.001.

  • Objective response rate was 55.7% in Treatment A, 44.0% in Treatment B, and 27.1% in Treatment C.
  • The supplied odds-ratio analysis reported 3.52, with a 95% confidence interval of 2.51 to 4.95 and p=0.0001.
  • The reported difference in objective response rates was 28.6 percentage points, with a 95% confidence interval of 21.7 to 35.6.
  • Overall-survival medians were listed as NA for Treatments A and C.
  • Adverse events were reported for 319 participants in Treatment A, 50 participants in Treatment B, and 317 participants in Treatment C. Serious adverse events were reported for 160 participants in Treatment A and 28 participants in Treatment B.

What this means

The completed trial record reports longer median progression-free survival and higher objective response rates for Treatment A than Treatment C, alongside statistically reported hazard-ratio and response-rate analyses. Because the supplied data do not map Treatment A, B, and C to specific regimens, the findings cannot be attributed more precisely to an individual treatment comparison here. The record also does not provide overall-survival medians beyond “NA” for the listed groups or a complete adverse-event summary.

Source

Source: ClinicalTrials.gov, trial primary-completion and results record for NCT03141177, dated 12 February 2020. The registry record is available at clinicaltrials.gov/study/NCT03141177.