Nivolumab SC results show higher response rate in kidney cancer

ClinicalTrials.gov posted results on 22 September 2026 for a Phase 3 study comparing subcutaneous (SC) with intravenous (IV) nivolumab in previously treated advanced or metastatic clear cell renal cell carcinoma. The reported objective response rate was 24.2% with SC nivolumab and 18.2% with IV nivolumab.

Background

The study evaluated nivolumab in participants with clear cell renal cell carcinoma that had been previously treated and was advanced or had spread. The registry summary says the trial assessed drug levels, efficacy, safety, and tolerability. It also included a substudy comparing drug levels for SC nivolumab made using two manufacturing processes. The supplied record does not provide information about the drug’s mechanism, prior approvals, or disease prevalence.

Trial design

This Phase 3 study enrolled 681 participants and remains listed as active, not recruiting. Its interventions were SC nivolumab with rhuph20 and IV nivolumab. The registry lists no primary-outcome entries. Posted measurements included nivolumab serum concentrations and objective response rate assessed per BICR; the record does not define that assessment method in the supplied data.

Key results

Objective response rate was 24.2% with SC nivolumab and 18.2% with IV nivolumab. The registry labels these results with 95% confidence intervals but supplies no interval values. The adjusted geometric mean serum concentration over 28 days was 77.373 μg/mL for SC nivolumab and 36.875 μg/mL for IV nivolumab; the record labels a 90% confidence interval but provides no interval values. Steady-state trough concentration was 122.227 μg/mL with SC treatment and 68.901 μg/mL with IV treatment. No p-values were reported in the supplied data.

What this means

The posted measurements show higher observed response and serum concentration values in the SC group than in the IV group. However, the supplied record does not include confidence-interval values, p-values, adverse-event summaries, or primary-outcome entries. These omissions limit assessment of the precision and statistical significance of the comparison and do not support conclusions about comparative safety.

Source

Source: ClinicalTrials.gov, registry results for “A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread,” posted 22 September 2026. Available at clinicaltrials.gov/study/NCT04810078.