A phase 3 trial of Nivolumab in renal cell carcinoma, run by Bristol-Myers Squibb, active and no longer recruiting.
A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread is a phase 3 interventional study registered as NCT04810078 by Bristol-Myers Squibb, with 681 participants enrolled, started 2021-05-21 and due to reach its primary completion in 2025-07-29. Interventions recorded: Nivolumab and rHuPH20, Nivolumab. Conditions listed: Clear Cell Renal Cell Carcinoma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
681 enrolled.
90% CI 74.555 to 80.297; Figures from the ClinicalTrials.gov results section (first posted 2026-09-22), not from a publication · 90% CI 35.565 to 38.235 · 90% CI 70.941 to 80.361 · 90% CI 71.019 to 80.468
Source95% CI 19.0 to 30.0; Figures from the ClinicalTrials.gov results section (first posted 2026-09-22), not from a publication · 95% CI 13.6 to 23.6
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scaleprimary | Nivolumab SC | 242 | 77.373 μg/ml | - | - | link |
| Nivolumab IV | 245 | 36.875 μg/ml | ||||
| Nivo SC Process C | 93 | 75.504 μg/ml | ||||
| Nivo SC Process D | 93 | 75.596 μg/ml | ||||
| Objective Response Rate (ORR) Per BICR | Nivolumab SC | 248 | 24.2% | - | - | link |
| Nivolumab IV | 247 | 18.2% |
Shares Clear cell renal cell carcinoma, Bristol Myers Squibb, Renal cell carcinoma, Nivolumab.
Shares Bristol Myers Squibb, Renal cell carcinoma, Nivolumab, Immune checkpoint inhibitors.
Shares Bristol Myers Squibb, Nivolumab, Immune checkpoint inhibitors.
Shares Bristol Myers Squibb, Nivolumab, Immune checkpoint inhibitors.
Shares Bristol Myers Squibb, Nivolumab, Immune checkpoint inhibitors.
Shares Clear cell renal cell carcinoma, Renal cell carcinoma.
Shares Clear cell renal cell carcinoma, Renal cell carcinoma, Immune checkpoint inhibitors.
Shares Clear cell renal cell carcinoma, Renal cell carcinoma.