The Phase 3 study (NCT04810078) evaluating subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma reached its primary completion on 2025-07-29. This trial aims to assess drug levels, efficacy, safety, and tolerability of the subcutaneous formulation compared to the intravenous form.
Background
Nivolumab is an immunotherapy drug being investigated for its potential in various cancers. This particular Phase 3 study focuses on its application in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread.
Trial design
The study (NCT04810078) is a Phase 3 trial with an enrollment of 681 participants. It investigates subcutaneous nivolumab (formulated with rhuph20) against intravenous nivolumab in individuals with previously treated clear cell renal cell carcinoma that is advanced or has spread. The trial's purpose is to evaluate drug levels, efficacy, safety, and tolerability of the subcutaneous formulation, including a substudy on biocomparability of different manufacturing processes for subcutaneous nivolumab.
What this means
The primary completion of this Phase 3 trial indicates that the main data collection phase for comparing subcutaneous nivolumab to intravenous nivolumab in advanced clear cell renal cell carcinoma has concluded. The study's findings, once released, will provide crucial information on the potential for a subcutaneous formulation of nivolumab, which could offer a more convenient administration option for patients, pending demonstration of comparable efficacy and safety to the established intravenous therapy.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT04810078 was posted on 2025-07-29 on clinicaltrials.gov.