Trial results for Nivolumab in patients with advanced renal cell carcinoma were posted on ClinicalTrials.gov on 2025-07-10. The Phase 2 study (NCT03117309) investigated nivolumab monotherapy and nivolumab plus ipilimumab, revealing varying 1-year progression-free survival (PFS) rates and objective response rates (ORR) across different cohorts.
Background
Nivolumab is an immunotherapy drug. The trial investigated its use in advanced renal cell carcinoma (RCC), a type of kidney cancer. The study specifically included treatment-naïve patients with clear cell RCC (ccRCC) and patients with non-clear cell RCC (nccRCC).
Trial design
The study, NCT03117309, was a Phase 2 trial titled "Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma." It enrolled 164 participants with advanced renal cell carcinoma. The trial investigated different treatment regimens, including nivolumab monotherapy and combination therapy with nivolumab and ipilimumab. The study included cohorts for clear cell RCC (ccRCC) and non-clear cell RCC (nccRCC).
Key results
Key results were reported for different cohorts within the study:
- For "1-year Progression Free Survival (PFS) Rate for ccRCC Patients" in "Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC", observed rates included 34.6%, 53.8%, 33.3%, and 75% of participants.
- For "Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy" in "Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC", observed rates included 26.9%, 53.8%, 33.3%, and 75% of participants.
- For "Objective Response Rate (ORR) for ccRCC Patients Treated With Nivolumab and Ipilimumab" in "Cohort A Part B: Nivolumab and Ipilimumab in Clear Cell RCC", observed rates included 7.7%, 66.7%, and 0% of participants.
- For "Clinical Activity for nccRCC Patients" in "Cohort B Part A: Nivolumab Monotherapy in Non Clear Cell RCC", an observed rate of 60% of participants was reported.
What this means
The posted trial results for Nivolumab in advanced renal cell carcinoma demonstrate a range of clinical activities and response rates across the investigated cohorts. The observed variability in 1-year PFS and ORR for ccRCC patients treated with nivolumab monotherapy, as well as the ORR for those receiving nivolumab and ipilimumab, suggests diverse patient responses. The 60% clinical activity observed in nccRCC patients treated with nivolumab monotherapy indicates potential benefit in this subgroup. These findings contribute to the understanding of nivolumab's efficacy profile in different advanced RCC populations.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03117309, titled "Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma," were posted on 2025-07-10 on clinicaltrials.gov.