A Phase 3 clinical trial for Nivolumab (NCT02632409) reached its primary completion on 2020-07-17, demonstrating extended disease-free survival in patients with bladder or upper urinary tract cancer following surgery. The study showed that patients treated with Nivolumab had a median disease-free survival of 20.76 months, compared to 10.84 months for those receiving placebo.
Background
Nivolumab is an immunotherapy investigated for its role in treating various advanced cancers. This particular study focused on its use in patients who had undergone radical surgery for invasive urothelial cancer, which includes bladder or upper urinary tract cancer.
Trial design
The study, identified as NCT02632409, was a Phase 3, randomized, placebo-controlled trial. It enrolled 709 participants who had undergone radical surgery for invasive urothelial cancer, encompassing bladder or upper urinary tract cancer. Participants were randomized to receive either Nivolumab or a placebo to determine the effectiveness and safety of the investigational immunotherapy.
Key results
The trial's primary completion revealed significant findings regarding disease-free survival (DFS). For the overall population, median DFS was 20.76 months for patients treated with Nivolumab, compared to 10.84 months for the placebo group. A stratified Cox Proportional hazard model showed a hazard ratio (HR) of 0.7 (98.22% Confidence Interval: 0.55 to 0.9) with a p-value of 0.0008, indicating a statistically significant reduction in the risk of disease recurrence or death with Nivolumab.
Regarding non-urothelial tract recurrence-free survival, the median was 22.93 months for Nivolumab and 13.70 months for placebo. Another stratified Cox Proportional hazard model yielded an HR of 0.54 (98.72% Confidence Interval: 0.35 to 0.84) with a p-value of 0.0005, further supporting the benefit of Nivolumab in preventing recurrence outside the urinary tract.
In the subgroup of patients with PD-L1 expression ≥ 1%, median DFS for the placebo group was 8.41 months, while the median for Nivolumab in this subgroup was not available. Similarly, for non-urothelial tract recurrence-free survival in the PD-L1 expression ≥ 1% population, the median for placebo was 10.84 months, with the Nivolumab median not available.
What this means
The results from this Phase 3 trial suggest that Nivolumab could offer a significant benefit in extending disease-free survival for patients with bladder or upper urinary tract cancer following radical surgery. The observed improvement in median DFS and non-urothelial tract recurrence-free survival, coupled with statistically significant hazard ratios, indicates a potential role for Nivolumab as an adjuvant therapy in this patient population. These findings could inform future treatment guidelines and provide a new therapeutic option to reduce the risk of recurrence after surgery.
Source
This information is based on the primary completion data from the clinical trial NCT02632409, as reported on ClinicalTrials.gov on 2020-07-17. The full study details are available on clinicaltrials.gov.