NCT05160285

Neoadjuvant Nivolumab for Upper Tract Urothelial Carcinoma

The NEVOLUTION Study: An Open Label, Single-arm, Phase II Study of Neoadjuvant Nivolumab in Locally Advanced Upper Tract Urothelial Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: YULISU · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to explore efficacy and safety of neoadjuvant nivolumab for non-metastatic upper tract urothelial carcinoma (UTUC), and explore the potential predictive biomarkers of immunotherapy.

Detailed description

Upper urinary tract urothelial carcinoma (UTUC) is a malignant tumor originated from the epithelium of upper urinary tract (renal pelvis and ureter). The standard treatment of UTUC is radical nephroureterectomy with ipsilateral bladder cuff excision. For locally advanced disease, neoadjuvant chemotherapy or adjuvant chemotherapy with radiotherapy is also a considerable treatment. In general, patients with UTUC are often diagnosed in a late stage with a poor survival. Nowadays, immune checkpoint inhibitor (ICI) emerged huge success in treatment of various type of cancers, including metastatic urothelial carcinoma. Several anti-PD1 or PD-L1 agents demonstrated an exciting response for metastatic urothelial carcinoma. The encouraging success makes clinical trials moving forward to neoadjuvant setting. In the PURE-01 study, patients with muscle-invasive bladder cancer received 3 cycles of neoadjuvant pembrolizumab achieving 39.5% pathological complete response (pCR). It brought a brand-new hope for organ-preservation treatment strategy. So far, neoadjuvant ICI has not been tested in patients with UTUC, irrespective for treatment efficacy or safety analysis. More importantly, there is still lack of reliable biomarkers to predict treatment response of ICI, which definitely an unmet medical need in clinical practice. Therefore, the investigators proposed a phase II, open-label study of neoadjuvant nivolumab in locally advanced UTUC. Investigators believe that neoadjuvant nivolumab will achieve at least similar pCR rate compared with neoadjuvant pembrolizumab in UCB patients. Furthermore, investigators will conduct a comprehensive exploratory genomic analysis to identify the potential candidate biomarkers to predict the response of nivolumab.

Conditions

• Upper Urinary Tract Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab 100 MG in 10 ML Injection	If you meet all the conditions to participate in the trial, you will receive the following treatments: Your physician will give you 360 mg of Nivolumab as an intravenous infusion every 3 weeks for about 30 minutes. For safety reasons, we recommend that you stay in the hospital for 60 minutes after the initial infusion of nivolumab. There will be a total of 3 cycles of Nivolumab treatments during the study period. You will need to return every 3 weeks. Each return will collect about 50 ml (10 tsp) of blood samples, depending on local standards.

Timeline

• Start date: 2020-12-25
• Primary completion: 2023-12-15
• Completion: 2024-12-30
• First posted: 2021-12-16
• Last updated: 2021-12-16

Locations

1 site across 1 country: Taiwan