NCT04871594

Pre-operative Immunotherapy in Stage II-III Urothelial Cancer

A Phase 1b Trial in Stage II-III Urothelial Cancer to Explore Pre-operative Immunotherapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1b feasibility study of pre-operative immunotherapy in PD-L1 positive resectable stage II-III urothelial cancer patients. This study can be adapted or expanded based on the results obtained.

Detailed description

This is a phase 1b feasibility study of pre-operative immunotherapy in PD-L1 positive resectable stage II-III urothelial cancer patients. Urothelial cancer patients will be included that are diagnosed with either: * cT2-4aN0M0 OR * cT1-4aN1-3M0 PD-L1 status will be determined. When PD-L1 CPS is ≥10%, patients will be treated with three cycles nivolumab 240 mg, q3wk, on day 1, 22, 43. The primary endpoint is feasibility of pre-operative nivolumab in PD-L1 positive resectable stage II-III urothelial cancer patients. After surgery, patients attend study visits at day 8 and at day 29. Their final study visit for physical examination and laboratory testing is at day 57 (+/- 7 days), which is scheduled to anticipate late-onset adverse events. 90 days postoperative, surgical complications according to the Clavien-dindo classification will be evaluated. Thereafter, patients will be followed according to standard clinical guidelines. Tumor biopsies/material preservation is required at baseline and during surgery. Main secondary endpoints are: * To identify pathological complete response rates of nivolumab in PD-L1 positive resectable stage II-III urothelial cancer patients * To describe immune-related grade 3/4 and all grade toxicities * To describe RFS and OS * Translational: Effects of immunotherapy on the tumor microenvironment based on RNA signatures and changes in immune infiltrates between baseline and resection.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	On day 1, 22, and 43 240mg

Timeline

• Start date: 2021-08-23
• Primary completion: 2023-06-02
• Completion: 2024-12-30
• First posted: 2021-05-04
• Last updated: 2025-03-05

Locations

2 sites across 1 country: Netherlands