NCT05600127

Chemotherapy and Sequential Immunotherapy for Locally Advanced Urothelial Cancer

Chemotherapy and Sequential Immunotherapy for Locally Advanced Urothelial Cancer: the CHASIT Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with locally advanced or clinically node positive urothelial carcinoma treated with chemotherapy, will receive 3 cycles of avelumab, followed by radical surgery.

Detailed description

Patients with locally advanced or clinically node positive urothelial carcinoma of the bladder, ureter or urethra (cT4NxM0 or cTxN1-N3M0) with at least stable disease after treatment with 3-4 cycles of platinum-based chemotherapy, will be treated with 3 cycles of avelumab (anti-PD-L1). If there are no signs of disease progression after avelumab treatment, radical surgery of the primary tumor and a pelvic lymph node dissection will follow.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Avelumab	3 cycles of avelumab (800mg, every 2 weeks)

Timeline

• Start date: 2022-12-01
• Primary completion: 2025-04-01
• Completion: 2026-12-01
• First posted: 2022-10-31
• Last updated: 2023-09-08

Locations

4 sites across 1 country: Netherlands