NCT06586255

Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer

Phase I Safety Trial of Concurrent Adjuvant Immunotherapy and Radiation Therapy for the Treatment of Urothelial Bladder Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this Phase I study is to establish the safety of adjuvant concurrent immunotherapy and radiation therapy for urothelial bladder cancer.

Detailed description

Patients in this study will receive the standard of care procedures and follow-up for immunotherapy and radiation therapy. The part of this study that is research is receiving both of these treatments at the same time. Safety will be based on acute toxicity.

Conditions

• Urothelial Carcinoma Bladder
• Bladder Cancer

Interventions

Type	Name	Description
RADIATION	Concurrent Immunotherapy and Radiation Therapy	Radiation therapy will begin between 12 to 18 weeks from the start of adjuvant nivolumab. Patients will receive radiation therapy for about 6 weeks.

Timeline

• Start date: 2025-04-29
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2024-09-19
• Last updated: 2025-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study