NCT05687721

Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer

A Phase II Trial With Copanlisib Plus Avelumab as a Maintenance Therapy for Metastatic Bladder Cancer After Platinum-based Chemotherapy

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with metastatic bladder cancer are usually treated with chemotherapy. If their cancers do not progress after chemotherapy, they can be enrolled into this study and receive a standard-of-care immunotherapy medication named avelumab plus a study drug named copanlisib.

Detailed description

Patients with advanced urothelial cancer will be treated with platinum-based chemotherapy. After chemotherapy, an imaging study will be performed to determine cancer response. If there is no disease progression, patients will be eligible for this study. After informed consent is obtained, patients are enrolled. The treatment include immunotherapy avelumab as the standard of care plus a study medication copanlisib. Both medications are administrated through intravenous infusion. Avelumab wil be given once every two weeks while copanlisib will be administrated on Day 1, 8 and 15 of every 4-week cycle. Patient will be followed up for disease progression.

Conditions

• Advanced Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	copanlisib	intravenous infusion (IV) at 60 mg on Day 1, 8 and 15 of each 4-week treatment cycle for up to 26 cycles
DRUG	Avelumab	800 mg intravenous infusion on Day 1 and 15 of each 4-week treatment cycle for up to 26 cycles

Timeline

• Start date: 2025-06-02
• Primary completion: 2025-06-02
• Completion: 2025-06-02
• First posted: 2023-01-18
• Last updated: 2025-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study