NCT03557918

Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer

Phase 2 Trial of Tremelimumab in Patients With Metastatic Urothelial Cancer Previously Treated With PD-1/PD-L1 Blockade

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Matthew Galsky · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II trial designed to estimate the activity of single agent tremelimumab in subjects with metastatic urothelial cancer with disease progression despite prior treatment with PD-1/PD-L1 blockade. The primary endpoint is objective response rate and the study will employ a Simon's 2-stage design.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Tremelimumab	Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria.

Timeline

• Start date: 2018-11-12
• Primary completion: 2021-12-06
• Completion: 2023-06-07
• First posted: 2018-06-15
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study