NCT03208712

Radium-223 and Atezolizumab in Patients With Urothelial Carcinoma With Bone Metastases Who Have Had Disease Progression After Platinum-Based Chemotherapy

Pilot Trial of Radium-223 and Atezolizumab in Patients With Urothelial Carcinoma With Bone Metastases Who Have Had Disease Progression After Platinum-Based Chemotherapy

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, single-site pilot of Radium-223 (55 kBq/kg) IV q3 weeks for up to 6 doses in combination with Atezolizumab 1200mg IV once every 3 weeks until investigator determined lack of benefit, unacceptable toxicity, or 17 doses in patients with urothelial carcinoma with bone metastases who have disease progression after platinum-containing chemotherapy.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab 1200 mg IV once every 3 weeks
DRUG	Radium-223	Radium- 223 IV (55 kBq/kg) every 3 weeks for up to 6 doses

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-08-02
• Completion: 2018-08-02
• First posted: 2017-07-05
• Last updated: 2018-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study