NCT04066595

Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma.

Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma Who Have Progressed After Cisplatin-based Chemotherapy and Anti-PD-1/PD-L1 Therapy or After Anti-PD-1/PD-L1 Therapy Only.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Johannes Gutenberg University Mainz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this Phase II study we investigate the benefit of cabozantinib treatment for patients with locally advanced or metastasized urothelial cell carcinoma who have been pre-treated with checkpoint inhibitors only (cohort 1) or who have been pre-treated with cisplatin-based chemotherapy and checkpoint inhibitors (cohort 2). We are lacking adequate response and outcome data in patients after immunotherapy and consider that this study will improve future treatment modalities for this important patient cohort.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Cabozantinib	60 mg cabozantinib oral daily. When dose reduction is necessary, it is recommended to reduce to 40 mg daily, and then to 20 mg daily.

Timeline

• Start date: 2020-02-10
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2019-08-26
• Last updated: 2021-08-30

Locations

1 site across 1 country: Germany