Trials / Completed
CompletedNCT03534804
Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma
Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma (PemCab)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- University of Utah · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open label, non-randomized phase 2 study of the combination of pembrolizumab and cabozantinib to assess overall response rate (ORR), progression free survival at 6 months (PFS6), and overall survival (OS) in patients with metastatic urothelial carcinoma (UC) ineligible for cisplatin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cabozantinib | Cabozantinib is administered at 40 mg oral daily |
| DRUG | Pembrolizumab | Pembrolizumab will be administered at a fixed dose of 200mg intravenously every 3 weeks. |
Timeline
- Start date
- 2018-09-18
- Primary completion
- 2023-08-02
- Completion
- 2024-04-15
- First posted
- 2018-05-23
- Last updated
- 2024-11-26
- Results posted
- 2024-11-26
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03534804. Inclusion in this directory is not an endorsement.