drugset / Trial / NCT04289779
Study of CAbozantinib in Combination with AtezolizumaB for Muscle-Invasive BladdEr Cancer
Phase 2
Active not recruiting
46 enrolled
Deepak Kilari
Exelixis · collabGenentech, Inc. · collabMedical College of Wisconsin · collab
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label phase II study assessing the activity of cabozantinib combined with atezolizumab in patients with resectable muscle-invasive urothelial carcinoma who are ineligible for cisplatin-based therapy or decline cisplatin-based therapy. Each cycle equals 21 days. The dose of atezolizumab is 1200 mg IV flat dose every 3 weeks (Day 1) plus cabozantinib 40 mg orally daily (Day 1 through Day 21). Patients will receive three cycles of treatment prior to cystectomy unless they discontinue treatment for unacceptable toxicity or progressive disease by RECIST v1.1 or withdraw consent.
Timeline
- Start
- 2020-05-21
- Primary completion
- 2025-06
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | — |
| Subject | Cabozantinib | Small molecule | 40 mg | Oral |