drugset / Trial / NCT04477512
Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial)
Phase 1
Completed
18 enrolled
Washington University School of Medicine
Bristol-Myers Squibb · collabExelixis · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The goal of this study is to determine the recommended phase 2 dose of the multi-drug combination of abiraterone, cabozantinib, and nivolumab in conjunction with ongoing androgen deprivation therapy in previously untreated metastatic hormone-sensitive prostate cancer patients. The investigators hypothesize that the combination of cabozantinib and abiraterone acetate/prednisone in conjunction with nivolumab will have an acceptable safety profile and will be feasible to administer in patients with hormone-sensitive metastatic prostate cancer.
Timeline
- Start
- 2021-02-19
- Primary completion
- 2021-09-09
- Completion
- 2025-09-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabozantinib | Small molecule | 20 mg | Oral |
| Subject | Cabozantinib | Small molecule | 40 mg | Oral |
| Background | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Background | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |