drugset / Trial / NCT03606174
A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The study will evaluate the clinical activity of PD-(L)1 Checkpoint Inhibitor regimens in combination with the investigational agent sitravatinib in patients with advanced or metastatic urothelial carcinoma.
Timeline
- Start
- 2018-09-11
- Primary completion
- 2022-08-03
- Completion
- 2022-08-22
Outcome
Outcome not reported
Stopped (Business): “The study was terminated due to sponsor decision / portfolio prioritization, and not due to safety reasons.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enfortumab Vedotin | Other / unclassified | 1 mg/kg | Intravenous |
| Subject | Enfortumab Vedotin | Other / unclassified | 1.25 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Sitravatinib | Small molecule | 35 mg | Oral |
| Subject | Sitravatinib | Small molecule | 50 mg | Oral |
| Subject | Sitravatinib | Small molecule | 70 mg | Oral |
| Subject | Sitravatinib | Small molecule | 100 mg | Oral |
| Subject | Sitravatinib | Small molecule | 120 mg | Oral |