drugset / Trial / NCT05107427
Study of MRx0518 and Avelumab in Patients With Urothelial Carcinoma
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, switch maintenance study of MRx0518 and Avelumab in patients with unresectable locally advanced or metastatic urothelial carcinoma (UC) whose disease did not progress after 4 to 6 cycles of first-line platinum-containing chemotherapy and who have residual measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Up to 30 patients will be enrolled. Patients enrolled in this study will be treated with IV Avelumab every 2 weeks and MRx0518 daily during the treatment period. Patients will receive the study treatment until disease progression (PD), patient withdrawal, or unacceptable toxicity.
Timeline
- Start
- 2022-03-01
- Primary completion
- 2023-04
- Completion
- 2023-04
Outcome
Outcome not reported
Stopped: “Sponsor unable to proceed”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | 800 mg | Intravenous |
| Subject | MRx0518 | Other / unclassified | — | — |