drugset / Trial / NCT05107427

Study of MRx0518 and Avelumab in Patients With Urothelial Carcinoma

NCT05107427 ↗

Phase 2 Withdrawn 4D pharma plc
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

EvaluationDrugModalityDoseRoute
Subject Avelumab Monoclonal antibody 800 mg Intravenous
Subject MRx0518 Other / unclassified — —

Indications