Study of MRx0518 and Avelumab in Patients With Urothelial Carcinoma — AVENU  

Urothelial Carcinoma Clinical Trial

Official title: A Phase 2 Switch Maintenance Study of MRx0518 and Avelumab in Patients With Unresectable Locally Advanced or Metastatic Urothelial Carcinoma Who Did Not Progress on First-Line Platinum-Containing Chemotherapy

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

Inclusion in the study must occur ≥4 but <10 weeks after the date of last dose of first-line chemotherapy. Post-chemotherapy confirmatory scan(s) for eligibility must be performed within 28 days prior to inclusion in the study to assess response status following first-line chemotherapy. Patients with ongoing partial response (PR) or stable disease (SD) (per RECIST v1.1) and who have measurable disease (per RECIST v1.1) are eligible for the study. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

• NCT number: NCT05107427
• Study type: Interventional
• Source: 4D pharma plc
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 1, 2022
• Completion date: April 2023