NCT05107427

Study of MRx0518 and Avelumab in Patients With Urothelial Carcinoma

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• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: 4D pharma plc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	MRx0518	MRx0518 is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The study dosing regimen is one capsule two times per day for the duration of the treatment period.
BIOLOGICAL	Avelumab 20 mg/mL Intravenous Solution (IV)	Avelumab is an IV administered monoclonal antibody that blocks the interaction of programmed death ligand-1 (PD-L1) with its receptors PD-1 and B7.1 on T cells and antigen-presenting cells, and has been shown to activate adaptive and innate immune functions. The study dosing regimen is 800 mg (four 20mL vials of 20mg/mL solution) for IV infusion once every two weeks

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2021-11-04
• Last updated: 2023-04-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study