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Study of MRx0518 and Avelumab in Patients With Urothelial Carcinoma

NCT05107427 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-04-18

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • 4D pharma plc

    lead INDUSTRY

Principal Investigators

  • Amishi Y Shah, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-04-30
Completion
2023-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05107427 on ClinicalTrials.gov