NCT05107427: AVENU

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

Withdrawn Phase 2 Last updated 14 April 2023

What this trial tests

Phase 2 trial testing MRx0518 in Urothelial Carcinoma. Withdrawn.

Timeline

1 March 2022

Primary endpoint
1 April 2023

1 April 2023

Quick facts

Lead sponsor	4D pharma plc
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 March 2022
Primary completion	1 April 2023
Estimated completion	1 April 2023
Sites	3 locations across United States

Drugs / interventions tested

• MRx0518 — full drug profile →
• Avelumab 20 mg/mL Intravenous Solution (IV) — full drug profile →

Conditions studied

• Urothelial Carcinoma — all drugs for Urothelial Carcinoma →

Sponsor

4D pharma plc — full company profile →

Who can join

18 and older, any sex, with Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety of MRx0518 and Avelumab combination treatment
  Time frame: Through study completion, an average of 1 year
  Safety of MRx0518 and Avelumab combination treatment assessed by adverse events (AEs) as graded by National Cancer Institute (NCI) Common Terminology (CTCAE V5.0)
• Landmark PFS at 6 months from the date of first dose of study treatment for all patients
  Time frame: All patients after 6 months
  Landmark PFS at 6 months from the date of first dose of study treatment for all patients. PFS events are death due to any cause or PD as determined by the investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut microbiota influence immunotherapy responses: mechanisms and therapeutic strategies.
   Lu Y, Yuan X, Wang M, He Z, et al · · 2022 · cited 360× · PMID 35488243 · DOI 10.1186/s13045-022-01273-9
2. Microbial mechanisms to improve immune checkpoint blockade responsiveness.
   Griffin ME, Hang HC. · · 2022 · cited 15× · PMID 35816968 · DOI 10.1016/j.neo.2022.100818
3. Commensal Microbiota and Cancer Immunotherapy: Harnessing Commensal Bacteria for Cancer Therapy.
   Bae J, Park K, Kim YM. · · 2022 · cited 14× · PMID 35291651 · DOI 10.4110/in.2022.22.e3
4. A Comprehensive Review of Immunotherapy Clinical Trials for Metastatic Urothelial Carcinoma: Immune Checkpoint Inhibitors Alone or in Combination, Novel Antibodies, Cellular Therapies, and Vaccines.
   Patel DM, Mateen R, Qaddour N, Carrillo A, et al · · 2024 · cited 13× · PMID 38254823 · DOI 10.3390/cancers16020335
5. Microbiota and their metabolites potentiate cancer immunotherapy: Therapeutic target or resource for small molecule drug discovery?
   Du P, Jing J, He X. · · 2022 · cited 6× · PMID 36588712 · DOI 10.3389/fphar.2022.1091124
6. Current status and future perspectives of multi-modal bacteria-based cancer therapies.
   Fan S, Zhu S, Wang W, Liu Y, et al · · 2025 · cited 1× · PMID 41121752 · DOI 10.1002/ctm2.70485
7. Switch Maintenance Therapy for Metastatic Urothelial Carcinoma.
   Ahmed R, Gupta S. · · 2022 · PMID 38994180 · DOI 10.3233/blc-220030