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Monoclonal Antibodies

MRx0518 for Bladder Cancer (AVENU Trial)

Phase 2
Waitlist Available
Led By Amishi Y Shah, MD
Research Sponsored by 4D pharma plc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

AVENU Trial Summary

This trial is testing a new immunotherapy treatment for patients with urothelial carcinoma that has not progressed after first-line chemotherapy. The treatment consists of two drugs given intravenously.

Eligible Conditions
  • Bladder Cancer

AVENU Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Landmark PFS at 6 months from the date of first dose of study treatment for all patients
Safety of MRx0518 and Avelumab combination treatment
Secondary outcome measures
Disease Control Rate (DCR)
Objective progressive disease (PD)
Objective response rate (ORR)
+3 more

AVENU Trial Design

1Treatment groups
Experimental Treatment
Group I: MRx0518 + AvelumabExperimental Treatment2 Interventions
Subjects will receive 1 capsule of MRx0518 BID throughout the treatment period and IV infusion of Avelumab every 2 weeks in 4-week cycles

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Who is running the clinical trial?

4D pharma plcLead Sponsor
8 Previous Clinical Trials
614 Total Patients Enrolled
Amishi Y Shah, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Avelumab 20 mg/mL Intravenous Solution (IV) a secure option for patients?

"Our team at Power placed Avelumab 20 mg/mL Intravenous Solution (IV) on the safety scale with a 2 rating, as phase two trials have generated some evidence of its security, yet not any that corroborates efficacy."

Answered by AI

Is this a pioneering clinical trial?

"Research surrounding Avelumab 20 mg/mL Intravenous Solution (IV) dates back to 2014 when it was sponsored by EMD Serono Research & Development Institute, Inc. In that year the inaugural trial concluded with 204 participants and earned its Phase 2 approval. Today, this drug is being tested in a total of 112 trials spanning 1024 cities across 52 nations."

Answered by AI

Have there ever been investigations that focused on the effects of Avelumab 20 mg/mL Intravenous Solution (IV)?

"Currently, 112 clinical trials are being conducted on Avelumab 20 mg/mL Intravenous Solution (IV), 10 of which have progressed to Phase 3. Barcelona, South dakota is the main hub for these studies; nonetheless, there are 3685 sites around the world running tests with this medication."

Answered by AI

How many participants are being recruited for this investigation?

"Unfortunately, this specific trial is not currently in search of participants. It was posted on March 1st 2022 and last revised July 5th 2022. However, there are 2515 trials related to transitional cell carcinoma presently open for recruitment as well as 112 clinical studies involving Avelumab 20 mg/mL Intravenous Solution (IV)."

Answered by AI

What objectives is this medical trial looking to accomplish?

"This clinical trial aims to evaluate the safety of MRx0518 and Avelumab combination treatment over a 6-month period. Secondary objectives include measuring objective progressive disease (PD) duration, progression-free survival (PFS), as well as time to response from first dose until confirmed tumor response."

Answered by AI

Is recruitment for this research endeavor currently underway?

"According to clinicaltrials.gov, recruitment for this study has been suspended since July 5th 2022; however, there are still 2,627 other medical trials actively recruiting patients at the current moment."

Answered by AI
~0 spots leftby Apr 2025