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Pembrolizumab + V940 for Bladder Cancer

Phase 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

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 up to approximately 28 months

Awards & highlights

Study Summary

This trial aims to test if a drug called V940, when given with pembrolizumab, is safer and more effective than pembrolizumab alone in treating individuals with a specific type

Who is the study for?

This trial is for individuals with high-risk muscle-invasive bladder cancer who've had surgery to remove it. Participants must be able to provide blood samples, have their tumor DNA tested, and give a tissue sample for genetic sequencing. They should also be relatively active and mobile (ECOG status 0-2).Check my eligibility

What is being tested?

The study is testing the effectiveness of a vaccine called V940 when given with Pembrolizumab versus Pembrolizumab alone in preventing cancer return after surgery. The goal is to see if adding V940 improves disease-free survival.See study design

What are the potential side effects?

Pembrolizumab can cause immune system reactions affecting organs, fatigue, skin rash, diarrhea, and infusion-related reactions. Side effects specific to V940 are not detailed but may include typical vaccine-related responses like soreness or fever.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 28 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 28 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 28 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease Free Survival (DFS)

Secondary outcome measures

Distant Metastasis-Free Survival (DMFS)

Number of Participants Who Discontinue Study Treatment Due to an AE

Number of Participants Who Experience an Adverse Event (AE)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab + V940Experimental Treatment2 Interventions

Participants receive 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of every 6-week cycle for up to 9 cycles, plus 1 mg of V940 via intramuscular (IM) injection once available every 3 weeks up to a total of 9 doses. V940 doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.

Group II: Pembrolizumab + PlaceboActive Control2 Interventions

Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 6-week cycle for up to 9 cycles. Placebo will be administered every 3 weeks up to a total of 9 doses. The total duration of treatment is up to approximately 13 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Industry Sponsor

108 Previous Clinical Trials

61,379,117 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,060,946 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,064,204 Total Patients Enrolled

Frequently Asked Questions

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

Is this medical study actively seeking participants at the moment?

"According to the details found on clinicaltrials.gov, this investigation is presently enrolling participants. The trial's initial posting date was 28th March 2024 and its most recent update was on 5th April 2024."

Answered by AI

How many individuals are currently enrolled in this medical research study?

"Indeed, the information available on clinicaltrials.gov highlights that this investigation is presently seeking suitable candidates. The trial was initially disclosed on March 28th, 2024 and underwent its most recent revision on April 5th, 2024. A total of 200 individuals are being sought to participate in this study across two designated sites."

Answered by AI

Has the combination of Pembrolizumab and V940 received official approval from the FDA?

"According to our evaluation at Power, the safety rating for Pembrolizumab + V940 is 2 on a scale of 1 to 3. This assessment aligns with being in Phase 2 where there exists some data indicating safety but not efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005)

2024. "A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06305767.

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