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Pembrolizumab + V940 for Bladder Cancer

Phase 1 & 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

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).

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adjuvant Cohort: Disease Free Survival (DFS)

Perioperative Cohort: Number of Participants Who Discontinue Study Treatment Due to AE

Perioperative Cohort: Number of Participants Who Experience an Adverse Event (AE)

Secondary study objectives

Adjuvant Cohort: Distant Metastasis-Free Survival (DMFS)

Adjuvant Cohort: Number of Participants Who Discontinue Study Treatment Due to an AE

Adjuvant Cohort: Number of Participants Who Experience an AE

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Perioperative Cohort: Pembrolizumab + V940 + EV and SurgeryExperimental Treatment4 Interventions

Participants will receive neoadjuvant treatment with up to 4 cycles of pembrolizumab plus EV and 1 to 4 doses of V940, followed by radical cystectomy \[RC\] plus pelvic lymph node dissection \[PLND\], and then adjuvant treatment with up to 13 cycles of pembrolizumab plus up to 5 cycles of EV and 5 to 8 doses of V940 (for a total of 9 neoadjuvant plus adjuvant V940 doses), or until any of the protocol-specified criteria for discontinuation of study intervention are met. The total duration of treatment is up to approximately 16 months.

Group II: Adjuvant Cohort: Pembrolizumab + V940Experimental Treatment2 Interventions

Adjuvant Cohort participants receive adjuvant treatment with up to 9 cycles of pembrolizumab plus up to a total of 9 doses of V940. V940 doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.

Group III: Adjuvant Cohort: Pembrolizumab + PlaceboActive Control2 Interventions

Adjuvant Cohort participants receive adjuvant treatment with up to 9 cycles of pembrolizumab plus up to a total of 9 doses of placebo. Placebo doses may begin as soon as Day 22 of Cycle 1. 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 3

~3130

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