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Virus Therapy

Pembrolizumab + BCG for Bladder Cancer

Q: What infections does BCG help to immunize against?

<p>BCG is most commonly used to treat unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, but it can also be useful in managing microsatellite instability high, high risk of recurrence, and disease.</p>

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Following adequate BCG induction therapy, must have persistent or recurrent HR NMIBC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~3.5 years

Awards & highlights

Study Summary

This trial will compare the effectiveness of a combination of pembrolizumab and BCG to BCG monotherapy in treating people with high-risk, non-muscle invasive bladder cancer.

Who is the study for?

This trial is for adults with high-risk non-muscle invasive bladder cancer (HR NMIBC) that's persistent or recurrent after BCG therapy, or who haven't had BCG treatment. Participants need good organ function, must not be pregnant or breastfeeding, and agree to use contraception. Exclusions include active tuberculosis, recent other cancers, HIV infection, certain prior treatments including anti-PD-1/L1/L2 agents, and specific contraindications to BCG.Check my eligibility

What is being tested?

The study tests the effectiveness of pembrolizumab combined with BCG against BCG alone in HR NMIBC patients. It aims to see if the drug duo works better for complete response rate in those previously treated with BCG (Cohort A), and event-free survival in new patients (Cohort B).See study design

What are the potential side effects?

Pembrolizumab may cause immune-related side effects like inflammation of organs, skin reactions, hormone gland problems (like thyroid disorders), infusion reactions; as well as fatigue and infections. Side effects from BCG can include flu-like symptoms and irritation at the bladder site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My bladder cancer returned or persisted after BCG therapy.

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I've had surgery to remove bladder tumors.

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My bladder cancer is high-risk but has not invaded the muscle.

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I have completed a full course of BCG therapy for bladder cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~3.5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A)

Event-Free Survival (EFS) (Cohort B)

Secondary outcome measures

12-Month DOR Rate (Cohorts A and B)

12-Month EFS Rate (Cohort A)

24-Month EFS Rate (Cohort B)

+15 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: BCG plus Pembrolizumab: Post-induction Cohort A (Arm A-1)Experimental Treatment2 Interventions

Participants receive BCG (Induction and Maintenance) in combination with 200 mg pembrolizumab administered intravenously (IV) every 3 weeks (Q3W) for 35 doses (~2 years).

Group II: BCG plus Pembrolizumab: BCG Naïve Cohort B-Reduced Maintenance (Arm B-1)Experimental Treatment2 Interventions

Participants receive BCG (Induction and reduced Maintenance) in combination with 400 mg pembrolizumab administered IV every 6 weeks (Q6W) for 9 doses (~1 year).

Group III: BCG plus Pembrolizumab: BCG Naïve Cohort B-Full Maintenance (Arm B-2)Experimental Treatment2 Interventions

Participants receive BCG (Induction and full Maintenance) in combination with 400 mg pembrolizumab administered IV Q6W for 9 doses (~1 year).

Group IV: BCG Monotherapy: Post-induction Cohort A (Arm A-2)Experimental Treatment1 Intervention

Participants receive BCG monotherapy (Induction and Maintenance).

Group V: BCG Monotherapy: BCG Naïve Cohort B (Arm B-3)Experimental Treatment1 Intervention

Participants receive BCG monotherapy (Induction and Maintenance).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

BCG

2015

Completed Phase 4

~3220

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,580,878 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,888 Previous Clinical Trials

5,053,652 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,062,459 Total Patients Enrolled

Media Library

Bladder Cancer Clinical Trial 2023: BCG Highlights & Side Effects. Trial Name: NCT03711032 — Phase 3

Frequently Asked Questions

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

How often do patients experience negative side effects from BCG?

"BCG was given a safety score of 3, as it is a Phase 3 trial, meaning that there is strong evidence to support its efficacy, as well as safety from multiple rounds of testing."

Answered by AI

What infections does BCG help to immunize against?

"BCG is most commonly used to treat unresectable melanoma, but it can also be useful in managing microsatellite instability high, high risk of recurrence, and disease."

Answered by AI

Can anyone sign up for this test, or are there specific requirements?

"This is accurate. The online clinical trials registry does show that the study is still recruiting patients. The listing indicates that the trial was originally posted on December 24th, 2018 and was last edited on November 4th, 20212. The study is looking for 1405 participants from a total of 45 different sites."

Answered by AI

Do other research teams investigate BCG's effects?

"City of Hope first researched BCG in 2010. So far, there have been a total of 272 completed trials and 1006 active studies. A large portion of the ongoing research is taking place in Atlanta, GA."

Answered by AI

Could you please specify how many hospitals are testing this medication?

"Enrollment for this study is available at 45 different medical centres, which are situated in cities such as Atlanta, Lake Success and Orange, among others. If possible, patients should choose the location nearest to them to cut down on travel."

Answered by AI