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Virus Therapy

Pembrolizumab + BCG for Bladder Cancer

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

Must not have

Has an active infection or diagnosis requiring systemic antimicrobial therapy

Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~3.5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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).

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for an infection.

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I have or had lung inflammation that needed steroids.

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I have been treated for an autoimmune disease in the last 2 years.

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My bladder cancer remains after BCG treatment.

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My bladder cancer is advanced or has spread to other parts.

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I have a history of Hepatitis B or an active Hepatitis C infection.

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I have been treated with drugs targeting immune checkpoints.

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I cannot receive BCG due to past severe reactions or specific health issues.

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I have received an organ or tissue transplant from another person.

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I cannot have imaging tests with IV contrast due to health reasons.

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I currently have active tuberculosis.

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I have or had bladder cancer that has not spread to my muscles.

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

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

Primary study objectives

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

Event-Free Survival (EFS) (Cohort B)

Secondary study objectives

12-Month DOR Rate (Cohorts A and B)

12-Month EFS Rate (Cohort A)

24-Month EFS Rate (Cohort B)

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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