Pembrolizumab + BCG for Bladder Cancer

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. The goals of this study are to learn: 1. If more people who receive pembrolizumab with Bacillus Calmette-Guerin (BCG) have no signs of cancer in their body and live longer without the cancer growing, spreading, or coming back compared to people who receive BCG alone. 2. About the safety and how well people tolerate BCG alone or in combination with pembrolizumab.

Eligibility Criteria

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.

Inclusion Criteria

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

My bladder cancer returned or persisted after BCG therapy.

I've had surgery to remove bladder tumors.

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

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

Exclusion Criteria

I am currently on medication for an infection.

I have or had lung inflammation that needed steroids.

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

My bladder cancer remains after BCG treatment.

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

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

I have been treated with drugs targeting immune checkpoints.

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

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

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

I currently have active tuberculosis.

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

Treatment Details

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).

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).

BCG is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Bacillus Calmette-Guérin for: