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PD-1 Inhibitor

Pembrolizumab Combinations for Bladder Cancer

Phase 2

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

Fully resected disease at study entry (residual CIS acceptable)

Ineligible for radical cystectomy or refusal of radical cystectomy

Must not have

Has had an allogeneic tissue/solid organ transplant

Prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a new therapy for people with bladder cancer that does not respond to Bacillus Calmette Guerin (BCG) therapy, who can't or won't have surgery. The goal is to see if this therapy produces a significant response.

Who is the study for?

This trial is for adults with high-risk bladder cancer that hasn't spread into the muscle, who didn't respond to BCG therapy and can't or won't have their bladder removed. They need good organ function, no recent other treatments or active infections, and must agree to use contraception.

What is being tested?

The study tests pembrolizumab alone or combined with other investigational drugs in patients whose bladder cancer remains after BCG treatment. The goal is to see if these therapies can effectively treat the cancer without surgery.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects like inflammation of organs, fatigue, skin reactions, digestive issues, hormone gland problems (like thyroid), and could worsen pre-existing conditions.

Eligibility Criteria

Inclusion Criteria

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

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My cancer was completely removed surgically.

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I cannot or will not undergo major bladder surgery.

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I am willing to use birth control during the study.

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My bladder cancer did not respond to BCG therapy despite adequate treatment.

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I can provide a recent biopsy sample from a tumor that hasn't been treated with radiation.

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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 is high risk but has not spread into the muscle.

Exclusion Criteria

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

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I have received a transplant from another person.

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I have been treated with drugs targeting immune checkpoints.

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I am HIV positive.

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I have not received a live virus vaccine in the last 30 days.

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I am currently on medication for an infection.

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My bladder cancer has spread to nearby areas but is not in the muscle.

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I have a lung condition not caused by an infection.

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My bladder cancer is advanced and cannot be surgically removed.

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I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks and have recovered from any side effects.

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I have an active Hepatitis B or C infection.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 60 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

All Cohorts: Number of Participants Who Discontinue Study Treatment Due to an AE

All Cohorts: Number of Participants Who Experience an Adverse Event (AE)

Cohort A: Complete Response (CR) Rate of High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC)

+2 more

Secondary study objectives

All Cohorts: Overall Survival (OS)

All Cohorts: Progression-Free Survival (PFS)

Cohort A and C: Duration of Response (DOR)

+8 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pembrolizumab coformulationExperimental Treatment2 Interventions

Participants with CIS with or without papillary tumors (Cohort C) will receive either pembrolizumab/vibostolimab or favezelimab/pembrolizumab coformulation intravenously Q3W for up to 24 months

Group II: PembrolizumabExperimental Treatment1 Intervention

Participants with carcinoma-in-situ (CIS) with or without papillary tumors (Cohort A) and participants with papillary tumors only, without CIS (Cohort B) will receive pembrolizumab, 200 mg, intravenously, every 3 weeks (Q3W) for up to 24 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 18Eligibility criteria met