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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 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
~2810

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,176 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,001 Previous Clinical Trials
5,184,591 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,881 Previous Clinical Trials
8,087,882 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02625961 — Phase 2
Bladder Cancer Research Study Groups: Pembrolizumab, Pembrolizumab coformulation
Bladder Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02625961 — Phase 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02625961 — Phase 2
~53 spots leftby Aug 2026