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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 belowSelect...
My cancer was completely removed surgically.
Select...
I cannot or will not undergo major bladder surgery.
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I am willing to use birth control during the study.
Select...
My bladder cancer did not respond to BCG therapy despite adequate treatment.
Select...
I can provide a recent biopsy sample from a tumor that hasn't been treated with radiation.
Select...
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:Select...
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.
Select...
I have a lung condition not caused by an infection.
Select...
My bladder cancer is advanced and cannot be surgically removed.
Select...
I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks and have recovered from any side effects.
Select...
I have an active Hepatitis B or C infection.
Select...
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
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 moreSecondary study objectives
All Cohorts: Overall Survival (OS)
All Cohorts: Progression-Free Survival (PFS)
Cohort A and C: Duration of Response (DOR)
+8 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer was completely removed surgically.I have received a transplant from another person.I have no progressing cancer except skin cancer or treated in situ cervical or prostate cancer.I cannot or will not undergo major bladder surgery.I have been treated with drugs targeting immune checkpoints.I am a woman who can have children, not pregnant, and willing to use birth control.I am HIV positive.I have not received a live virus vaccine in the last 30 days.I am currently on medication for an infection.I am willing to use birth control during the study.My bladder cancer has spread to nearby areas but is not in the muscle.I have a lung condition not caused by an infection.My bladder cancer did not respond to BCG therapy despite adequate treatment.My organs are working well.My bladder cancer is advanced and cannot be surgically removed.I can provide a recent biopsy sample from a tumor that hasn't been treated with radiation.I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks and have recovered from any side effects.I've had bladder treatments between my last bladder exam and starting this study.I have an active Hepatitis B or C infection.I can take care of myself and am up and about more than half of my waking hours.I have been treated for an autoimmune disease in the last 2 years.My bladder cancer is high risk but has not spread into the muscle.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab
- Group 2: Pembrolizumab coformulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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