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PD-1 Inhibitor

Pembrolizumab Combinations for Bladder Cancer

Q: How many participants have joined this clinical investigation so far?

<p>Merck Sharp &#x26; Dohme Corp. necessitates 320 participants that meet the criteria to carry out this trial, which will take place at two sites in <a href="https://www.withpower.com/clinical-trials/new-jersey">New jersey</a> and <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>: Call for Information (Investigational Site 0002) in Hackensack; and Call for Information (Investigational Site 0018) in New Brunswick.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 60 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

All Cohorts: Overall Survival (OS)

All Cohorts: Progression-Free Survival (PFS)

Cohort A and C: Duration of Response (DOR)

+8 more

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 2

~2010

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,963 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,888 Previous Clinical Trials

5,054,737 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,568 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pembrolizumab earned official endorsement from the Food and Drug Administration?

"The safety of Pembrolizumab is estimated at a 2 since it has only undergone Phase 2 trials, indicating that there are some indications of safety but no evidence to support efficacy."

Answered by AI

Are there additional investigations into Pembrolizumab's efficacy?

"Currently, the latest figures show that there are 916 active clinical trials examining Pembrolizumab with 122 of these studies in Phase 3. Although a significant amount of research is being carried out from Houston, Texas, an extensive network of 35860 medical sites across America conduct investigations related to this drug."

Answered by AI

Is there still an opportunity for individuals to join this scientific investigation?

"Per clinicaltrials.gov, this medical experiment is currently searching for participants. It was initially uploaded on February 10th 2016 and last modified on February 21st 2023."

Answered by AI

What conditions traditionally respond favorably to Pembrolizumab treatment?

"Pembrozulimab is a common medication used to combat malignant neoplasms. This drug can also be effectively utilized in the fight against unresectable melanoma, microsatellite instability high, and post-chemotherapy progression of disease."

Answered by AI

How many participants have joined this clinical investigation so far?

"Merck Sharp & Dohme Corp. necessitates 320 participants that meet the criteria to carry out this trial, which will take place at two sites in New jersey and New york: Call for Information (Investigational Site 0002) in Hackensack; and Call for Information (Investigational Site 0018) in New Brunswick."

Answered by AI

How many health care institutions are currently administering this trial?

"This study is being conducted out of Call for Information (Investigational Site 0002) in Hackensack, NJ, Call for Information (Investigational Site 0018) in New Brunswick, NY and Call for Information (Investigational Site 0076) situated Syracuse, OH just to name a few participating sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)

2016. "Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02625961.

All > South Carolina > New Jersey