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Alkylating agents
Pembrolizumab + Chemoradiotherapy for Bladder Cancer
Phase 3
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
Has a histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 1 year
Awards & highlights
Study Summary
This trial will compare the effectiveness of a new cancer treatment (pembrolizumab + chemoradiotherapy) to the current standard of care (chemoradiotherapy alone) for people with muscle-invasive bladder cancer.
Who is the study for?
This trial is for adults with muscle-invasive bladder cancer who are set to receive chemoradiotherapy and meet certain health criteria, including good organ function and performance status. Women must not be pregnant or breastfeeding and follow specific contraceptive guidelines; men must agree to use contraception or abstain from heterosexual intercourse.Check my eligibility
What is being tested?
The study tests the effectiveness of pembrolizumab (a type of immunotherapy) combined with chemoradiotherapy versus just chemoradiotherapy in treating bladder cancer. The goal is to see if adding pembrolizumab improves survival without the cancer spreading or worsening.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs, infusion reactions, fatigue, skin rash, digestive issues like diarrhea, liver problems, hormone gland issues (like thyroid), and can increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bladder cancer was confirmed to be invasive and mainly urothelial.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am scheduled for chemoradiotherapy with a specific chemotherapy plan.
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My bladder cancer has not spread to other parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bladder Intact Event-Free Survival (BI-EFS)
Secondary outcome measures
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Change from Baseline in Urinary, Bowel, and Sexual Domains of the Bladder Cancer Index (BCI)
Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
+11 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pembrolizumab + Chemotherapy + RadiotherapyExperimental Treatment8 Interventions
Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Group II: Placebo + Chemotherapy + RadiotherapyPlacebo Group8 Interventions
Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Cisplatin
2013
Completed Phase 3
~1940
Fluorouracil (5-FU)
2014
Completed Phase 2
~300
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,499 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,035 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,108 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.I have an autoimmune disease treated with medication in the last 2 years.You have a severe allergy to the specific treatments or any of their ingredients.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.My bladder cancer was confirmed to be invasive and mainly urothelial.I have had or currently have lung inflammation treated with steroids.I can take care of myself and am up and about more than half of my waking hours.I have received treatment with specific medications before.I am scheduled for chemoradiotherapy with a specific chemotherapy plan.I have received an organ or tissue transplant from another person.I am a male who agrees not to donate sperm and will either abstain from sex or use contraception.You have been diagnosed with HIV.I have had urothelial cancer outside the bladder, but not in the upper tract unless removed by surgery.My bladder cancer is widespread but not invasive.I have swelling in both kidneys due to urine buildup.I am currently being treated for an infection with medication.I am not pregnant or breastfeeding and follow the required contraceptive guidelines.I have not received a live vaccine in the last 30 days.I have an active tuberculosis infection.I have another cancer besides the one being studied, but it hasn't needed treatment in the last 3 years.My bladder cancer has not spread to other parts of my body.I have trouble with bladder control or function.I have had radiation or cancer treatment for bladder cancer.I have a history of hepatitis B or an active hepatitis C infection.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Chemotherapy + Radiotherapy
- Group 2: Placebo + Chemotherapy + Radiotherapy
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please list other medical trials that have used Pembrolizumab?
"Pembrolizumab was first researched in 1997 by the City of Hope Comprehensive Cancer Center. 2327 trials have completed since then, with 2131 more underway as of now. Many of these active studies are based out of Milwaukee, Wisconsin."
Answered by AI
Has Pembrolizumab been federally recognized in the United States?
"Pembrolizumab falls into the third phase of clinical trials, which means that there is both efficacy and safety data available. Our team has given it a score of 3 out of 3."
Answered by AI
Do we still need participants for this experiment?
"According to the clinicaltrials.gov website, this trial is still looking for 636 participants at 14 different locations. The listing was first posted on May 19th, 2020 and updated as recently as October 20th, 2020."
Answered by AI
How many people are currently signed up to participate in this experiment?
"This clinical trial needs 636 participants who meet the eligibility requirements. Those who take part in this study can do so at Froedtert and Medical College of Wisconsin ( Site 0022) in Milwaukee, Wisconsin or West virginia University - Charleston Area Medical Center ( Site 6003) in Charleston, West Virginia."
Answered by AI
What is Pembrolizumab's principle area of application?
"Pembrolizumab can be used to fight malignant melanoma of the skin, recurrent cervical cancer, and refractory, relapsed mediastinal large b-cell lymphoma."
Answered by AI
How many places are participating in this experiment?
"Patients are being sought from Froedtert and Medical College of Wisconsin ( Site 0022) in Milwaukee, Wisconsin, West virginia University - Charleston Area Medical Center ( Site 6003) in Charleston, West Virginia, Washington University ( Site 0003) in Saint Louis, Missouri as well 14 other hospitals."
Answered by AI
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