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Checkpoint Inhibitor
Pembrolizumab for Bladder Cancer
Phase 2
Recruiting
Led By Matthew D Galsky, MD
Research Sponsored by Vaibhav Patel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer treatment. Subjects have urothelial cancer of the bladder and will be given two cycles of pembrolizumab. If they respond well to the treatment, they will continue to receive it, otherwise they will receive standard care.
Who is the study for?
Adults with muscle-invasive urothelial bladder cancer (cT2-T3N0M0) who haven't had systemic chemotherapy or radiation for it, can decline or are ineligible for cisplatin-based chemo due to certain health conditions. They must have adequate organ function and agree to use contraception. Excluded if pregnant, breastfeeding, recently vaccinated with live vaccines, have active infections or other health issues that could affect the trial.
What is being tested?
The trial is testing Pembrolizumab in patients after they've undergone tumor removal surgery. Patients will receive two cycles of Pembrolizumab followed by MRI/CT scans and cystoscopy to check response. Those responding well continue on Pembrolizumab; others follow standard care then get 'adjuvant' Pembrolizumab.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs, infusion reactions similar to allergic responses, fatigue, liver enzyme changes suggesting liver irritation, and an increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Benefit from Treatment
Clinical Complete Response Rate (CRR)
Secondary study objectives
Assess adverse events
Bladder-Intact Overall Survival
Bladder-intact Event Free Survival
+6 moreSide effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental GroupExperimental Treatment1 Intervention
Cycles 1-2 (Pembrolizumab): 400 mg of Pembrolizumab intravenously (Administered Day 1 of 42 day Cycle)
If complete response of treatment is observed then maintenance therapy will be given. All other patients will receive with standard of care local therapy (cystectomy or chemo-radiation) as per their treating physicians followed by "adjuvant" pembrolizumab.
Cycle 3-9 (Maintenance or Adjuvant Single agent Pembrolizumab): 400 mg of Pembrolizumab intravenously (Administered Day 1 of 42 day Cycle)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,015 Previous Clinical Trials
5,186,287 Total Patients Enrolled
Vaibhav PatelLead Sponsor
Matthew GalskyLead Sponsor
10 Previous Clinical Trials
375 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received radiation therapy for bladder cancer before.You had a cancer that was treated and cured, or you have low-risk prostate cancer according to specific guidelines.You have an infection that needs medication to treat.You have a history of Hepatitis B or C, but if it is resolved or in the past, you may still be eligible. If you are positive for Hepatitis C, you can still participate if a specific test is negative. Testing for Hepatitis B and Hepatitis C is only needed if local health authorities require it.You have been diagnosed with HIV. Testing for HIV is not needed unless the local health authority requires it.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.You have a history of lung inflammation that needed steroids, or you currently have lung inflammation.You have bladder cancer that has not spread to other parts of the body and specific criteria regarding the size of lymph nodes on imaging.You have had a complete surgical removal of your bladder tumor within the last 60 days, and it was done as thoroughly as possible according to your doctor. If you couldn't have the complete removal for safety reasons, you can still join the study but this needs to be discussed with the study leader.Your blood counts, kidney function, and liver function must be within a certain range. Women who can have children need to have a negative pregnancy test and agree to use birth control. Men need to agree to use contraception.You have not received chemotherapy for muscle-invasive bladder cancer before.You have had a tissue or organ transplant from someone else.You have already been treated with a certain type of medication that affects the immune system.You have a weakened immune system, or you are taking strong medication that weakens your immune system.You have an autoimmune disease that needed strong medication in the past 2 years. Hormone replacement therapy is okay.You cannot have certain types of kidney function, hearing loss, neuropathy, or heart failure that would make you ineligible for a specific type of chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Group
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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