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Chemotherapy
Pembrolizumab + Chemotherapy Before Surgery for Bladder Cancer
Phase 2
Waitlist Available
Led By Petros Grivas
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histology must be either pure or predominant non-urothelial histology (noted on any TURBT)
Patients must agree to undergo curative intent surgery
Must not have
Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing > 10 mg daily of prednisone dose equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
Has history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a mix of a drug that helps the immune system and another that targets cancer cells before surgery for a specific type of bladder cancer. It focuses on patients who may not respond well to usual treatments. The treatment helps the body fight cancer and uses drugs to kill or stop cancer cells.
Who is the study for?
This trial is for adults with muscle-invasive bladder cancer that looks unusual under the microscope and hasn't spread elsewhere. They must be fit for chemotherapy, surgery to remove the bladder, and willing to provide tissue samples. Participants need functioning major organs, no severe allergies to pembrolizumab or its components, no active hepatitis B/C or HIV, not pregnant or breastfeeding, and agree to use contraception.
What is being tested?
The study tests if combining pembrolizumab (an immune system-boosting drug) with chemotherapy drugs (methotrexate, vinblastine sulfate, doxorubicin hydrochloride, cisplatin) before surgery can better treat patients compared to chemotherapy alone. The goal is to see if this combination helps shrink the cancer more effectively before removing the bladder.
What are the potential side effects?
Possible side effects include reactions related to boosting the immune system which might affect different body parts like lungs or intestines; typical chemo-related issues such as nausea, hair loss; fatigue; increased risk of infections due to low blood cell counts; potential damage to kidneys from cisplatin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bladder cancer is mainly not urothelial type.
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I agree to have surgery aimed at curing my condition.
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My kidney function tests are within the required range.
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I am considered fit for specific bladder cancer treatments by my doctors.
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I haven't had a blood transfusion or taken erythropoietin in the last 2 weeks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I have had or currently have lung inflammation treated with steroids.
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I have been treated with specific immune therapy drugs before.
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I have not received a live vaccine in the last 30 days.
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I have an active hepatitis B or C infection.
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I have a known history of HIV.
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I have received an organ transplant from another person.
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My cancer does not have pure small cell characteristics.
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I am currently being treated for an infection.
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I have a known history of active tuberculosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Incidence of adverse events
Recurrence-free survival
Tumor infiltrating lymphocyte (TIL) density
Side 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%
Clostridium difficile colitis
1%
Systemic infection
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
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab
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: Treatment (pembrolizumab, aMVAC)Experimental Treatment7 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 of weeks 0, 3, and 6 and methotrexate IV, vinblastine IV, doxorubicin IV, and cisplatin IV on day 1 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC on day 1 or 2 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care radical cystectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3120
Radical Cystectomy
2006
Completed Phase 2
~140
Doxorubicin
2012
Completed Phase 3
~8030
Methotrexate
2019
Completed Phase 4
~4400
Pegfilgrastim
2013
Completed Phase 3
~4440
Pembrolizumab
2017
Completed Phase 3
~2810
Vinblastine Sulfate
2007
Completed Phase 4
~300
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Bladder cancer treatments often include immunotherapy and combination chemotherapy. Immunotherapy, such as pembrolizumab, uses monoclonal antibodies to enhance the body's immune response against cancer cells by targeting proteins like PD-1, which helps the immune system recognize and attack tumor cells.
This is crucial for patients as it can lead to more effective and sustained cancer control. Combination chemotherapy, involving drugs like methotrexate, vinblastine, adriamycin, and cisplatin, works by killing or inhibiting the growth and spread of cancer cells through various mechanisms, such as interfering with DNA replication and cell division.
This approach is vital for reducing tumor size and preventing metastasis, thereby improving patient outcomes.
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,010 Previous Clinical Trials
5,185,210 Total Patients Enrolled
University of WashingtonLead Sponsor
1,815 Previous Clinical Trials
1,913,031 Total Patients Enrolled
Petros GrivasPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bladder cancer has not spread, as confirmed by CT or MRI scans.My bladder cancer is mainly not urothelial type.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.My blood clotting time is normal or managed if I'm on blood thinners.I have not had cancer treatment or experimental drugs in the last 4 weeks.I have had or currently have lung inflammation treated with steroids.I am fully active or restricted in physically strenuous activity but can do light work.I agree to use contraception and not donate sperm for 180 days after my last treatment dose.I have been treated with specific immune therapy drugs before.I had a bladder surgery showing cancer invasion and can provide tissue samples for research.I have no progressing cancers except for treated skin, prostate, upper urinary tract, or urethra cancers.I agree to have surgery aimed at curing my condition.I have not received a live vaccine in the last 30 days.I am not pregnant or breastfeeding and either cannot become pregnant or agree to use birth control.My kidney function tests are within the required range.My bladder cancer is confirmed and has spread only within my pelvis.Your bilirubin levels must be within a certain range, as measured within 10 days before starting the study treatment.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.My blood clotting time is normal or managed with medication.I have an active hepatitis B or C infection.Your kidney function should be calculated according to the hospital's rules.Your platelet count is at least 100,000 per microliter within the past 10 days before starting the study treatment.Your white blood cell count is at least 1500 per microliter.Your hemoglobin level is at least 9.0 g/dL or 5.6 mmol/L in the 10 days before starting the study treatment.You have a severe allergic reaction to pembrolizumab or any of its ingredients.I am considered fit for specific bladder cancer treatments by my doctors.My scans show advanced cancer that cannot be surgically removed.I haven't had a blood transfusion or taken erythropoietin in the last 2 weeks.I have a known history of HIV.I have received an organ transplant from another person.Your AST and ALT levels in your blood are not more than 2.5 times the normal limit.I have recovered from side effects of previous treatments to my normal or mild condition.I am considered fit for intense chemotherapy or bladder tumor surgery.My cancer does not have pure small cell characteristics.I am currently being treated for an infection.I had radiotherapy over 2 weeks ago and have no side effects needing steroids.I have a known history of active tuberculosis.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, aMVAC)
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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