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Chemotherapy
Pembrolizumab + Chemotherapy Before Surgery for Bladder Cancer
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years
Awards & highlights
Study Summary
This trial is testing a new way to treat bladder cancer that has spread to the muscles. It's comparing a common cancer drug, methotrexate, to a new immunotherapy drug, pembrolizumab. The trial is for people with a certain type of muscle-invasive bladder cancer.
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.Check my eligibility
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.See study design
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.
Select...
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.
Select...
I haven't had a blood transfusion or taken erythropoietin in the last 2 weeks.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic complete response rate
Secondary outcome measures
Incidence of adverse events
Recurrence-free survival
Tumor infiltrating lymphocyte (TIL) density
Side 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
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
~1940
Radical Cystectomy
2006
Completed Phase 2
~140
Pegfilgrastim
2013
Completed Phase 3
~4410
Methotrexate
2013
Completed Phase 4
~3800
Vinblastine Sulfate
2007
Completed Phase 4
~300
Doxorubicin
2012
Completed Phase 3
~7940
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,059,918 Total Patients Enrolled
University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,847,653 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what conditions is Pembrolizumab commonly prescribed?
"Pembrolizumab has been clinically proven to be effective in treating advanced testicular cancer, as well as unresectable melanoma, microsatellite instability high and neuroblastoma (nb)."
Answered by AI
Has Pembrolizumab been previously evaluated in scientific research?
"Presently, there are 2227 Pembrolizumab clinical trials in progress. Of these studies, 535 are at the Phase 3 level. Many of them take place in Shanghai China; however numerous other sites around the globe (97843 to be precise) have enrolled patients as well."
Answered by AI
Does this clinical trial represent a pioneering approach?
"Since 1997, Alfacell has sponsored multiple trials of pembrolizumab. After the initial 300 patient study conducted in that year, Phase 3 approval was granted to this medical intervention. Presently, there are more than 2200 active studies spanning 85 nations and 4200 cities worldwide."
Answered by AI
For what number of participants is this study recruiting?
"Affirmative. Clinicaltrials.gov records that this medical research was first posted on November 24th 2020, and is still actively recruiting volunteers for participation. As of now, 17 individuals are needed from a single site to complete the trial."
Answered by AI
To what extent can Pembrolizumab be harmful to human health?
"Due to the fact that Pembrolizumab is currently undergoing Phase 2 trials, there is limited evidence of safety but nothing yet supporting efficacy. Consequently, this medication was given a score of 2 on our internal rating system."
Answered by AI
Are there any available enrolment slots left for this experiment?
"According to clinicaltrials.gov, this study is still recruiting candidates for participation. It was initially posted on 24th November 2020 and has been revised as recently as 16th August 2022."
Answered by AI
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