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Checkpoint Inhibitor
Tazemetostat + Pembrolizumab for Bladder Cancer
Phase 1 & 2
Waitlist Available
Led By Maha H Hussain
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be naive to prior PD-L1 or EZH2 inhibitors
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing tazemetostat + pembrolizumab to treat patients with urothelial carcinoma that has spread. Tazemetostat may stop growth of tumor cells by blocking enzymes needed for cell growth. Pembrolizumab is an immunotherapy that may help the body's immune system attack the cancer.
Who is the study for?
Adults (18+) with advanced urothelial carcinoma that hasn't spread to the brain, without prior treatment with PD-L1 or EZH2 inhibitors. They must have measurable disease, be in fairly good health (ECOG <=2), and have normal organ function tests. HIV-positive patients can join if they're on effective therapy with an undetectable viral load. Participants need to understand and sign consent forms and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing how well tazemetostat works alongside pembrolizumab compared to just pembrolizumab for treating advanced urothelial carcinoma. Tazemetostat blocks enzymes that help cancer cells grow, while pembrolizumab boosts the immune system's ability to fight cancer.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation of organs, fatigue, digestive issues like nausea or diarrhea, skin rash, liver enzyme changes, potential blood disorders like anemia or clotting problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never been treated with PD-L1 or EZH2 inhibitors.
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I am 18 years old or older.
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My kidney function, measured by creatinine levels or clearance, is within the normal range.
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My cancer is confirmed as urothelial carcinoma.
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My cancer has spread beyond its original location.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase 2 dose (RP2D) of tazemetostat in combination with pembrolizumab
Secondary outcome measures
Incidence of adverse events
Objective response rate (ORR)
Progression free survival
+1 moreOther outcome measures
EZH2 and H3K27me3 chromatin methylation and mutations in genes associated with histone methylation
Immune response
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tazemetostat, pembrolizumab)Experimental Treatment5 Interventions
Patients receive tazemetostat PO BID on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the trial and undergo collection of blood samples on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Tazemetostat
2016
Completed Phase 2
~1050
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,687 Previous Clinical Trials
40,930,341 Total Patients Enrolled
Maha H HussainPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
1 Previous Clinical Trials
159 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's electrical activity takes too long, as measured by the QT interval, which can be risky for the study.I am HIV-positive, on effective treatment, and have no history of Kaposi sarcoma or Multicentric Castleman Disease.My tests show genetic changes linked to certain blood disorders.Your absolute neutrophil count is at least 1500 per microliter.I have not taken steroids or immunosuppressants in the last 7 days.I have had pneumonitis treated with steroids or have it now.I haven't had chemotherapy, targeted therapy, or radiotherapy in the last 4 weeks.I have severe low blood platelet, white cell, or red cell counts.I have never been treated with PD-L1 or EZH2 inhibitors.I have brain metastases or carcinomatous meningitis.I am 18 years old or older.I haven't taken strong or moderate drugs affecting liver enzymes in the last 14 days.I have previously been treated with PD-L1, PD-1, PD-L2, or EZH2 inhibitors.I have an autoimmune disease treated within the last 2 years.I have a history of hepatitis B or C.I have not received a live vaccine in the last 30 days.Your white blood cell count is at least 3000 per microliter.Your bilirubin levels must be within a certain range.My kidney function, measured by creatinine levels or clearance, is within the normal range.Your blood clotting time is within a normal range.I have or had a blood cancer or disorder affecting blood cell production.I have not had major surgery in the last 3 weeks.Your blood clotting time should not be more than 1.5 times the normal level.I haven't had blood products or colony stimulating factors in the last 4 weeks.I still have side effects from previous cancer treatments.My condition can be treated with the goal of curing it.I haven't taken any monoclonal antibody treatments in the last 4 weeks.Your liver enzymes (AST and ALT) should not be higher than a certain level, unless you have liver metastases, in which case they can be a bit higher.I have been cancer-free for over 5 years, except for certain skin cancers or cervical pre-cancer.You have had allergic reactions to drugs similar to pembrolizumab or tazemetostat.My cancer is confirmed as urothelial carcinoma.My cancer has spread beyond its original location.I cannot take pills or have a condition that affects how my body absorbs food.Patients must have a measurable disease that can be seen and tracked according to specific guidelines.I can take care of myself and am up and about more than half of my waking hours.Your platelet count is at least 100,000 per microliter.Your hemoglobin level is at least 9 g/dL or 4.9 mmol/L.I can understand and am willing to sign the consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tazemetostat, pembrolizumab)
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.
How many institutes are administering this trial?
"This trial is being carried out at 31 sites, including Truman Medical Centers in Kansas City, Smilow Cancer Hospital Care Center-Trumbull in Trumbull and University of Kansas Hospital-Westwood Cancer Center in Westwood. A few other centres are also involved."
Answered by AI
Are there any other experiments that have utilized Tazemetostat?
"Presently, 979 trials focused on Tazemetostat are in progress with 124 of them being Phase 3. Of these studies, the majority occur in Houston Texas; however, there are 36998 different sites all over America actively running tests for this drug."
Answered by AI
What have been the primary applications of Tazemetostat treatment?
"Tazemetostat is mainly used to treat malignant neoplasms, but it has also been administered to patients suffering from unresectable melanoma, microsatellite instability high or disease progression after chemotherapy."
Answered by AI
How many subjects are being monitored for this research project?
"Affirmative. Clinicaltrials.gov lists this medical trial as currently searching for patients, which has been posted since May 17th 2019 and most recently revised on November 8th 2022. 30 test subjects are needed between 31 different clinical sites."
Answered by AI
Is it currently feasible for individuals to enroll in this experiment?
"According to information on clinicaltrials.gov, this trial is in its recruitment phase and was first posted on May 17th 2019 with its most recent update occurring November 8th 2022."
Answered by AI
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