Tazemetostat + Pembrolizumab for Bladder Cancer
Recruiting in Palo Alto (17 mi)
+37 other locations
Overseen ByMaha H Hussain
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: National Cancer Institute (NCI)
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This phase I/II trial studies the side effects and best dose of tazemetostat and how well it works when given together with pembrolizumab in treating patients with urothelial carcinoma that has spread to nearby tissue or lymph nodes (locally advanced ) or from where it first started (primary site) to other places in the body (metastatic). Tazemetostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tazemetostat and pembrolizumab may work better in treating patients with urothelial carcinoma compared to pembrolizumab without tazemetostat.
Eligibility Criteria
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.Inclusion Criteria
I have never been treated with PD-L1 or EZH2 inhibitors.
I am 18 years old or older.
My kidney function, measured by creatinine levels or clearance, is within the normal range.
My cancer is confirmed as urothelial carcinoma.
My cancer has spread beyond its original location.
I can take care of myself and am up and about more than half of my waking hours.
Exclusion Criteria
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 brain metastases or carcinomatous meningitis.
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 or had a blood cancer or disorder affecting blood cell production.
My tests show genetic changes linked to certain blood disorders.
I cannot take pills or have a condition that affects how my body absorbs food.
Participant Groups
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.
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.
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
🇺🇸 Approved in United States as KEYTRUDA for:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
🇪🇺 Approved in European Union as KEYTRUDA for:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
🇬🇧 Approved in United Kingdom as KEYTRUDA for:
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Pittsburgh Cancer Institute (UPCI)Pittsburgh, PA
Mayo Clinic in ArizonaScottsdale, AZ
The University of Kansas Cancer Center - OlatheOlathe, KS
Smilow Cancer Hospital Care Center - GuifordGuilford, CT
More Trial Locations
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Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor