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: