Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03854474
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Locally Advanced Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma
  • Stage III Bladder Cancer AJCC v8
  • Stage IV Bladder Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Tazemetostat — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Nov 18, 2019
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (tazemetostat, pembrolizumab)
    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.

Primary Outcome Measure

Recommended phase 2 dose (RP2D) of tazemetostat in combination with pembrolizumab [ Time Frame: Up to 21 days following the first dose of tazemetostat ]

Locations (33)

FacilityCityStateZIPSite coordinators
Mayo Clinic Hospital in ArizonaPhoenixArizona85054-
Mayo Clinic in ArizonaScottsdaleArizona85259-
Smilow Cancer Hospital-Derby Care CenterDerbyConnecticut06418-
Smilow Cancer Hospital Care Center-FairfieldFairfieldConnecticut06824-
Smilow Cancer Hospital Care Center - GuilfordGuilfordConnecticut06437-
Smilow Cancer Hospital Care Center at Saint FrancisHartfordConnecticut06105-
Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticut06510-
Yale UniversityNew HavenConnecticut06520-
Yale-New Haven Hospital North Haven Medical CenterNorth HavenConnecticut06473-
Smilow Cancer Hospital-Orange Care CenterOrangeConnecticut06477-
Smilow Cancer Hospital-Torrington Care CenterTorringtonConnecticut06790-
Smilow Cancer Hospital Care Center-TrumbullTrumbullConnecticut06611-
Smilow Cancer Hospital-Waterbury Care CenterWaterburyConnecticut06708-
Smilow Cancer Hospital Care Center - WaterfordWaterfordConnecticut06385-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Northwestern UniversityChicagoIllinois60611-
University of Kansas Clinical Research CenterFairwayKansas66205-
HaysMedHaysKansas67601-
Lawrence Memorial HospitalLawrenceKansas66044-
The University of Kansas Cancer Center - OlatheOlatheKansas66061-
University of Kansas Cancer Center-Overland ParkOverland ParkKansas66210-
Mercy Hospital PittsburgPittsburgKansas66762-
Salina Regional Health CenterSalinaKansas67401-
University of Kansas Health System Saint Francis CampusTopekaKansas66606-
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
Mayo Clinic in RochesterRochesterMinnesota55905-
University Health Truman Medical CenterKansas CityMissouri64108-
University of Kansas Cancer Center - NorthKansas CityMissouri64154-
University of Kansas Cancer Center - Lee's SummitLee's SummitMissouri64064-
University of Kansas Cancer Center at North Kansas City HospitalNorth Kansas CityMissouri64116-
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanonNew Hampshire03756-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

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Mayo Clinic Hospital in Arizona· Phoenix, AZMayo Clinic in Arizona· Scottsdale, AZSmilow Cancer Hospital-Derby Care Center· Derby, CTSmilow Cancer Hospital Care Center-Fairfield· Fairfield, CTSmilow Cancer Hospital Care Center - Guilford· Guilford, CTSmilow Cancer Hospital Care Center at Saint Francis· Hartford, CT

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