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Purpose

The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread. Vepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab. Study participation could last up to approximately 6 years.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present. - Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample obtained at or any time after diagnosis of advanced or metastatic urothelial cancer. - Have measurable disease by investigator assessment defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. - Have adequate laboratory parameters

Exclusion Criteria

  • Have received prior systemic therapy for locally advanced or metastatic urothelial cancer (mUC). - Have any unresolved toxicities greater than Grade 1 Common Terminology Criteria for Adverse Events ([CTCAE] version 5.0) from prior neoadjuvant or adjuvant systemic therapy. - Have ongoing sensory or motor neuropathy of Grade 2 or higher - Have untreated or uncontrolled central nervous system (CNS) involvement or any history of leptomeningeal disease. - Current evidence corneal keratopathy or retinal disorder confirmed by ocular examination at screening.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
There will be an open-label safety lead in.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Vepugratinib + EV + Pembrolizumab (Safety Lead In) 		Vepugratinib administered orally with EV + pembrolizumab administered IV
  • Drug: Vepugratinib
    Administered orally
  • Drug: EV
    Administered by IV infusion
  • Drug: Pembrolizumab
    Administered by IV infusion
Experimental
Vepugratinib + Enfortumab Vedotin (EV) + Pembrolizumab 		Vepugratinib administered orally, and EV + pembrolizumab administered by intravenous (IV) infusion.
  • Drug: Vepugratinib
    Administered orally
  • Drug: EV
    Administered by IV infusion
  • Drug: Pembrolizumab
    Administered by IV infusion
Placebo Comparator
Placebo + EV + Pembrolizumab 		Placebo administered orally, and EV + pembrolizumab administered by IV infusion.
  • Other: Placebo
    Administered orally
  • Drug: EV
    Administered by IV infusion
  • Drug: Pembrolizumab
    Administered by IV infusion

Recruiting Locations

Clearview Cancer Institute
Huntsville, Alabama 35805
Contact:
256-705-4224

UCLA Hematology/Oncology - Santa Monica
Los Angeles, California 90404

UCSF Medical Center at Mission Bay
San Francisco, California 94158
Contact:
773-837-0783

Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer (TMPN)
Torrance, California 90505
Contact:
310-750-3300

Colorado West Healthcare System - Grand Valley Oncology
Grand Junction, Colorado 81505
Contact:
970-644-4460

University of Illinois at Chicago
Chicago, Illinois 60612

Parkview Research Center at Parkview Regional Medical Center
Fort Wayne, Indiana 46845

Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202

Franciscan Health
Indianapolis, Indiana 46237

Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
Contact:
225-215-1185

Johns Hopkins Hospital
Baltimore, Maryland 21287

Karmanos Cancer Institute
Detroit, Michigan 48201

Oncology Hematology Associates
Springfield, Missouri 65807
Contact:
417-882-4880

Washington University School of Medicine
St Louis, Missouri 63108

Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
646-888-4737

Oncology Specialists of Charlotte
Charlotte, North Carolina 28207

Providence Portland Medical Center
Portland, Oregon 97213

Providence St. Vincent Medical Center
Portland, Oregon 97225

Kaiser Permanente Interstate Medical Office Central
Portland, Oregon 97227
Contact:
503-249-3315

Avera Cancer Institute- Research
Sioux Falls, South Dakota 57105

Sarah Cannon Research Institute
Nashville, Tennessee 37203

SCRI Oncology Partners
Nashville, Tennessee 37203

Tennessee Oncology
Nashville, Tennessee 37203

USO-Texas Oncology-Central/South Texas
Austin, Texas 78731

World Research Link
Baytown, Texas 77521
Contact:
833-832-8328

UT Southwestern Medical Center
Dallas, Texas 75390
Contact:
214-648-4180

University of Texas MD Anderson Cancer Center
Houston, Texas 77030-4009

Nova Oncology
McAllen, Texas 78504
Contact:
281-944-3610

US Oncology Research Network
The Woodlands, Texas 77380

USO - Texas Oncology - Northeast Texas
Tyler, Texas 75702

USO - Virginia Oncology Associates
Norfolk, Virginia 23502

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.