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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
450
Number of participants with treatment-related adverse events related to vepugratinib in combination with EV and pembrolizumab
Time frame: From baseline up to 90 months
Safety Lead-in: Overall Response Rate (ORR)
ORR by Investigator Assessment.
Time frame: From baseline up to 90 months
Progression-free Survival (PFS)
PFS by blinded independent committee review (BICR).
Time frame: Baseline to Study Completion (estimated as 6 years)
Safety Lead-in: Disease Control Rate (DCR)
DCR by investigator assessment.
Time frame: From baseline up to the end of Cycle 2 (each Cycle is 21 days)
Safety Lead-in: Time to Response (TTR)
TTR by investigator assessment.
Time frame: From baseline up to 90 months
Overall Survival (OS)
Time frame: Baseline to Study Completion (estimated as 6 years)
Objective Response Rate (ORR) by BICR
Time frame: Baseline to Study Completion (estimated as 6 years)
Duration of Response (DoR)
DOR by BICR.
Time frame: Baseline to Study Completion (estimated as 6 years)
Progression-free Survival (PFS)
PFS by investigator assessment.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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Administered by IV infusion
Clearview Cancer Institute
Huntsville, Alabama, United States
RECRUITINGThe University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
NOT_YET_RECRUITINGTRIO-US (Translational Research in Oncology-US)
Los Angeles, California, United States
NOT_YET_RECRUITINGUCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States
NOT_YET_RECRUITINGUniversity of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, United States
NOT_YET_RECRUITINGUCSF Medical Center at Mission Bay
San Francisco, California, United States
NOT_YET_RECRUITINGHunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer (TMPN)
Torrance, California, United States
NOT_YET_RECRUITINGAdventHealth Medical Group - Porter
Denver, Colorado, United States
NOT_YET_RECRUITINGColorado West Healthcare System - Grand Valley Oncology
Grand Junction, Colorado, United States
NOT_YET_RECRUITINGAdventHealth Orlando
Orlando, Florida, United States
NOT_YET_RECRUITING...and 266 more locations
Time frame: Baseline to Study Completion (estimated as 6 years)
Objective Response Rate (ORR)
Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)ORR by investigator assessment
Time frame: Baseline to Study Completion (estimated as 6 years)
Duration of Response (DOR)
DOR by investigator assessment.
Time frame: Baseline to Study Completion (estimated as 6 years)
Progression-free Survival 2 (PFS2)
PFS2 by investigator assessment.
Time frame: Baseline to Study Completion (estimated as 6 years)
Plasma Concentrations of Vepugratinib
PK samples are to be drawn every odd cycle while participant on study.
Time frame: Cycle 1 Day 1 to Study completion (estimated as 90 months)
Change from Baseline in Global Health Status/Quality of Life (QOL) and Physical Function Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 is a validated self-reported general cancer questionnaire consisting of 30 items with a recall of the past 7 days. Response options range from 1) "very poor" to 7) "excellent." Higher scores represent better overall HRQoL.
Time frame: Baseline to Study Completion (estimated as 6 years)