A Phase 3 interventional study of Vepugratinib and Placebo in Carcinoma, Transitional Cell, Urinary Bladder Neoplasms and Neoplasm Metastasis, sponsored by Eli Lilly and Company. Recruiting at 276 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
633 studies on the registry are indexed under Carcinoma, Transitional Cell; 181 are open to participants now.
This study's planned enrollment of 450 is above the median of 50 across 500 interventional studies indexed under Carcinoma, Transitional Cell.
Browse Carcinoma, Transitional Cell studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vepugratinib administered orally with EV + pembrolizumab administered IV
Drug: Vepugratinib · Drug: EV · Drug: Pembrolizumab
Vepugratinib administered orally, and EV + pembrolizumab administered by intravenous (IV) infusion.
Drug: Vepugratinib · Drug: EV · Drug: Pembrolizumab
Placebo administered orally, and EV + pembrolizumab administered by IV infusion.
Other: Placebo · Drug: EV · Drug: Pembrolizumab
Administered orally
Administered orally
Administered by IV infusion
Administered by IV infusion
This study also gives Enfortumab vedotin. No intervention listed here names it: that was found by reading the record.
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.
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)
Not enrolling at this site — choose another above.
Showing the first 100 of 276 sites across 19 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Data sharing details ↗ · vivli.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Vepugratinib
Carcinoma, Transitional Cell →