Phase 3 Bladder Cancer Trial, RecruitingNCT07218380Sponsor: Eli Lilly and CompanyCondition: Bladder Cancer
Printed from Voxsanity (voxsanity.com.au) — NCT07218380 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
AI generated eligibility summary.
Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source.
How we use AI
Who might be able to join this trial:
You have been diagnosed with bladder or urinary tract cancer (urothelial cancer) that cannot be removed by surgery and has either spread to nearby tissues or to other parts of the body, confirmed by a tissue biopsy. Mixed cancer types may be eligible as long as urothelial cancer cells are present (but not if small cell or neuroendocrine cancer cells are present).
A genetic test on your tumor or blood sample (taken at any point after your advanced cancer diagnosis) has found a specific change in a gene called FGFR3.
Your cancer can be measured on scans according to standard medical guidelines (confirm with trial site).
You are reasonably well and able to carry out everyday activities, rated on a standard scale from 0 (fully active) to 2 (up and about more than half the day but unable to do physical work).
Your recent blood test results meet certain health thresholds set by the trial (confirm with trial site for specific values).
Who may not be able to join:
You have already received systemic treatment (such as chemotherapy or immunotherapy given throughout the body) for your advanced or metastatic urothelial cancer.
You still have side effects higher than a mild level from any previous chemotherapy or immunotherapy given before or after surgery.
You currently have nerve damage (numbness, tingling, or weakness) in your hands, feet, or elsewhere that is moderate or worse.
You have cancer that has spread to your brain or spinal fluid, or it has not been fully treated or is not under control.
An eye examination at the start of the trial shows current signs of a cornea or retina problem in your eyes.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Western Health-Sunshine & Footscray Hospitals, St Albans,
412139261
Calvary Mater Newcastle, Waratah,
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I am writing to enquire about the following clinical trial which may be relevant to my care:
Trial: NCT07218380
Sponsor: Eli Lilly and Company
Phase: Phase 3
Status: Recruiting
Condition: Bladder Cancer
Trial contact: 1-317-615-4559
More information: https://clinicaltrials.gov/study/NCT07218380
Eligibility summary (AI generated)
Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
You have been diagnosed with bladder or urinary tract cancer (urothelial cancer) that cannot be removed by surgery and has either spread to nearby tissues or to other parts of the body, confirmed by a tissue biopsy. Mixed cancer types may be eligible as long as urothelial cancer cells are present (but not if small cell or neuroendocrine cancer cells are present).
A genetic test on your tumor or blood sample (taken at any point after your advanced cancer diagnosis) has found a specific change in a gene called FGFR3.
Your cancer can be measured on scans according to standard medical guidelines (confirm with trial site).
You are reasonably well and able to carry out everyday activities, rated on a standard scale from 0 (fully active) to 2 (up and about more than half the day but unable to do physical work).
Your recent blood test results meet certain health thresholds set by the trial (confirm with trial site for specific values).
Who may not be able to join:
You have already received systemic treatment (such as chemotherapy or immunotherapy given throughout the body) for your advanced or metastatic urothelial cancer.
You still have side effects higher than a mild level from any previous chemotherapy or immunotherapy given before or after surgery.
You currently have nerve damage (numbness, tingling, or weakness) in your hands, feet, or elsewhere that is moderate or worse.
You have cancer that has spread to your brain or spinal fluid, or it has not been fully treated or is not under control.
An eye examination at the start of the trial shows current signs of a cornea or retina problem in your eyes.
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 27 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
🇦🇺 Australia
🇧🇷 Brazil
🇨🇦 Canada
🇨🇳 China
🇨🇿 Czechia
🇩🇰 Denmark
🇫🇷 France
🇩🇪 Germany
🇭🇺 Hungary
🇮🇹 Italy
🇯🇵 Japan
🇳🇱 Netherlands
🇵🇱 Poland
🇰🇷 South Korea
🇪🇸 Spain
🇹🇼 Taiwan
Turkey (Türkiye)
🇬🇧 United Kingdom
🇺🇸 United States
9 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of participants with treatment-related adverse events related to vepugratinib in combination with EV and pembrolizumab; Safety Lead-in: Overall Response Rate (ORR); Progression-free Survival (PFS)
Can't join this trial?
Expanded access pathways
If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.