Urinary Bladder NeoplasmsUrologic NeoplasmsReceptor, Fibroblast Growth Factor, Type 3
Investigational drug(s) / intervention(s)
Vepugratinib
Vepugratinib: Administered orally
Study summary
The main purpose of this study is to see how well vepugratinib works in adults with low grade, intermediate risk, non-muscle invasive bladder cancer (LG IR NMIBC) or low-grade upper tract urothelial carcinoma (LG UTUC). Safety tests will also be conducted.
For each participant, the study will last up to 5 years.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* All Participants:
* Have a PS of 0 to 2 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale
* Cohort A
* Have histologically confirmed LG NMIBC.
* Have LG IR NMIBC at time of screening
* Have a documented qualifying fibroblast growth factor receptor 3 protein (FGFR3) mutation or fusion
* Cohort B
* Have histologically confirmed LG UTUC.
Exclusion Criteria:
* All Participants
* Have had a prior positive urine cytology within 6 weeks of first day of treatment.
* Have received prior local instillation (for example, intravesical chemotherapy, Bacillus Calmette-Guerin, Jelmyto) therapy within 8 weeks of the first day of treatment.
* Cohort A
* Have synchronous UTUC disease.
* Have presence of, or history of, high-grade urothelial carcinoma within 3 years of the first day of treatment, or presence of, or history of, carcinoma in situ.
* Cohort B
* Have presence of bladder tumors at the time of enrollment.
* Have presence of, or history of, high-grade urothelial carcinoma or carcinoma in situ.
Primary outcome measure(s)
Number of Participants with LG IR NMIBC with Complete Response — Baseline, 2 Years Complete response rate is defined as negative cystoscopy and negative cytology .
Number of Participants with LG UTUC with Complete Response — Baseline, 2 Years Complete response rate is defined as negative uterorenoscopy or nephroscopy assessment and negative cytology, per investigator assessment.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.