This phase Ib trial studies the side effects of infigratinib before surgery in treating
patients with upper tract urothelial cancer. Infigratinib may stop the growth of tumor cells
by blocking the activities of a gene called FGFR needed for cell growth. Giving infigratinib
before surgery may cause the tumor to shrink, which may make the surgical procedure easier
and/or reduce the need for more extensive surgery.
I. Evaluate the tolerability of infigratinib in patients with low-grade and high-grade
platinum ineligible upper tract urothelial carcinoma (UTUC).
I. Assess tolerability in those with GFR 30-49. II. Evaluate the objective response rate
(complete response [CR] + partial response [PR]) of infigratinib after 2 cycles in UTUC with
and without FGFR3 alterations.
III. Correlate tumor tissue FGFR3 alteration (presence/absence, alteration type, and clonal
status) with response and occurrence/severity of adverse events (AEs) such as
IV. Evaluate upper tract, bladder and local/distant recurrence within 12 months.
V. Evaluate renal function pre-treatment and after two treatments. VI. Evaluate
patient-reported quality of life (QOL) outcomes during treatment.
I. Explore intra-tumor heterogeneity, gene expression profiles, and changes in tumor
microenvironment using single cell ribonucleic acid (RNA) sequencing (scRNA-seq) and mass
cytometry by time-of-flight (CyTOF) pre and post treatment to identify potential mechanisms
of response and/or resistance, and correlation with the occurrence/severity of AEs.
II. Explore urinary/upper tract washing FGFR3 alterations as potential biomarker for
detection and response.
III. Explore cell free deoxyribonucleic acid (cfDNA) for detection of FGFR3 alterations and
as a predictor of response.
Patients receive infigratinib orally (PO) once daily (QD) on days 1-21. Treatment repeats
every 28 days for up to 2 cycles in the absence of disease progression or unacceptable
toxicity. During weeks 8-9 (at least 48 hours after last dose of infigratinib), patients
After completion of study treatment, patients are followed up at 30 days, then every 3 months
for up to 1 year after surgery.
Renal Pelvis and Ureter Urothelial Carcinoma,
urothelial carcinoma of the upper urinary tract
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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