Renal Pelvis and Ureter Urothelial Carcinoma Clinical Trial
Official title:
Tolerability and Activity of Neoadjuvant Infigratinib, an Inhibitor of FGFR, in Upper Tract Urothelial Carcinoma
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.
PRIMARY OBJECTIVE: I. Evaluate the tolerability of infigratinib in patients with low-grade and high-grade platinum ineligible upper tract urothelial carcinoma (UTUC). SECONDARY OBJECTIVES: 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 hyperphosphatemia. 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. EXPLORATORY OBJECTIVES: 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. OUTLINE: 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 undergo surgery. After completion of study treatment, patients are followed up at 30 days, then every 3 months for up to 1 year after surgery. ;
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