NIPH Clinical Trials Search

A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Carcinoma, Transitional Cell Urinary Bladder Neoplasms Neoplasm Metastasis
Date of first enrollment	01/12/2025
Target sample size	450
Countries of recruitment	United States,Japan,Australia,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Hungary,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Turkey (Turkiye),Japan,United Kingdom,Japan
Study type	Interventional
Intervention(s)	DRUG: Vepugratinib Administered orally OTHER: Placebo Administered orally DRUG: EV Administered by IV infusion DRUG: Pembrolizumab Administered by IV infusion (Study Arms) Experimental: Vepugratinib + EV + Pembrolizumab (Safety Lead In) Vepugratinib administered orally with EV + pembrolizumab administered IV Interventions: Drug: Vepugratinib Drug: EV Drug: Pembrolizumab Experimental: Vepugratinib + Enfortumab Vedotin (EV) + Pembrolizumab Vepugratinib administered orally, and EV + pembrolizumab administered by intravenous (IV) infusion. Interventions: Drug: Vepugratinib Drug: EV Drug: Pembrolizumab Placebo Comparator: Placebo + EV + Pembrolizumab Placebo administered orally, and EV + pembrolizumab administered by IV infusion. Interventions: Other: Placebo Drug: EV Drug: Pembrolizumab

Outcome(s)

Primary Outcome	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
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	- Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present. - Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample obtained at or any time after diagnosis of advanced or metastatic urothelial cancer. - Have measurable disease by investigator assessment defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. - Have adequate laboratory parameters
Exclude criteria	- Have received prior systemic therapy for locally advanced or metastatic urothelial cancer (mUC). - Have any unresolved toxicities greater than Grade 1 Common Terminology Criteria for Adverse Events ([CTCAE] version 5.0) from prior neoadjuvant or adjuvant systemic therapy. - Have ongoing sensory or motor neuropathy of Grade 2 or higher - Have untreated or uncontrolled central nervous system (CNS) involvement or any history of leptomeningeal disease. - Current evidence corneal keratopathy or retinal disorder confirmed by ocular examination at screening.