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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with treatment-related adverse events related to vepugratinib in combination with EV and pembrolizumab

Primary Outcome 1 - Timeframe: From baseline up to 90 months

Primary Outcome 2 - Measure: Safety Lead-in: Overall Response Rate (ORR)

Primary Outcome 2 - Timeframe: From baseline up to 90 months

Primary Outcome 3 - Measure: Progression-free Survival (PFS)

Primary Outcome 3 - Timeframe: Baseline to Study Completion (estimated as 6 years)

CONDITION

• Carcinoma
• Transitional Cell
• Urinary Bladder Neoplasms
• Neoplasm Metastasis

ELIGIBILITY

Inclusion 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
Exclusion 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: 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)

Role: Study Director

Affiliation: Eli Lilly and Company

Overall Contact

Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or, Physicians interested in becoming principal investigators please contact

Phone: 1-317-615-4559

Email: [email protected], [email protected]

LOCATION