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Clinical Trials List

Protocol NumberJ4G-MC-JZVD
NCT Number(ClinicalTrials.gov Identfier)NCT07218380
Not yet recruiting

2025-12-01 - 2033-05-05

Phase III

Recruiting5

ICD-10C67.9

Malignant neoplasm of bladder, unspecified

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9188.9

Malignant neoplasm of bladder, part unspecified

FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/08

Investigators and Locations

Principal Investigator 康乃文 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

Principal Investigator Wen-Jeng Wu Division of Urology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

Principal Investigator 陳彥勳 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

Principal Investigator Yu-Chieh Tsai Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

Principal Investigator Ying-Chun Shen Division of Hematology & Oncology
National Taiwan University Cancer Center

Co-Principal Investigator

Principal Investigator Jian-Ri Li Division of Urology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Li Su Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiu Huang Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hsiang Chang Division of Urology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Pin Su
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Carcinoma, Transitional Cell、 Urinary Bladder Neoplasms 、Neoplasm Metastasis

Objectives

This trial aims to evaluate the efficacy and safety of vepugratinib plus existing standard of care (EV) + pembrolizumab in adult patients with FGFR3 gene mutations who have not received prior treatment for locally advanced or metastatic urothelial carcinoma, compared to EV + pembrolizumab alone.

Test Drug

N/A

Active Ingredient

LY3866288

Dosage Form

N/A

Dosage

100mg

Endpoints

Deterioration-free survival as assessed by the Blinded Independent Committee Review (BICR)

Inclution Criteria

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

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.

The Estimated Number of Participants

  • Taiwan

    60 participants

  • Global

    450 participants

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