This study is not yet accepting patients

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

a study on Transitional Cell Carcinoma Bladder Cancer Urinary Bladder Tumor Neoplasm Metastasis FGFR Gene Alteration

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
study ends around
Principal Investigator
by Alexandra Drakaki (ucla)Vadim Koshkin (ucsf)
Headshot of Vadim Koshkin
Vadim Koshkin

Description

Summary

The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread.

Vepugratinib and placebo will be administered in combination with existing standard of care (SOC) therapy.

Study participation could last up to approximately 6 years.

Official Title

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

Keywords

Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Neoplasm Metastasis, FGFR3, Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Transitional Cell Carcinoma, pembrolizumab, Vepugratinib, Vepugratinib + EV + Pembrolizumab (Safety Lead In), Vepugratinib + Enfortumab Vedotin (EV) + Pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • UCLA Hematology/Oncology - Santa Monica
    Los Angeles 5368361 California 5332921 90404 United States
  • UCSF Medical Center at Mission Bay
    San Francisco 5391959 California 5332921 94158 United States
  • TRIO-US (Translational Research in Oncology-US)
    Los Angeles 5368361 California 5332921 90024 United States
  • Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer (TMPN)
    Torrance 5403022 California 5332921 90505 United States

Lead Scientists at University of California Health

  • Alexandra Drakaki (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 126 research publications
  • Vadim Koshkin (ucsf)
    I am a genitourinary medical oncologist and in this capacity I specialize in caring for patients with bladder, prostate, kidney and testicular cancers.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT07218380
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 450 study participants
Last Updated