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Trial Information
Molecule Overview
FGFR3 Inhibitor
Vepugratinib
Phase
3
Active, not recruiting
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
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Molecule Overview Trial Enrollment
FORAGER-2 Trial
Key Inclusion Criteria
  • Participants are included in the study only if all the following criteria apply:
    • Have untreated locally advanced or metastatic urothelial carcinoma. Individuals with mixed histology are eligible if a urothelial component is present, excluding small cell or neuroendocrine carcinoma
    • Have a susceptible FGFR3 genetic alteration on local or trial-enabled testing on blood or tissue
    • Have measurable disease by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
    • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
    • Have adequate bone marrow, hepatic, and renal function laboratory parameters as defined by the protocol
Key Exclusion Criteria
  • Had received prior systemic therapy for locally advanced or metastatic urothelial carcinoma (UC) except:
    • Neoadjuvant or adjuvant systemic therapy for localized urothelial cancer with recurrence more than 12 months after completion of therapy
    • One cycle of standard-of-care enfortumab vedotin (EV) + pembrolizumab for locally advanced or metastatic urothelial carcinoma (mUC) before study enrollment for cases where immediate treatment is clinically indicated
  • Any unresolved serious toxicities from prior therapy, except alopecia, hearing loss, and stable endocrinopathies
  • Have ongoing sensory or motor neuropathy of Grade 2 or higher
  • Current evidence of corneal keratopathy or retinal disorder, except individuals with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk to study participation
  • Have untreated or uncontrolled central nervous system (CNS) involvement or a history of leptomeningeal disease. Patients with treated brain metastases who are clinically stable prior to screening are permitted on the study
a
Safety lead-in will be opened first as per sponsor’s discretion and once completed the randomized portion will open. Participants in the safety lead-in will have an ECOG performance of 0-1 and are allowed up to 2 cycles of EV + pembrolizumab before C1D1.
b
Stratified by ECOG 0-2; geographical region (North America or Europe vs Asia vs other); liver or bone metastases (yes vs no).
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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