Clinical trial · Interventional
A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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 or placebo will be administered in combination with enfortumab vedotin and pembrolizumab. Study participation could last up to approximately 6 years.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Transitional Cell | Transitional Cell Carcinoma | ALIAS | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EV | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Placebo | Other | — | UNRESOLVED |
| Vepugratinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Vepugratinib + EV + Pembrolizumab (Safety Lead In)
- description
- Vepugratinib administered orally with EV + pembrolizumab administered IV
- interventionNames
- Drug: Vepugratinib
- Drug: EV
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Vepugratinib + Enfortumab Vedotin (EV) + Pembrolizumab
- description
- Vepugratinib administered orally, and EV + pembrolizumab administered by intravenous (IV) infusion.
- interventionNames
- Drug: Vepugratinib
- Drug: EV
- Drug: Pembrolizumab
- type
- PLACEBO_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available