Recruiting NCT07218380

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

Phase III Interventional Carcinoma, Transitional Cell Urinary Bladder Neoplasms Neoplasm Metastasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Vepugratinib, Placebo, EV, Pembrolizumab.
Who it may be relevant to: Registry conditions: Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Neoplasm Metastasis. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Brazil, Canada, China +14
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

Drug Vepugratinib
Administered orally
Other Placebo
Administered orally
Drug EV
Administered by IV infusion
Drug Pembrolizumab
Administered by IV infusion

Primary outcome measures

Number of participants with treatment-related adverse events related to vepugratinib in combination with EV and pembrolizumab [Time frame: From baseline up to 90 months]
Safety Lead-in: Overall Response Rate (ORR) [Time frame: From baseline up to 90 months]
Progression-free Survival (PFS) [Time frame: Baseline to Study Completion (estimated as 6 years)]

Secondary outcome measures (11)

Safety Lead-in: Disease Control Rate (DCR) [Time frame: From baseline up to the end of Cycle 2 (each Cycle is 21 days)]
Safety Lead-in: Time to Response (TTR) [Time frame: From baseline up to 90 months]
Overall Survival (OS) [Time frame: Baseline to Study Completion (estimated as 6 years)]
Objective Response Rate (ORR) by BICR [Time frame: Baseline to Study Completion (estimated as 6 years)]
Duration of Response (DoR) [Time frame: Baseline to Study Completion (estimated as 6 years)]
Progression-free Survival (PFS) [Time frame: Baseline to Study Completion (estimated as 6 years)]
Objective Response Rate (ORR) [Time frame: Baseline to Study Completion (estimated as 6 years)]
Duration of Response (DOR) [Time frame: Baseline to Study Completion (estimated as 6 years)]
Progression-free Survival 2 (PFS2) [Time frame: Baseline to Study Completion (estimated as 6 years)]
Plasma Concentrations of Vepugratinib [Time frame: Cycle 1 Day 1 to Study completion (estimated as 90 months)]
Change from Baseline in Global Health Status/Quality of Life (QOL) and Physical Function Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [Time frame: Baseline to Study Completion (estimated as 6 years)]

Eligibility 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment