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

ConditionsCarcinoma, Transitional CellUrinary Bladder NeoplasmsNeoplasm Metastasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vepugratinib

    Drug

    Administered orally

  • Placebo

    Other intervention

    Administered orally

  • EV

    Drug

    Administered by IV infusion

  • Pembrolizumab

    Drug

    Administered by IV infusion

Treatment groups

450 Participants
are divided into 3 treatment groups
Group A: Vepugratinib + EV + Pembrolizumab (Safety Lead In)Experimental treatment 3 interventions
Group B: Vepugratinib + Enfortumab Vedotin (EV) + PembrolizumabExperimental treatment 3 interventions
Group C: Placebo + EV + PembrolizumabPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

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
2

Safety Lead-in: Overall Response Rate (ORR)

ORR by Investigator Assessment.

Time frame
From baseline up to 90 months
3

Progression-free Survival (PFS)

PFS by blinded independent committee review (BICR).

Time frame
Baseline to Study Completion (estimated as 6 years)

Secondary outcomes

1

Safety Lead-in: Disease Control Rate (DCR)

DCR by investigator assessment.

Time frame
From baseline up to the end of Cycle 2 (each Cycle is 21 days)
2

Safety Lead-in: Time to Response (TTR)

TTR by investigator assessment.

Time frame
From baseline up to 90 months
3

Overall Survival (OS)

Time frame
Baseline to Study Completion (estimated as 6 years)
4

Objective Response Rate (ORR) by BICR

Time frame
Baseline to Study Completion (estimated as 6 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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