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Chemotherapy Agent

Erdafitinib for Bladder Cancer (THOR Trial)

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Metastatic or surgically unresectable urothelial cancer

Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy with no more than 2 prior lines of systemic treatment for Cohort 1

Must not have

Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients

History of uncontrolled cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately up to 3 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare the effectiveness of erdafitinib to chemotherapy or pembrolizumab in treating urothelial cancer that has progressed after 1-2 prior treatments.

Who is the study for?

This trial is for adults with advanced bladder cancer that has worsened after treatment. Participants must have specific FGFR gene changes, and can join one of two groups: those who've had up to two treatments including an anti-PD-(L)1 drug, or those who've had just one prior treatment without an anti-PD-(L)1 drug. They should be relatively healthy otherwise and not pregnant if they're women of childbearing age.

What is being tested?

The study compares the effectiveness of a new medication called Erdafitinib against either chemotherapy drugs Vinflunine or Docetaxel, or immunotherapy Pembrolizumab in patients whose bladder cancer has specific genetic markers and has progressed despite previous treatments.

What are the potential side effects?

Erdafitinib may cause mouth sores, nail changes, skin rash, diarrhea, dry mouth and altered taste. Chemotherapy can lead to fatigue, nausea, hair loss and increased risk of infection. Pembrolizumab might result in immune system reactions affecting organs like lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My bladder cancer has spread or cannot be removed by surgery.

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I've had treatment with an anti-PD-(L)1 drug, with no more than 2 treatments for my condition.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to erdafitinib or its ingredients.

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I have a history of heart disease that is not well-controlled.

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My wounds heal slowly or poorly.

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I have symptoms from cancer spread to my brain.

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I have been treated with FGFR inhibitors before.

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I have a current diagnosis of CSR or retinal detachment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib

Change from Baseline in Participant-Reported Health Status and Physical Functioning Scales of the Functional Assessment of Cancer Therapy (FACT-Bl)

Change from Baseline in Patient-Global Impression of Severity (PGIS) Score

+8 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 2 (Arm 2B): PembrolizumabExperimental Treatment2 Interventions

Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-\[L\] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities. Participants who enter in LTE phase will continue to receive the pembrolizumab until 2 years after the first dose of pembrolizumab (at start of study) or until the participant can commercially receive pembrolizumab within the local healthcare system, whichever comes first.

Group II: Cohort 2 (Arm 2A): ErdafitinibExperimental Treatment2 Interventions

Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-\[L\] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs). Participants who enter in LTE phase will continue to receive the erdafitinib tablet as per investigator's decision.

Group III: Cohort 1 (Arm 1B): Vinflunine or DocetaxelExperimental Treatment3 Interventions

Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-\[L\] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m\^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m\^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities. Participants who enter in LTE phase will continue to receive Vinflunine or Docetaxel until the participant can commercially receive chemotherapy within the local healthcare system.

Group IV: Cohort 1 (Arm 1A): ErdafitinibExperimental Treatment2 Interventions

Participants will be screened based on Fibroblast Growth Factor Receptor Inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-\[L\] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events \[AEs\]). Participants who enter in Long-term extension (LTE) phase will continue to receive the erdafitinib tablet as per investigator's decision.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

Pembrolizumab

2017

Completed Phase 3

~2810