Erdafitinib for Bladder Cancer
(THOR Trial)

Recruiting in Palo Alto (17 mi)

+409 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-\[L\]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).

Eligibility Criteria

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.

Inclusion Criteria

Documented progression of disease prior to randomization

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

Negative pregnancy test for sexually active women of childbearing potential at Screening

+6 more

Exclusion Criteria

Treatment with any other investigational agent within 30 days prior to randomization

I am not allergic to erdafitinib or its ingredients.

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

+5 more

Participant Groups

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.

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.

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Taxotere for: