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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately up to 3 years

Awards & highlights

THOR Trial 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.Check my eligibility

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.See study design

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.

THOR Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

Select...

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

THOR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

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

THOR 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

~5620

Pembrolizumab

2017

Completed Phase 2

~2010

Erdafitinib

2017

Completed Phase 2

~150

Vinflunine

2014

Completed Phase 3

~1740

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,383,679 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,276 Total Patients Enrolled

Media Library

Docetaxel (Chemotherapy Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03390504 — Phase 3

Bladder Cancer Research Study Groups: Cohort 1 (Arm 1A): Erdafitinib, Cohort 2 (Arm 2B): Pembrolizumab, Cohort 2 (Arm 2A): Erdafitinib, Cohort 1 (Arm 1B): Vinflunine or Docetaxel

Bladder Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT03390504 — Phase 3

Docetaxel (Chemotherapy Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03390504 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions does Pembrolizumab help to ameliorate?

"Pembrolizumab can be used as a treatment for patients suffering from malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

What does the Food and Drug Administration have to say about Pembrolizumab?

"Pembrolizumab is a Phase 3 medication, meaning that while there is efficacy data available, its safety has been corroborated by multiple rounds of clinical trials."

Answered by AI

If this research is being conducted in more than one location, which states are they located in?

"This trial is being conducted at 7 sites across North America, with the closest locations to Houston, Vancouver and Kelowna. If you enroll in this study, it is important to try and be assigned a site that is close to minimize travel requirements."

Answered by AI

Are there other notable scientific papers that have been published about Pembrolizumab?

"Currently, there are a total of 1319 ongoing clinical trials investigating Pembrolizumab with 243 in Phase 3. The majority of these studies for Pembrolizumab are located in Pittsburgh, Pennsylvania; however, there are 58065 locations operating trials for Pembrolizumab worldwide."

Answered by AI

Are people in need of this medication able to sign up for the trial at this time?

"This study is still recruiting patients, according to the website clinicaltrials.gov. The listing for this trial was first posted on March 23rd, 2018 and was last edited on November 3rd, 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

2018. "A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03390504.

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