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

Conditions

• Urothelial Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Erdafitinib — DRUG
  Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.
• Vinflunine — DRUG
  Participants will receive vinflunine 320 mg/m\^2 as a 20-minute intravenous infusion.
• Docetaxel — DRUG
  Participants will receive docetaxel 75 mg/m\^2 as a 1 hour intravenous infusion.
• Pembrolizumab — DRUG
  Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.
• Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) — DEVICE
  FGFRi CTA will be used to determine molecular eligibility.

Study Details

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).

Key Dates

Start date

Mar 23, 2018

Status verified

Jun 2026

Primary completion

Apr 15, 2024

Completion

Dec 31, 2026

Study Design

Enrollment

629 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1 (Arm 1A): Erdafitinib
  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.
• Experimental: Cohort 1 (Arm 1B): Vinflunine or Docetaxel
  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.
• Experimental: Cohort 2 (Arm 2A): Erdafitinib
  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.
• Experimental: Cohort 2 (Arm 2B): Pembrolizumab
  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.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From randomization (3 days prior to Cycle 1 Day 1) until death due to any cause (maximum up to 51.7 months) ]

Locations (26)

Related coverage on Hipa.ai

• Pembrolizumab's OS in Urothelial Cancer Trial: 11.07 Months as Comparator
  Pembrolizumab · May 14, 2025 · ClinicalTrials.gov
• Pembrolizumab: Erdafitinib Shows Better PFS/ORR in Urothelial Cancer Trial
  Pembrolizumab · Apr 15, 2024 · ClinicalTrials.gov

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