A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions

  • End date
    Jun 29, 2024
  • participants needed
  • sponsor
    Janssen Research & Development, LLC
Updated on 27 October 2022
growth factor
human chorionic gonadotropin
bladder cancer
invasive bladder cancer
transitional cell carcinoma
bladder tumor
bcg vaccine
intravesical chemotherapy


The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy.


This study enrolls participants with high risk NMIBC and FGFR mutations or fusions. Erdafitinib is an oral pan-fibroblast growth factor receptor (FGFR) 1-4 inhibitor with demonstrated clinical activity in participants with solid tumors, including urothelial carcinoma, with alterations in the FGFR pathway. In Cohort 1, participants will be randomized to erdafitinib or to Investigators Choice (intravesical gemcitabine or intravesical MMC/hyperthermic MMC). The study consists of Screening period, Treatment Phase and Follow-up Phase.

Condition Urinary Bladder Neoplasms
Treatment Erdafitinib, Investigator Choice (Gemcitabine), Investigator Choice (Mitomycin C)
Clinical Study IdentifierNCT04172675
SponsorJanssen Research & Development, LLC
Last Modified on27 October 2022


Yes No Not Sure

Inclusion Criteria

Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. Variant pathology are allowed
Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions
Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCG experienced participants
Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only)
Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-1
Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
A woman of childbearing potential must have a negative pregnancy test (beta-hCG [beta-human chorionic gonadotropin]) (urine or serum) within 7 days before randomization (Cohort 1) or the first dose of study drug (Cohort 2 and Cohort 3)
Adequate bone marrow, liver, and renal function as specified in the protocol

Exclusion Criteria

Histologically confirmed, muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder
Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder
Prior treatment with an FGFR inhibitor
Active malignancies other than the disease being treated under study. The only allowed exceptions are: (a) skin cancer treated within the last 24 months that is considered completely cured (b) adequately treated lobular carcinoma in situ (LCIS) and ductal CIS (c) history of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy
Current central serous retinopathy or retinal pigment epithelial detachment of any grade
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