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A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Status
Active
Cancer Type
Bladder Cancer
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04172675
Protocol IDs
CR108699 (primary)
NCI-2020-00674
42756493BLC2003
2019-002449-39
Study Sponsor
Janssen Research & Development, LLC

Summary

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.

Objectives

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.

Eligibility

  1. Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. Variant pathology are allowed
  2. Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions
  3. Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCG experienced participants
  4. Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only)
  5. Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-1
  6. 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
  7. 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)
  8. Adequate bone marrow, liver, and renal function as specified in the protocol
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.