Study of Pemigatinib for Patients with Recurrent Low- or Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03914794

Provider View

This clinical trial is testing how well the drug Pemigatinib works in patients with non-muscle invasive bladder cancer that has come back and was previously low- or intermediate-risk. Participants will take Pemigatinib for 4-6 weeks before undergoing a standard procedure to remove bladder tumors.

Patient Parameters

Program Overview

This phase II study is exploring the effectiveness of Pemigatinib, a drug taken by mouth, in treating non-muscle invasive bladder cancer (NMIBC) that has returned in patients with a history of low- or intermediate-risk tumors. Participants will receive Pemigatinib for 4-6 weeks before having a standard procedure called transurethral resection of bladder tumor (TURBT) to remove the tumors. The study aims to see how many patients have a complete response, meaning no visible cancer at the time of surgery. It will also look at the safety of the drug, how it works with different tumor types, and how much of the drug is present in bladder tissue after treatment. The study will take place at several major cancer centers in the US and is managed by Johns Hopkins Sidney Kimmel Comprehensive Cancer Center.

Description

This study is a single-arm phase II trial designed to evaluate the anti-cancer effects of Pemigatinib in patients with non-muscle invasive bladder cancer (NMIBC) that has returned and was previously classified as low- or intermediate-risk. Participants will take Pemigatinib for 4-6 weeks before undergoing a standard surgical procedure to remove bladder tumors, known as transurethral resection of bladder tumor (TURBT). The main goal is to determine the complete response rate, which means the absence of visible cancer at the time of surgery. Secondary goals include assessing the safety of Pemigatinib, examining the relationship between complete response and specific tumor characteristics, and measuring the concentration of Pemigatinib in bladder tissue after treatment. The study will be conducted at 4-5 high-volume bladder cancer centers in the US, coordinated by the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center.

Eligibility Criteria

Inclusion Criteria

  • Previously diagnosed with low- or intermediate-risk non-muscle invasive bladder cancer (NMIBC) based on specific characteristics:
    • Low Risk: Initial tumor that is solitary, Ta stage, low-grade, less than 3 cm, and no carcinoma in situ (CIS).
    • Intermediate Risk: Tumors that do not fit into low- or high-risk categories.
  • Documented tumor recurrence as seen in follow-up cystoscopy.
  • ECOG performance status of 0-2, indicating full activity or some restriction in strenuous activities.
  • Age 18 years or older.
  • Must meet specific blood test requirements:
    • White blood cell count over 3.0 K/mm3
    • Absolute neutrophil count at least 1.5 K/mm3
    • Platelets at least 100 K/mm3
    • Hemoglobin at least 9 g/dL
    • Serum total bilirubin no more than 1.5 times the upper limit of normal (ULN)
    • ALT and AST no more than 3 times ULN
    • Serum calcium and phosphate below ULN
    • Serum creatinine no more than 1.5 times ULN, or if higher, creatinine clearance at least 30 mL/min
  • Must provide written informed consent according to local guidelines.

Exclusion Criteria

  • Have non-invasive urothelial carcinoma in the upper urinary tract (ureter, renal pelvis).
  • Have high-grade urothelial carcinoma in recent urine tests.
  • Have another active cancer, except for non-melanoma skin cancers and certain prostate cancers.
  • Have received anti-cancer therapy, including chemotherapy or immunotherapy, within 4 weeks before starting the study drug, or have not recovered from its side effects.
  • Have previously taken drugs targeting fibroblast growth factor receptors, like Pemigatinib.
  • Have had radiotherapy within 4 weeks before starting the study drug, or have not recovered from its side effects.
  • Have had major surgery or significant injury within 4 weeks before starting the study drug, or minor procedures within 1 week, or have not recovered from their side effects.

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