A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors

Completed · Phase 2

Conditions studied: Bladder Cancer, NMIBC, Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma Recurrent

In brief

This phase II trial studies how well Pemigatinib (an orally administered inhibitor of fibroblast growth factor receptors 1, 2, and 3) works in non-muscle invasive bladder cancer (NMIBC) patients with recurrent tumors and a prior history of low- or intermediate-risk NMIBC tumors. Participants will receive pemigatinib for 4-6 weeks prior to standard of care transurethral resection of bladder tumor (TURBT).

Key facts

Study ID: NCT03914794
Run by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
People needed: 30
Starts: 2020-10-02
Expected to finish: 2025-09-30
Last updated by the study team: 2025-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Prior histologically confirmed low- or intermediate-risk non-muscle invasive urothelial carcinoma of the bladder (NMIBC) defined according to the following characteristics:
Low Risk
Initial tumor with all of the following:
Solitary tumor
Ta tumor
Low-grade
<3 cm
No CIS
Intermediate Risk
-- All tumors not defined in the two adjacent categories (between the category of low- and high-risk)
High Risk
T1 tumor
High-grade
CIS
Multiple and recurrent and large (>3 cm) Ta low-grade tumors (all conditions must be met for this point on Ta low-grade tumors)
Documented tumor recurrence as noted in standard of care follow up cystoscopy.
ECOG (WHO) performance status 0-2
Age ≥ 18 years old
Patients must have the following laboratory values:
White blood cell count (WBC) > 3.0 K/mm3
Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
Platelets ≥ 100 K/mm3
Hemoglobin (Hgb) ≥ 9 g/dL
Serum total bilirubin: ≤ 1.5 x ULN
ALT and AST ≤ 3.0 x ULN

You may not qualify if…

Patients with concurrent upper urinary tract (i.e. ureter, renal pelvis) non-invasive urothelial carcinoma.
Patients with high grade urothelial carcinoma on their most recent urine cytology.
Patients with another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer. (Patients that have completed all necessary therapy and are considered to be at less than 30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment.)
Patients who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
Patients who have received prior selective fibroblast growth factor receptor targeting agents (i.e. pemigatinib, dovitinib, BGJ398, AZD4547, JNJ-42756493, etc.).
Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities
Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures (i.e. TURBT), percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury

Where it is running

Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
Associated Medical Professionals Urology — Syracuse, New York, United States
Midlantic Urology — Bala-Cynwyd, Pennsylvania, United States
Keystone Urology — Lancaster, Pennsylvania, United States
Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States

Full record on ClinicalTrials.gov

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