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

Eligibility Criteria

• * 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
• * 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
• * Serum calcium \< ULN
• * Serum phosphate \< ULN
• * Serum creatinine ≤ 1.5 x ULN or serum creatinine \> 1.5 - 3 x ULN if calculated creatinine clearance (CrCl) is ≥ 30 mL/min using the modified Cockcroft-Gault equation
• * Patients who give a written informed consent obtained according to local guidelines
• * 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