Brief Title: Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Bladder Cancer
• NMIBC
• Non-Muscle Invasive Bladder Cancer
• Urothelial Carcinoma Recurrent

ELIGIBILITY

Inclusion 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
--- 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

- * 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
Exclusion Criteria:
* 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Noah M Hahn, MD

Role: Principal Investigator

Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Overall Contact

Name: Amber Michalik, BA, Rana Sullivan, RN

Phone: 667-306-8336, 410-614-6337

Email: amichal2@jhmi.edu, tomalra@jhmi.edu

LOCATION