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

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Incyte Corporation

Criteria

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