A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors
Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Apr 11, 2019
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called Pemigatinib to see how well it works for patients with non-muscle invasive bladder cancer (NMIBC) who have had their tumors come back. The trial specifically focuses on patients who have a history of low- or intermediate-risk NMIBC tumors. If you qualify, you will take Pemigatinib for 4 to 6 weeks before having a standard procedure to remove the bladder tumors called transurethral resection of bladder tumor (TURBT).
To be eligible for this study, you need to be at least 18 years old and have had a confirmed diagnosis of low- or intermediate-risk NMIBC. You should also be able to take part in the study without any major health issues that would prevent you from receiving the medication. During the trial, participants will be monitored closely, and those who agree to join will need to provide written consent. This trial is currently recruiting participants, so if you or a loved one are interested, it might be a good opportunity to explore new treatment options.
Gender
ALL
Eligibility 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
About Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is a leading research and treatment facility dedicated to advancing the understanding and treatment of cancer. Renowned for its multidisciplinary approach, the center integrates cutting-edge research with patient care, fostering innovation in cancer therapies and prevention strategies. With a commitment to translational medicine, the center conducts clinical trials that aim to bring laboratory discoveries directly to patients, enhancing therapeutic options and improving outcomes. As a National Cancer Institute-designated comprehensive cancer center, it emphasizes collaboration among researchers, clinicians, and patients to tackle the complexities of cancer and develop personalized treatment plans.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Washington, District Of Columbia, United States
Myrtle Beach, South Carolina, United States
Baltimore, Maryland, United States
Bala Cynwyd, Pennsylvania, United States
Syracuse, New York, United States
Lancaster, Pennsylvania, United States
Patients applied
Trial Officials
Noah M Hahn, MD
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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