Could a pill shrink bladder tumors before surgery?
NCT ID NCT03914794
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tested pemigatinib, a daily pill that blocks certain growth signals, in 30 people with recurrent low- or intermediate-risk non-muscle invasive bladder cancer. Participants took the drug for 4-6 weeks before their standard surgery to remove bladder tumors. The main goal was to see if the drug could make tumors disappear completely before surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pemigatinib (a drug that blocks certain growth signals in cancer cells)
- What this could lead to
- If it works, this could offer a new treatment option for people with recurrent low- or intermediate-risk bladder cancer, potentially reducing the need for repeated surgeries.
- What could go wrong
- This is a small, early-phase trial with only 30 participants. The drug may not work for everyone, and side effects are possible. Results may not apply to all bladder cancer patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
30 people
The number who actually took part.
- Started
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Oct 2020
- Finished
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Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Associated Medical Professionals Urology
Syracuse, New York, 13210, United States
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Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
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Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21205, United States
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Keystone Urology
Lancaster, Pennsylvania, 17604, United States
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Midlantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
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Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Lab-Grown tumor organoids could pick the right bladder chemo
- Chemo gel delivered directly to kidney tumors: can it help when other options run out?
- Can tumor genes decide who keeps their bladder?
- Lab-Grown tumor models could match patients to the right cancer drug
- Can heated saline during bladder surgery stop tumors from coming back?
- Radiation instead of bladder removal: a new option for Hard-to-Treat bladder cancer?