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Could a pill shrink bladder tumors before surgery?

NCT ID NCT03914794

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Oct 2020

Finished

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

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

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

  • Associated Medical Professionals Urology

    Syracuse, New York, 13210, United States

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21205, United States

  • Keystone Urology

    Lancaster, Pennsylvania, 17604, United States

  • Midlantic Urology

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016, United States

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