Can a chemo gel spare the bladder in cancer?
NCT ID NCT06663137
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This phase 2 trial tests a treatment called NDV-01 KIT for people with high-grade non-muscle invasive bladder cancer (NMIBC). The treatment is a gel containing two chemotherapy drugs, gemcitabine and docetaxel, which is placed directly into the bladder through a catheter. Participants receive the gel every two weeks for six treatments, then monthly for up to a year. The study measures how many people have a complete response, meaning no signs of cancer, and how long that response lasts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NDV-01 KIT, a gel containing gemcitabine and docetaxel, given directly into the bladder via a catheter
- What this could lead to
- If it works, this could offer a bladder-sparing option for people with high-grade non-muscle invasive bladder cancer who cannot or choose not to have their bladder removed.
- What could go wrong
- This is a small, single-arm phase 2 trial, so results may not be conclusive. The treatment may cause side effects, and it is not yet known if it will be more effective than standard care.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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.
Subjects may participate in the study if they meet all the following criteria: Inclusion criteria: * Aged 18 - 80 years old * Able to give informed consent * Histologically confirmed diagnosis of high grade non-muscle invasive bladder cancer (NMIBC) - patients having high-grade disease at first evaluation after induction BCG alone (at least 5 of 6 doses) may qualify in the absence of disease progression. * Participants must be ineligible for or have elected not to undergo radical cystectomy. * Available for the whole duration of the study. * Life expectancy \>2 years, in the opinion of the investigator. * Eastern Cooperative Oncology Group (ECOG) status 2 or less. * Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumor by either intravenous pyelogram, retrograde pyelogram, computed tomography (CT) scan with or without urogram, or MRI with or without urogram performed within 6 months of enrolment. * Patients with prostate cancer on active surveillance at low risk for progression, defined as Prostate-Specific Antigen (PSA) \< 10 ng/dL, Gleason score 6 and clinical stage tumor-1 (cT1) are permitted to be in the study at the discretion of the investigator (see exclusion criterion 10). * Female patients of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for 1 month following the last study drug infusion and must have a negative urine or serum pregnancy test upon entry into this study. Otherwise, female patients must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile. 'Maximally effective birth control' means that the patient, if sexually active, should be using a combination of two methods of birth control that are approved and recognized to be effective by Regulatory Agencies. Exclusion criteria: * Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented. Examples that increase the risk of metastatic disease are (but not limited to): * Presence of lymphovascular invasion and/micropapillary disease as shown in the histology of the biopsy sample. * Patients with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor - Unless scheduled for treatment like nephrostomy or JJ stent insertion.. * Current systemic therapy for bladder cancer. * Symptomatic urinary tract infection or bacterial cystitis (once satisfactorily treated, patients can enter the study). * Clinically significant and unexplained elevated liver or renal function tests. * Women who are pregnant or lactating or refuse to commit to using contraception anytime during the study. * Any other significant disease or other clinical findings which in the investigator's opinion would prevent study entry. * History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤ pathological tumor-2 (pT2) upper tract urothelial carcinoma at least 24 months after nephroureterectomy.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Relmada Site
RECRUITINGRaanana, 4363007, Israel
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Other studies related to the condition(s) this trial covers.
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- Can a new drug help keep bladder cancer at bay?