Evaluating a new treatment for high-grade non-muscle invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of NDV01, a controlled release formulation containing gemcitabine and docetaxel, administered intravesically to patients with high-grade non-muscle invasive bladder cancer (NMIBC). The formulation is designed to maximize local drug concentration while minimizing systemic exposure, allowing for continuous therapeutic effects over a 10-day period. By maintaining sustained drug levels, the study aims to improve cancer cell eradication and reduce recurrence risks compared to conventional treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Relmada Site
  Raanana, Israel Recruiting

Study contacts

• Principal investigator: Boris Chertin — Head of Urology Dep Share Tzedek Medical Center
• Study coordinator: Scott White
• Email: swhite@relmada.com
• Phone: +1 646-428-5264

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NMIBC sample collection to test cancer monitoring biomarkers

  This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.

  Recruiting Natera, Inc. · Austin, Texas · NCT07763197

• Sequential Gemcitabine Plus Docetaxel vs Gemcitabine Plus Mitomycin C for BCG-Unresponsive NMIBC

  This study tests whether adding docetaxel after gemcitabine is better or worse than adding mitomycin C after gemcitabine for people with BCG-unresponsive high-grade non-muscle-invasive bladder cancer.

  Recruiting Phase 2 Blokhin's Russian Cancer Research Center · Moscow, Moscow · NCT07747740

• Is ongoing systemic immunotherapy needed after achieving tumor-free status in very-high-risk NMIBC?

  This study tests whether patients who have become tumor-free after a systemic immunotherapy-based bladder-sparing treatment can safely stop therapy and instead be watched closely.

  Recruiting at 4 sites Phase 2 Tianjin Medical University Second Hospital · Tianjin and 3 other locations · NCT07625527

• Comparing CT and MRI with VI-RADS for Bladder Cancer Staging

  This study tests how well CT and MRI with VI-RADS can correctly stage bladder cancer before surgery in adults.

  Recruiting Oslo University Hospital · Oslo · NCT07602010

• How bladder microbes and immune signals affect lower urinary tract health

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  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07494864

• Cretostimogene for BCG‑unresponsive high‑grade non‑muscle‑invasive bladder cancer

  This treatment will test cretostimogene plus n‑dodecyl‑β‑D‑maltoside in adults whose high‑grade non‑muscle‑invasive bladder cancer did not respond to BCG (carcinoma in situ with or without Ta/T1 tumors).

  Recruiting at 14 sites Phase 2 Lepu Biopharma Co., Ltd. · Beijing, Beijing Municipality and 13 other locations · NCT07283835

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.