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

An Open Label, Single Arm Study, to Evaluate the Safety and Efficacy of NDV01 KIT in Patients With High Grade Non Muscle Invasive Bladder Cancer (NMIBC)

This study is testing a new bladder cancer treatment that delivers medication directly into the bladder to see if it can better kill cancer cells and lower the chances of the cancer coming back for people with high-grade non-muscle invasive bladder cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Relmada Therapeutics, Inc. (Industry-sponsored)
• Locations: 1 site (Raanana)
• Trial ID: NCT06663137 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed high-grade NMIBC who are ineligible for or have chosen not to undergo radical cystectomy.

Not a fit: Patients with low-grade NMIBC or those with upper tract urothelial carcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with high-grade NMIBC by reducing recurrence rates and enhancing local drug efficacy.

How similar studies have performed: While this approach is innovative, similar studies using intravesical therapies have shown promise in treating NMIBC, suggesting potential for success.

Eligibility criteria

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 this trial is running

Raanana

• Relmada Site — Raanana, Israel (Recruiting)

Study contacts

• Principal investigator: Boris Chertin — Head of Urology Dep Share Tzedek Medical Center
• Study coordinator: Paul Greene

Conditions Non Muscle Invasive Bladder Cancer