A Phase 3 interventional study of NDV-01 (sustained-release gemcitabine-docetaxel) in Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive) and Urothelial Carcinoma Bladder, sponsored by Relmada Therapeutics, Inc.. Withdrawn. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Relmada Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This is a Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have failed first-line therapy for BCG-unresponsive NMIBC (approved or in development) and are recommended for radical cystectomy.
This is a Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have failed first-line therapy for BCG-unresponsive NMIBC (approved or in development) and are recommended for radical cystectomy.
Participants will receive an induction course and then monthly maintenance courses of NDV-1 (sustained-release gemcitabine-docetaxel) through 3 years, if there is no disease recurrence.
Participants will received an induction course of NDV-01 (6-bi-weekly intravesical instillations). Those who achieve a complete response (CR) at 3 months will be eligible for monthly maintenance instillations through year 3.
Disease status will be assessed using urine cytology, cystoscopy, and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization or until disease recurrence.
155 studies on the registry are indexed under Urologic Neoplasms; 40 are open to participants now.
Browse Urologic Neoplasms studies →Relmada Therapeutics, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Compared within Urologic Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Has had urothelial carcinoma outside of the urinary bladder (i.e., urethra, ureter, or renal pelvis) or has a predominant histological variant of UC. Ta/any T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study: Participant has tumor(s) involving the prostatic urethra (ductal or stromal); N+ and/or M+ per computerized tomography (CT)/Magnetic Resonance Imagery (MR) urography. History of prior T2/T3 urothelial carcinoma of the bladder.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: NDV-01 (sustained-release gemcitabine-docetaxel) Description: Intravesical instillation of NDV-01 (sustained-release gemcitabine-docetaxel)
Drug: NDV-01 (sustained-release gemcitabine-docetaxel)
Intravesical instillation of NDV-01 (sustained-release gemcitabine-docetaxel)
To evaluate the efficacy of NDV-01 (determined by complete response [CR] anytime) administered by intravesical instillation in patients with BCG-unresponsive NMIBC who have recurred after first-line intravesical therapy (approved or in development).
Percentage of participants with CR at anytime based on cystoscopy, urine cytology, and biopsies. Protocol-driven mapping biopsies (as assessed by central pathology) will be performed at 12 months
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sustained-Release Gemcitabine-Docetaxel NDV-01
Relmada Therapeutics, Inc.