Bladder cancer drug trial pulled before it even started
NCT ID NCT07313891
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This was a planned Phase 3 study comparing a new drug, NDV-01 (a combination of two chemotherapy drugs), against simple observation in people with intermediate-risk non-muscle invasive bladder cancer. The goal was to see if the drug could prevent the cancer from coming back after surgery. However, the trial was withdrawn before enrolling any participants, so no data was collected.
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 (sustained-release gemcitabine-docetaxel)
- What this could lead to
- If it worked, this could offer a new treatment option to reduce bladder cancer recurrence after surgery.
- What could go wrong
- The trial was withdrawn before any participants enrolled, so no results are available. It is unclear if the drug is safe or effective.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Expected to start
-
May 2026
An estimate. Start dates often move.
- Expected to finish
-
Nov 2029
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
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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 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.
Inclusion Criteria: 1. Have a histologically confirmed diagnosis (within 90 days of randomization) of IR NMIBC based on the AUA/SUO criteria of IR NMIBC. 2. Participants must have ≥ 1 IBCG risk factors: multiple tumors, early recurrence (Within 1 year), frequent recurrences (\> 1 per year), tumor size (\> 3 cm), failure of prior intravesical therapy. 3. Visible papillary disease must be fully resected prior to randomization, and absence of disease must be documented at Screening cystoscopy. The same method for visualizing disease at Screening cystoscopy should be used throughout for the participant (white light versus enhanced assessment method). 4. Patients with LG T1 may be eligible after repeat-TURBT (within 4 weeks of first TURBT) if the repeat pathology shows non-invasive (Ta or less) or no disease. Original and repeat-TURBT must confirm that muscularis propria is present and uninvolved in the specimen. TURBT to occur within 4 months of screening. All pathology specimens must be predominantly urothelial (transitional cell) and have less than 20% variant (e.g., sarcomatoid, squamous component) histology. Exclusion Criteria: 1. Histologically confirmed diagnosis of HR NMIBC (including CIS) or MIBC, locally advanced, nonresectable, or metastatic urothelial carcinoma at any time prior to enrollment. 2. Has had urothelial carcinoma outside of the urinary bladder, (including prostatic 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. 3. Participant has tumor(s) involving the prostatic urethra (ductal or stromal). 4. N+ and/or M+ per CT/MR urography.
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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.
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